Event Alert

Wednesday, December 2nd, 2020

Mehdi Saghafi,  Senior Staff Development Scientist, Bayer

With constraints on personnel and budgets, committing to a purchase of equipment can be difficult without understanding the flexibility and longevity such equipment can provide. Mehdi Saghafi, Sr. Scientist at Bayer, discusses why they chose Seg-Flow autosampler for their upstream lab and the impact of the autosampler on quality of life and data acquisition. In this talk, he will present on the implementation, remote control, and process automation. This will be followed with a short overview of the Seg-Flow system and a Q&A session.
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Wednesday, November 25th, 2020

Martin T., Head of Global Sales and Project Management

Get to know our RoSS (Robust Storage and Shipping) Platform for single use bags:
We will demonstrate the unrivalled features and benefits from the protective shell directly from Kufstein, Austria and it is the perfect opportunity for you to ask us whatever you always wanted to know - in our live-webinar.
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Thursday, November 19th, 2020

Michael Payne, Principal Technical Consultant, Aseptic Processing

Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better processes and analytical monitoring and control at both early and final phase production.

The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies. 
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Thursday, November 19th, 2020

Abhay Kini
Director of Product Management, IDBS

No business is immune to change. A strategic approach to embracing technology can dramatically enhance an organization’s ability to respond to a dynamic business climate.  Such changes have forced every organization to accelerate their digital transformation to build a more agile and adaptable workforce. 
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Wednesday, November 18th, 2020

Vinit Saxena, CEO & Founder of Sepragen Corporation 

Radial Flow Columns provide an elegant, simple and proven way to scale up sample volumes and flow rates in small diameter (Small footprint) columns. The Radial Flow Columns, termed Superflo®, can be used with any Ion Exchange, Affinity & Hydrophobic Interaction Chromatographic resin.
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Thursday, November 19th, 2020

David Serway, Global Director, Single-Use TFF Systems

The explosive growth in biologics and gene therapies, the globalization of biomanufacturing, and the pressures to reduce capital investment and cost of goods while accelerating speed to market all point to changes in how bioprocessing systems/skids are designed, built, and operated. Future hardware, software, and consumables built on the principle of flexibility and extensive use of single-use, closed, complete, and ready-to-operate technologies will be described. This presentation will summarize Repligen systems for tangential flow filtration (TFF) that combine unparalleled configurability with premium quality manufacturing. 
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Wednesday, November 18th, 2020

David Stauffer, VP of Automation Services at Aztec Technologies

This seminar will discuss the use case for and development of a Part 11 compliant solution to support manual data entry into an OSI PI Historian. This allows life sciences users to combine data collected for electronic instrumentation, with data read by an operator for analog instrumentation which was otherwise unable to communicate with the system.

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Tuesday, November 17th, 2020

This fifth webinar in a series of 5 dealing with vaccine production focuses on formulation and filling. Formulation and filling is a critical part of any drug manufacturing process and demands the highest levels of quality and reliability. Pall has a range of technologies and services that enables end users to carry out their operations with increased reliability and flexibility – while ensuring the product quality is designed into the manufacturing process. Using technology from the Allegro™ single-use portfolio, Pall sterilizing grade filters and Pall’s automated solutions ensure that manual interventions are minimized and increased sterility assurance is achieved.

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Friday, November 13th, 2020

Robert Guenard, at Biogen
Petter Moree, at OSIsoft
Mark Demesmaeker at Sartorius Stedim Data Analytics

Over the years there have been many frames of reference on the use of process analytical technology including monitoring, closed loop control, quality control/real time release, advanced process control, quality by design, Industry 4.0, etc. With each evolution of framing, the context we view process analysis of manufacturing processes is trending towards expanded scope and context from unit operation, to production train and plant level up through manufacturing network, supply chain and value chain to customer. In this talk we will present how we at Biogen are applying technology capabilities on a pathway towards realization of Smart Manufacturing by keeping the greater context in mind and delivering value added process analytics capabilities.

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Tuesday, November 17th - Thursday, November 26th, 2020

This course will provide you with the knowledge to understand the purification process and packing methods to get the most from preparative chromatography. These live sessions are virtual versions of our regular face-to-face training. The entire training is broadcast over 4 90-minute sessions, on 4 days spaced over 2 weeks. This course is designed for R&D or production systems users, technicians, engineers, managers, and anyone interested in learning HPLC theory and techniques to develop production processes.

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Thursday, November 12, 2020

Gerben Zijlstra, Senior Platform Technology Consultant

The Biopharma industry is challenged by costs pressures, increasing numbers of low volume products with unpredictable demand and the advent of new less stable molecules, like bi-and multi-specifics that may not always be suitable for production in the standard Fed-Batch platforms.

In this webinar, Sartorius will walk you through the product life cycle using a comprehensive toolbox for the development and implementation of intensified upstream processes. The webinar will first highlight the cell line generation service for perfusion compatible cell lines and media along with high cell density cell banking. Subsequently, capabilities and data will be shared on high -throughput Ambr® perfusion and benchtop perfusion development tools, with integrated PAT tools for highly efficient process design and design space mapping. Subsequently, we will share how your process insight will dramatically increase and your scale-up journey will be made simple, using enhanced software tools in combination with commercial scale stirred tank and rocker bioreactors with integrated perfusion capabilities.

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Wednesday, November 11th, 2020

Dielectric spectroscopy (DS), also known as capacitance technology, has been widely used as a PAT tool to measure biomass in real time, in various applications involving mammalian, insect, bacterial and microbial cells. It has been viewed as a particularly useful technology to measure cells in challenging microbial and bacterial applications, where other methods struggle to measure cell density reliably.

This webinar will start with an introduction to the invention of the technology and how the technology works (principle of measurement). Following this, the application of this technology in microbial and bacterial processes will be described with real world customer data. Relationship between capacitance and offline measurements such as dry weight and optical density will be demonstrated. Case studies will be presented where capacitance technology has been used for process fingerprinting, harvest time optimization, productivity improvement, real time troubleshooting and automatic process control. 
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Tuesday, November 10th, 2020

Dr. Michael Lasse, Product Manager Virus Clearance

Manufacturers of plasma-derived medicinal products (PDMPs) face increased challenges as the main raw material is of human origin and can therefore be contaminated with pathogens capable of causing direct infections in patients. Furthermore, routinely conducted testing on adventitious viruses is often limited to known contaminants and can easily fail on emerging and other unknown viruses. These circumstances not only present key challenges for scientists and engineers in downstream processing, but may also be of regulatory relevance. In this webinar, we will discuss the challenges and points that need to be considered when implementing virus safety concepts and present the benefits of virus filtration when it comes to establishing effective and reliable virus clearance steps within PDMP production. Furthermore, we will highlight the importance of robust, scalable virus clearance technologies such as Virosart® HC for the removal of emerging viruses like SARS-CoV-2 in biopharmaceutical manufacturing.
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Tuesday, November 10th, 2020

Asahi Kasei Bioprocess America, Inc. is offering the November Planova Operators Course via Teams video conferencing.  This training course will be held 'live' for active participation and questions. We'll provide the classroom and in-lab demonstrations by an operator in real time, as we teach and show virus removal methods.
Discussion will be interactive, and space is limited. 
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Tuesday, November 10, 2020

Christian Weilke, PhD,
Director International Product Management                  
Roche Custom Biotech

With a broad test portfolio, Cedex Analyzers provide precise information about the nutrient, metabolite and product status of cultures, as well as cell viability and growth rate. The new Sodium test is the latest example of system improvement. This kit enables convenient photometric detection of sodium concentrations replacing the ISE method. A new hardware module equips existing instruments with the ability to process 96-well sample plates for high-throughput analysis. With a continuously expanding Cedex test portfolio and additional resources for the system integration, you are perfectly prepared to improve your process control and to continuously optimize your bioprocessing in the future.

Join this webinar to learn why Roche Pharmaceuticals counts on Cedex Bio Analyzers for their own manufacturing and get answers about building a reliable bio-process control system.

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Friday, November 6th, 2020

Scott Hluhanich
Danaher Business System Leader
IDBS

This presentation will explore tools that biopharma development organizations can use to prepare for digital transformation. We will discuss tools that help companies visualize complex processes in a simple diagram, tools for identifying waste and inefficiency in the process, and tools for visualizing the steps of complex processes.

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Friday, November 6th, 2020

This session covers answers from 3M and WPI experts for your pre-submitted technical questions from the course.  This is also a live webinar with the instructors of the 'Biopharma Clarification Filtration' Course.  Complete a short quiz during this session to receive your participation certificate from 3M Healthcare Academy.

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Tuesday, November 3rd, 2020

There is no single vaccine manufacturing approach. There are, however, flexible technologies that can meet each of the challenges during process development and at GMP scale. Accelerating vaccine development and manufacturing by coupling research advances in vaccine technology with systems that support agility through a Quality by Design approach is critical to deliver life-saving immunizations to those in need globally. Diversity in the type of vaccine antigen, along with the inherent variation in the targets, have created challenges for vaccine manufacturers when compared to a relatively small number of platform processes that exist. There are flexible technologies that can meet each of the challenges during PD and at GMP scale.

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Wednesday, November 4th, 2020

Speakers: Scott Weiss, VP Product Strategy

Often, scientific R&D data is not replicable or re-useable, holding a company back. In addition to racking up costs, it highlights that there are important things that need to be transformed in R&D. When it comes to technology, you need a collaborative environment, a usable and intuitive platform. You need user-friendly configurations, interoperability and integration, and a strong scientific informatics platform in place to manage and map the massive amounts of data. In this webinar, Scott Weiss, VP of Product strategy at IDBS, will take us through building an ecosystem that not only fills a need, but also fits into your lab's workflows to drive R&D processes and ensure data is in an accessible and digestible format.

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Thursday, November 5th, 2020

Speakers: Jorge Escober, Senior Research Scientist and Aurelie Tacheny, Project Manager and Application Specialist at Eppendorf

Exosomes are a population of naturally occurring mobile, membrane-limited, 30 - 100 nm in diameter, extracellular vesicles containing a large number of proteins, lipids, messenger, and micro-RNAs. Stirred-tank bioreactors offer the possibility to tightly control and monitor the production of exosomes, as well as the scalability, to produce increasing amounts. However, the cultivation of stem cells in stirred-tank bioreactors requires profound knowledge and precise control of the process. In our talk, we will highlight the potential and benefits of stirred-tank bioreactors in the cultivation of stem cells for exosome production.

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Tuesday, October 27th, 2020

Speaker: Oren Ben-Yosef, Product Manager for Stem Cells, Advanced Therapies

In the stem cell clinical research and applications field, regulations are all-encompassing and very relevant. When a researcher is moving from the Academia to the Industry, or a Start-Up is considering expanding and honing its clinical tools, it is important to know what the considerations are for choosing the correct stem cell media, and as important the media supplier. This webinar is intended for familiarizing oneself in media regulatory terminology, showcasing Sartorius QMS, and highlighting the relevant stem cell media and clinical uses.

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Tuesday, November 3rd, 2020

This fourth webinar in a series of 5 explores downstream process development for vaccine manufacturing. The purification of vaccines and gene therapy/viral vector products is a key part of a drug manufacturing process that requires high levels of product purity and process reproducibility. Pall has a range of technologies and offers field-based support and lab-based process development services that enable end users to purify and recover their high-value products. The process strategies to improve purity and yield as well as the challenges associated the purification of viral vector process will be discussed.

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Friday, October 23rd, 2020

Presented by Dejan Arzensek, Principal Scientist at Novartis, Followed by an industry perspective presented by Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc.

The discussion will be focused around the exploration of multiple techniques and their possibilities to secure tight control of the major critical quality attributes (CQA) and different PAT tools for measuring different attributes in (near) real-time. A feasibility study of PAT tools covered in this talk demonstrates the technology for in-line measurements in fed-batch process steps and potential of their use in a continuous process.

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Thursday, October 22nd, 2020

Anchorage-dependent cells such as vero cells are widely used as a platform for viral vector production. To cultivate vero cells in stirred-tank bioreactors, a growth matrix for the cells to attach to is required. The development of processes at bench scale is crucial to establish cost-efficient workflows in larger volumes.

In this webinar, an expert will demonstrate how different process parameter can be monitored and controlled in a perfusion bioprocess to cultivate anchorage-dependent cells. The presentation will demonstrate the potential of using packed-bed bioreactors or a microcarrier spin filter for attachment cell-based vaccine production.

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Wednesday, October 21st, 2020

Presenters: Douglas Marsh, Senior Scientist, Gyroscope, Aline Hughson, Process Scientist, Gyroscope and Quentin Vicard, Sartorious

Scaling up a process developed in shake flasks to manufacturing scale requires different agitation and may impact process performance. Shake flasks are typically used at early stage process development for production and seed cell growth but replaced with stirred tanks and rocked bags respectively as scale increases. Biostat® RM combined with Ambr® were used to map out the agitation design space of the both the seed and production systems to establish appropriate operating parameters for large-scale. A method for quantifying the level of cell aggregation was also developed to allow comparison between systems. This showed the importance of configuring agitation to maximise productivity. Overall, it was found that agitation had a significant effect on productivity and that different agitation rates are beneficial at different stages of the process. Appropriate agitation for Biostat® RM when used as a seed vessel had the potential to increase titre by 50% for stirred tank production. Optimising agitation rate during production in Biostat® RM could increase titre by several-fold.

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Tuesday, October 27th, 2020

Speaker: Oren Ben-Yosef, Product Manager for Stem Cells, Advanced Therapies

In the stem cell clinical research and applications field, regulations are all-encompassing and very relevant. When a researcher is moving from the Academia to the Industry, or a Start-Up is considering expanding and honing its clinical tools, it is important to know what the considerations are for choosing the correct stem cell media, and as important the media supplier. This webinar is intended for familiarizing oneself in media regulatory terminology, showcasing Sartorius QMS, and highlighting the relevant stem cell media and clinical uses.

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Wednesday, October 21st, 2020

Registration is live for the next webinar in the BPSA Speaker Series. Hear from Hélène Pora (Pall Biotech), Charlotte Masy (GSK Vaccines), and Marc Hogreve (Sartorius Stedim Biotech) to learn:

  • Why integrity of single-use systems matters
  • What is the regulatory landscape 
  • What are the best practises developed by suppliers and end users 
  • Which integrity test method can be applied
  • How an end-user has successfully applied all this

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Wednesday, October 21st, 2020

Asahi Kasei Bioprocess America, Inc. is offering the Fall Planova Operators Course via Teams video conferencing. This training course will be held 'live' for active participation and questions. We'll provide the classroom and in-lab demonstrations by an operator in real time, as we teach and show virus removal methods.

Discussion will be interactive, and space is limited.

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Tuesday, October 13th, 2020

The benefits of magnetic mixing technology for aseptic production processes are manifold. Minimizing the risk of contamination and significantly reducing maintenance times are just two of the advantages of this state-of-the-art agitator technology over conventional mechanical seals. ZETA not only supplies magnetic agitators for new bioreactors, but also supports its customers through the entire retrofitting process - from feasibility studies at the beginning to full process qualification and validation at the end.

Nicole Zangl and Lindsay Smart will host this ZETA Webinar, highlighting case studies to illustrate how challenges were overcome and which best-practice solutions have been developed to execute successful retrofitting projects.

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Wednesday, October 14th, 2020

Rapid progress in biotechnology and the ever-increasing complexity of medicines presents bioprocessing with significant challenges. Novel technologies such as single-use and continuous manufacturing are revolutionizing industry processes. We at Levitronix believe that impactful bioprocessing can only be achieved if end-users, system, and components suppliers work together. The Levitronix Bioprocessing Webinar brings industry professionals together to make a change.

Speakers: 

  • Samantha Cramer, Oakwood Labs, Formulations Engineer III, "Using Levitronix pumps in various unit operations of the microsphere manufacturing process"
  • Dr. Tizian Bucher, Dr. Mueller AG, R&D Engineer, "Cell Harvest using Cyclical Cake Filtration"
  • Thomas Herrmann, StemVac GmbH, Director Translational R&D and Manufacturing, "Trojan horses fighting cancer: The next level in oncolytic virus therapy"

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US / Tuesday, October 27th, 2020

Europe / Thursday, October 29th, 2020

Register today for a Repligen virtual seminar on Gene Therapy Manufacturing 2.0 chaired by Matthias Hebben from Logic Bio Therapeutics with industry speakers from Catalent, Genopis, Oxford Biomedica, and more. Industry case studies will discuss Gene Therapy Manufacturing 2.0 technologies where viral vectors are continuously produced using intensified suspension cell culture ran in perfusion mode, and purified through a secured and high efficiency downstream process.

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Wednesday, October 14th, 2020

Rapid progress in biotechnology and the ever-increasing complexity of medicines presents bioprocessing with significant challenges. Novel technologies such as single-use and continuous manufacturing are revolutionizing industry processes. We at Levitronix believe that impactful bioprocessing can only be achieved if end-users, system, and components suppliers work together. The Levitronix Bioprocessing Webinar brings industry professionals together to make a change.

Speakers: 

  • Samantha Cramer, Oakwood Labs, Formulations Engineer III, "Using Levitronix pumps in various unit operations of the microsphere manufacturing process"
  • Dr. Tizian Bucher, Dr. Mueller AG, R&D Engineer, "Cell Harvest using Cyclical Cake Filtration"
  • Thomas Herrmann, StemVac GmbH, Director Translational R&D and Manufacturing, "Trojan horses fighting cancer: The next level in oncolytic virus therapy"

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Friday, October 23rd, 2020

Speakers: Dejan Arzensek, Principal Scientist at Novartis and Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems

The discussion will be focused around the exploration of multiple techniques and their possibilities to secure tight control of the major critical quality attributes (CQA) and different PAT tools for measuring different attributes in real-time. A feasibility study of PAT tools covered in this talk demonstrates the technology for in-line measurements in fed-batch process steps and potential of their use in a continuous process.

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Monday, October 19th - Wednesday, October 21st

This Conference continues the ongoing tradition of addressing the opportunities and challenges, most relevant, to the future of microbiology in today's global market. Join new and seasoned professionals from all facets of the field, including global industry, academia, and regulatory authorities, to share insights on how to best prepare for the future through the sharing of best practices, development of standards, and integration of innovative technologies.

The comprehensive program agenda will include presentations from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology. 

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Tuesday, October 6th, 2020
Thursday, October 8th, 2020

In Part 2, we will review vaccine processes with examples based upon influenza vaccine, inactivated Polio vaccine and an overview of the different types of vaccine production processes from cell expansion, USP and DSP, to the formulation and filling operations to make the finished product. We will talk about vaccine production facilities, how equipment is integrated their operating principles and biological safety levels for containment. Finally, we will look at the vaccine industry today, the supply chain and globalization, and how important vaccines are in pandemic preparedness, availability, and time to market.

This is the second webinar in a series of 5 dealing with vaccine production. Part 1 will be available on demand.

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Tuesday, October 6th, 2020

Speaker: Dr. Mark A. Snyder, Manager, Process Chromatography, Bio-Rad Laboratories

Join our expert, Dr. Mark A. Snyder, to learn best practices and guidelines for successfully packing different types of chromatography resins. This includes incompressible resins like CHT Ceramic Hydroxyapatite Media as well as traditional compressible resins. CHT is an easy-to-use mixed-mode media and has high specific gravity, a rapid settling rate, and sensitivity to mechanical shear. These variations from traditional compressible resins have to be considered when designing CHT column-packing protocols. Attend this 15-minute webcast and get all your process column-packing questions answered.

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Wednesday, September 30th, 2020

Presenter: Olga Morejon Zayas, Head of PD, 3P Biopharmaceuticals

Process development is driven by designing processes for a wide range of expression systems in order to establish the appropriate process parameters that will result in successful scale up and robust cGMP manufacturing. In this webinar, Olga Morejón Zayas, Head of Process Development at 3P Biopharmaceuticals, will present the work on three experimental packages used to define the optimal process parameter to support high cell density culture of CHO DG44 cells to improve productivity and scalability. The presentation will include evaluation data on media and feed screening and optimization of feed strategies and process parameters. The results will highlight the value of the Ambr® 250 in the optimization of high cell density cultures and the relevance of the system for scalability and consistency of results.

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Wednesday, September 30th, 2020

Presenter: Jort Altenburg , Bioprocess Engineering, Wageningen University

To control the pandemic SARS-CoV-2 outbreak, rapid development of a COVID-19 vaccine is needed as well as serological tests to determine whether or not someone has contracted the virus and has built up immunity. The baculovirus-insect cell expression system can be used to produce the SARS-CoV-2 spike protein for vaccine and serological test applications. To produce sufficient amounts of spike protein in a relatively short period of time, rapid screening for optimal process conditions is of utmost importance.

Within this development of the Laboratory of Virology and the Bioprocess Engineering Group of Wageningen University, Applikon's micro-Matrix is used to screen different conditions for optimal cell growth and protein production in Sf9 cells. The micro-Matrix system allows for simultaneously performing 24 cultivations in a deep well plate with control of DO, pH and temperature. Therefore screening for optimal pH value can be done in a single experiment. Optimal conditions are also checked in Applikon's 500 mL miniBio (autoclavable bioreactor) and 500 mL AppliFlex ST (single-use bioreactor) and will eventually be scaled up to a 20 liter bioreactor, producing sufficient material for pre-clinical animal trials and serological testing.

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Wednesday, September 30th, 2020

Speaker: Dr. Letha Chemmalil, Principal Scientist, Bristol-Myers Squibb

This webinar highlights the application of Agilent 2D-LC with SegFlow automatic sampler for online monitoring and control of titer and critical product quality attributes (CQA) of monoclonal antibodies and fusion proteins. Other applications include, but are not limited to near-real-time amino acid quantitation and feedback control to maintain the homeostasis of cells in bioreactors. The integrated system is an enabling technology to fill the gap of current deficit in PAT to support QbD driven continuous bioprocessing. Continuous bioprocessing, referred as "Next Generation Manufacturing" is intended to achieve:

  • Increased product quality
  • Improved batch-to-batch reproducibility
  • Miniaturization of manufacturing footprint
  • Enhanced process understanding and robustness
  • Increased efficiency and flexibility
  • Reduced capital expenses and operating cost

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Wednesday, September 30th - Friday, October 2nd

We are pleased to invite you to join the upcoming 2020 Planova™ US Virtual Symposium. In lieu of our usual event, a virtual symposium will enable us to evolve safely to meet current COVID-19 challenges. The theme of the Planova Virtual Symposium is "challenging processes". This theme includes, among others, the following topics: continuous processing, challenging molecules and process conditions.

The challenges that we all face today with COVID-19 continue to define a new normal, and it is a reminder to the global community of the need for vigilance and cooperation. As we continue to learn how to best serve our communities, Asahi Kasei Bioprocess remains committed to enhancing the safety of biotherapeutic products.

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Thursday, September 24th, 2020

A centrifuge separates particles by density but do you know what type of centrifuges are used at the different steps of a bioprocess workflow and what are the important considerations? How contamination can jeopardize the integrity of the product and operator safe working conditions at each harvest, clarification, purification and concentration working step? Why scalability should be considered right at the R&D scale? What are batch traceability methods? And how to obtain the most uptime from your equipment.

This presentation will:

  • Review the bioprocess applications where the centrifuges play an important part.
  • Explore the importance of the contamination control, the scalability, the traceability and the reliability.
  • Discover the ways the centrifuge addresses these considerations in the bioprocess workflow by examining the data.

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Thursday, September 24th, 2020

The cell culture pilot plant at Genentech runs hundreds of E. coli fermentation experiments to help develop part of the company's pipeline. The pilot plant is a non-GMP facility that supports process development and evaluating new technologies that can be transferred into our manufacturing network. The E. coli experiments are continuously sampled every two hours, 24/7, resulting in approximately 20,000 E. coli samples a year. Evaluating an "at-line real-time analyzer" for E. coli fermentations that would be implemented to replace manual bench-top operations could significantly increase efficiency and improve data integrity.

In this GEN webinar, our panelists will describe their approach to evaluating the Cedex Bio/Bio HT analyzers for E. coli fermentation, and their impact on turnaround time and cost of analysis. The analyzer measures phosphate, acetate, ammonia, glucose, and optical density, as well as other parameters with high precision and accuracy for monitoring cell growth and metabolic levels for process development.

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Tuesday, September 22nd, 2020

Shakers and bioreactors are established versatile systems for cultivating microorganism, plant, and animal cells in suspension. Both methods aim at increasing the oxygen and nutrient supply in the medium to stimulate culture growth, but offer very different solutions in technique, volumes/throughput, control possibilities, and thus applications.

In this educational webinar, we will look at the biophysical background of both cultivation techniques, pros and cons, and areas of application. You will also learn how to optimize your process in shake flasks and bioreactors via proper choice of vessel type, vessel material, instrument configuration, and parameter settings. Additionally, we will introduce the use of feeding techniques bioreactors and have a glance on shakers too.

Learning Objectives:

  • Review: Why shake or stir cells and an outline of system specific differences
  • Learn how to identify the right cultivation method, vessel type, vessel material, and instrument configuration for your specific needs
  • Learn how to define and optimize important parameters to improve culture results - incl. Tips & Tricks
  • Learn about feeding possibilities in shake flasks & bioreactors and their impact on your culture  

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Tuesday, September 22nd, 2020

Raman spectroscopy is a process analytical technology for simultaneous in-line measurement of important process outputs in therapeutic protein production via mammalian cell culture, such as concentrations of key metabolites or even the protein being expressed. However, due to the complex and shifting nature of the various chemical species present in the cell culture system, Raman models will likely need to be at least partially trained on a process-specific basis. They must also be robust enough to maintain accuracy throughout the expected manufacturing process operational ranges.

This presentation is a proof-of-concept study to demonstrate a reliable Raman model can be developed in parallel with standard process development experimentation for later deployment in a scaled-up manufacturing process.

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Tuesday, September 22nd, 2020

Automated sampling in the Upstream Bioprocess has been around since the 90's but until recently, the technology had not reached a level that would move automated sampling from an early experiment to efficient way of decreasing the workload and reducing risks involved in manual sampling. And many are not aware of the full capabilities in automated sampling and how to get the most from the system. This webinar will talk about how to improve your bioprocess with next generation automated sampling systems designed to meet the sampling challenges. It will also touch on how Flownamics Seg-Flow performs automated sampling, the best practices for optimal Seg-Flow performance, and how to fully utilize the Seg-Flow's capabilities.

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Thursday, September 17th, 2020

Documenting studies on paper or Excel spreadsheets reduces efficiency and increases the chance of errors. The IDBS Bioanalysis Solution is a scientific informatics process execution system that supports all bioanalytical documentation needs - streamlining workflows in the lab and boosting compliance. The solution goes beyond traditional ELN and LIMS functionality, covering all aspects of the bioanalytical testing workflow, from ensuring method compliance to minimize deviations and errors and safeguarding data integrity, to easing the audit process and reducing the reporting time. 

In this demo, Craig Williamson, Solutions Consultant at IDBS, shows what the IDBS Bioanalysis Solution includes, what makes the configurable templates transformational, and how labs can benefit.

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Thursday, September 17th, 2020

Register now for our free panel discussion exploring current practises and challenges in the field of iPSC expansion and differentiation.

This panel discussion, featuring experts from institutions across the world, will focus on the variations in methods as well as the challenges faced by scientists in this field of research. It aims to assess the current state of the field by discussing the many different techniques used in iPSC differentiation and expansion and will consider how these processes may evolve in the future.

What will you learn?

  • The main techniques, technologies and materials currently in use
  • The current challenges faced in the differentiation and expansion of high-quality iPSCs
  • The future potential of iPSCs in therapies and other applications
  • How the technologies and techniques used to manufacture iPSCs may evolve

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Tuesday, September 15th, 2020
Thursday, September 17th, 2020

With multiple products on the market, gene therapy has now gone beyond proof of concept and entered mainstream healthcare. This success urgently requires work on manufacturing processes to ensure that gene therapies are widely available to all that need them. Furthermore, regulatory authorities, tasked with assuring quality, efficacy and safety of the final product, are placing increasing scrutiny on the manufacturing process. Regulatory guidance documents suggest that the risk of adventitious agent contamination should be assessed and mitigated through a risk-based approach.

In this webinar, we will outline key considerations in choosing the right technology for scale up in adherent and suspension cell cultures and some of the pitfalls that must be overcome to ensure success at large scale. Furthermore, we will detail a process control strategy to mitigate the risk of adventitious agent contamination.

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Wednesday, September 16th, 2020

Multiparticulate (MP) dosage forms provide opportunities to modulate drug release characteristics and target specific release sites within the GI tract. Fluid bed bottom-spray (Wurster) coating is routinely used to apply successive coating layers in the development and manufacture of these multiparticulate formulations.

In this webinar, experts in multiparticulate applications from Colorcon and Innopharma Technology will discuss how computational design and PAT can help build more robust formulations, predict multiparticulate performance, and accelerate development by reducing traditional iterative trial and testing practices in development.

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Monday, September 14th, 2020

Streamlining processes, ensuring consistency and risk reduction are widely sought objectives in the analytical laboratory. As sample volumes increase against fixed resources, especially in the contract market, service providers often turn to software to enable their people to meet these goals. The most effective solutions recognize the importance of direct integration of instrumentation with software to establish closed-loop, compliance workflows. With its latest product innovations, IDBS continues to find new ways to help R&D organizations capture, manage, and gain insights from their scientific and operational data. The company is excited to announce the release of a new integration component with SCIEX Analyst™, for both cloud and on-premise platforms of E-WorkBook.

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Thursday, September 10th, 2020

The BioProfile FLEX2 On-Line Autosampler (OLS) is a modular system that connects as many as 10 bioreactors to a FLEX2 analyzer for automated sampling and analysis of key cell culture analytes including pH, gases, metabolites, osmometry, cell density, and cell viability. The OLS' small sample volume and fast analysis time provide automated sampling and analysis of 10 bioreactors in less than 1.5 hours. Setup time for a full, 10-bioreactor system requires less than 20 minutes. With proven data comparability to manual sampling methods, the FLEX2 OLS can be connected to OPC-compliant control systems for automated sampling, analysis, and feedback control.

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Thursday, September 10th, 2020

The webinar focuses on applications within the pharmaceutical industry such as WFI and CIP processes. Practical examples will show how the SAW technology can be used to gain filling time, improve quality and reduce maintenance efforts. The audience will get to know how this new technology meets the highest hygienic standards. Since there is no sensor element in the tube, this design guarantees that the liquid is not contaminated, and the device supports hygienic cleaning processes. In addition, the flow sensor is able to measure several parameters; flow, temperature, density and detect any bubbles in the liquid at the same time.

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Thursday, September 3rd, 2020

In Hani's two-part webinar series, he will share data from recent research collaborations with UCL and NIBRT, exploring the impact of applying flow-through chromatography with nonwovens on clearance of soluble impurities, particularly Host Cell DNA. The research begins by investigating the impact of DNA removal prior to Protein A chromatography on the clearance of key problematic host cell proteins tracked using sophisticated LC-MS techniques. It will then show how DNA clearance during clarification can enhance the performance of Continuous Protein A Capture Chromatography. Building on the earlier webinars, these webinars are intended for new and experienced Process Development Scientists alike.

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September 2nd, 3rd, 9th and 10th, 2020

Data Integrity continues to be a major concern for Health Authorities and the pharmaceutical industry. Even though data integrity is a foundational requirement of all GXP regulations, there continues to be an increased focus on this topic both from a regulatory and industry perspective as data integrity breaches still drive a significant number of Health Authority enforcement actions such as Warning Letters, Import Alerts, product quarantines, and suspension or revocation of Marketing Authorizations.  Moreover, additional guidelines and regulations have been published to establish Data Integrity Standards.

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Tuesday, September 1st, 2020

Increasing demand for blood transfusions, but also safety towards emerging diseases of these call for new technologies to obtain red blood cells (RBC) for transfusion. Using cell culture techniques, erythroblasts, the precursor of RBCs can be proliferated at a small scale. For medical applications, a massive scale-up is required. Not only in volume but also cost-efficiency. Using engineering approaches, especially modeling and bioreactor cultivation systems, a significant increase in cell density and final cell titer were achieved.

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Tuesday, September 8th, 2020

The BioProfile FLEX2 On-Line Autosampler (OLS) is a modular system that connects as many as 10 bioreactors to a FLEX2 analyzer for automated sampling and analysis of key cell culture analytes including pH, gases, metabolites, osmometry, cell density, and cell viability. The OLS' small sample volume and fast analysis time provide automated sampling and analysis of 10 bioreactors in less than 1.5 hours. Setup time for a full, 10-bioreactor system requires less than 20 minutes. With proven data comparability to manual sampling methods, the FLEX2 OLS can be connected to OPC-compliant control systems for automated sampling, analysis, and feedback control. Explore this webinar to get a detailed picture of how the FLEX2 OLS can improve your cell culture analysis operation.

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Thursday, August 27th, 2020

In Hani's two-part webinar series, he will share data from recent research collaborations with University College London (UCL) and The National Institute of Bioprocessing Research and Training (NIBRT), exploring the impact of applying flow-through chromatography with nonwovens on clearance of soluble impurities, particularly Host Cell DNA. The research begins by investigating the impact of DNA removal prior to Protein A chromatography on the clearance of key problematic host cell proteins tracked using sophisticated LC-MS techniques. It will then show how DNA clearance during clarification can enhance the performance of Continuous Protein A Capture Chromatography. Building on the earlier webinars, these webinars are intended for new and experienced Process Development Scientists alike.

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Thursday, September 10th, 2020

The webinar focuses on applications within the biopharma industry such as WFI and CIP processes. Practical examples will show how the SAW technology can be used to gain filling time, improve quality and reduce maintenance efforts. 

The audience will get to know how this new technology meets the highest hygienic standards. Since there is no sensor element in the tube, this design guarantees that the liquid is not contaminated and the device supports hygienic cleaning processes. In addition, the flow sensor is able to measure several parameters (i.e. flow, temperature, density of the liquid) and detect any bubbles in the liquid at the same time. Best practice examples from our customers in the pharmaceutical industry will show participants how they could use such a new technology to improve the safety in their own production. We will also introduce a new flow measurement technology that improves the safety of flow measurement in the biopharma industry. Compared to conventional solutions the SAW (Surface Acoustic Wave) technology offers very precise measurements and highest levels of hygiene to improve the safety of the production, reducing time and space needed for installation and measuring several parameters at the same time.

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Tuesday, August 25th, 2020

Learn more about how ZETA's method for the determination of the kLa value provides a useful tool for optimization of the bioprocess.

Bioreactors should offer ideal conditions for the growth and product formation of microorganisms or cells. This is the prerequisite for optimal quality and maximum product yield. Designing a bioreactor for the optimum process is an enormous challenge. Knowing specific performance indicators -  like the kLa value - facilitates optimization of the bioprocess.

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Thursday, August 20th, 2020

Presenter: Masa Nakamura, PhD

Mammalian cell culture continues to be the workhorse for the expression of high-value therapeutic recombinant protein modalities. As requirements for manufacturing process performance, product quality and process safety become more stringent, cell shear during clarification has become a critical consideration for both preventing product degradation and designing clarification processes. In this webinar, Masa will present on cell shear mechanisms during clarification, the impact of cell shear on product quality and strategies to mitigate cell shear in depth filtration.

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Tuesday, September 8th, 2020 @ 8:00 AM EDT

Thursday, September 10th, 2020 @ 1:00 PM EDT

The BioProfile FLEX2 On-Line Autosampler (OLS) is a modular system that connects as many as 10 bioreactors to a FLEX2 analyzer for automated sampling and analysis of key cell culture analytes including pH, gases, metabolites, osmometry, cell density, and cell viability. The OLS' small sample volume and fast analysis time provide automated sampling and analysis of 10 bioreactors in less than 1.5 hours. Setup time for a full, 10-bioreactor system requires less than 20 minutes. With proven data comparability to manual sampling methods, the FLEX2 OLS can be connected to OPC-compliant control systems for automated sampling, analysis, and feedback control. 

Explore this webinar to get a detailed picture of how the FLEX2 OLS can improve your cell culture analysis operation.

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Wednesday, August 26th, 2020

Presenter: Andrew Lees, PhD
Founder and Scientific Director
Fina Biosolutions

In this brief webinar, Dr. Lees will present a case study on a purification process for rTTHc using polymeric chromatography resins. rTTHc was expressed at high levels as a soluble, properly folded intracellular protein in Fina Bio proprietary Escherichia coli strain. The protein has a molecular weight of 50 kDa with pI ~6. Multiple resins were screened using an automated chromatography system. Nuvia Q anion-exchange (AEX) resin (120 µm) was selected as the capture step and Macro-Prep Methyl hydrophobic-interaction chromatography (HIC) resin selected for polishing step. This two-step purification protocol was optimized for scale-up, resulting in >98% pure purified target protein.

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October 5th - November 6th, 2020

This 5-day professional short course will be delivered virtually over 5 weeks from October 5th - November 6th, 2020. The course will be taught by industry professionals from BMS, Pfizer, MilliporeSigma, and UMass experts.

The trainees will learn key principles and concepts of industrial bioprocessing of protein, cell and gene therapies. The course covers recent technologies and practices of upstream, downstream and analytical bioprocessing technologies. In addition, FDA initiatives of PAT (Process Analytical Technology), Quality by Design, and Emerging Technology will be covered. The course consists of 7 modules.

The audience for this course are individuals that are involved in manufacturing, product and process development, regulatory, QA/QC and of biotech therapeutics. Attendees from academia and regulatory agencies may also benefit depending on their areas of interest and level of experience.

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On Demand

We're excited to welcome you to our webinar on BioPAT® Spectro - unlocking the full potential of Raman spectroscopy in high-throughput process development and single-use biomanufacturing. In this webinar you will discover how BioPAT® Spectro enables ultimate process monitoring and control:

  • A new Raman spectroscopy platform that is integrated in the Ambr® 15, Ambr® 250 and Flexsafe STR® bags from 50L - 2000L

  • Scalable platform with standardized optical probe interface across Ambr® and Flexsafe STR® facilitates model transfer

  • Compatible with two leading providers of Raman spectrometers: Kaiser Optical Systems and Tornado Spectral Systems

  • Full integration in Ambr® including automated data acquisition and consolidation, automated spiking with stock solutions and contextualization of Raman spectral data with all process data by the Ambr® software

  • Fully integrated and qualified BioPAT® Spectro single-use port in Flexsafe STR® bags, which shields the measurement from ambient light, reduces set-up time, and decreases contamination risks.

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Thursday, August 6th, 2020

Presenter: Ethan Lovdal Butler, PhD

In this the second part of Ethan's two-part webinar series on the fundamentals of filtration, he marries a rigorous theoretical treatment of mass transport phenomena with practical application to clarification and sterilization processes used at biopharmaceutical companies every day. Based on his lectures at the Massachusetts Institute of Technology, Ethan starts with a broad overview of filtration terminology and then delves deeply into structure-function relationships, phenomenological modelling, bench-scale analysis and process-scale sizing. These webinars are intended for new and experienced process development scientists alike and will set the foundation for advanced topics discussed in later webinars.

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Wednesday, August 12th, 2020

Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, manual data transcription and all too frequently data gaps and data integrity challenges. This webinar discusses the difference between cleanroom classification and routine environmental monitoring, outlines the FDA 21CFR part 11 ALCOA guidance and shows how the new MET ONE 3400+ non-viable air particle counter from Beckman Coulter Life Sciences can automate routine environmental monitoring programs to help manage data integrity challenges.

Learning Objectives:

  • Why ISO 14644-1:2015 cleanroom classification sample locations should not be used for routine environmental monitoring of GMP cleanrooms
  • How the FDA 2018 updated guidance on 21CFR part 11 data integrity applies to GMP cleanroom routine environmental monitoring
  • How automating routine environmental monitoring SOPs inside the air particle counter itself to form interactive sampling maps helps to automate the process and reduce human error

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On Demand

Single-use technologies (SUT) have evolved into commercial operations and drug manufacturers look for solutions to industrialize its usage in a safe and reliable way. With single-use systems (SUS) adoption, quality ownership involves shared responsibilities between supplier and end user. Additional parts of the supply and quality chain shift to supplier. Join us as we present existing good practices to ensure critical quality attributes (CQAs) of the SUS throughout their life cycle.

In this webinar, the fundamental principles of Quality Risk Management (QRM) applied to SUS adoption and validation will be discussed. In addition, participants will gain an in-depth understanding of how to define an integrity strategy for their critical SUS, as well as on how to safely Pre-Use Post Sterilization Integrity Test (PUPSIT) filters in SUS. By the conclusion of the session, all attendees should be able to define a risk mitigation strategy for SUS.

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Presenter: Ethan Lovdal Butler, PhD

Thursday, July 30th, 2020

In Ethan's two-part webinar series on the fundamentals of filtration, he marries a rigorous theoretical treatment of mass transport phenomena with practical application to clarification and sterilization processes used at biopharmaceutical companies every day. Based on his lectures at the Massachusetts Institute of Technology, Ethan starts with a broad overview of filtration terminology and then delves deeply into structure-function relationships, phenomenological modeling, bench-scale analysis and process-scale sizing.  These webinars are intended for new and experienced process development scientists alike and will set the foundation for advanced topics discussed in later webinars.

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Presenter: Rahul Pradhan, Senior Scientist, Cell Culture Development at Kymab

On Demand

During this webinar Rahul Pradhan, Senior Scientist, Kymab, will present a case study on a manufacturing cell line screening campaign for a Kymab monoclonal antibody fusion protein. The data set obtained by the integration of the BioProfile FLEX2 with ambr 15 helped final cell line selection and process scale-up. The webinar will include examples of how to leverage the feedback loop between the FLEX2 and ambr 15 to allow the generation of a high-quality data set from multiple cell lines, including a full set of cell culture and metabolic profiles, something previously only possible with larger scale bioreactor systems.

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Presenter: Ethan Lovdal Butler, PhD

Thursday, July 30th, 2020

In Ethan's two-part webinar series on the fundamentals of filtration, he marries a rigorous theoretical treatment of mass transport phenomena with practical application to clarification and sterilization processes used at biopharmaceutical companies every day. Based on his lectures at the Massachusetts Institute of Technology, Ethan starts with a broad overview of filtration terminology and then delves deeply into structure-function relationships, phenomenological modeling, bench-scale analysis and process-scale sizing. 

These webinars are intended for new and experienced process development scientists alike and will set the foundation for advanced topics discussed in later webinars.

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Tuesday, July 21st, 2020

Over the past two decades, single-use process technologies have been increasingly incorporated into the manufacturing of biopharmaceutical products. Although the reasons for implementing single-use systems for bio manufacturing are compelling, some challenges and concerns related to their use remain. Single-use versus stainless steel - this discussion has been going on for many years. Each approach has its obvious advantages and drawbacks.

In this webinar, Roland Maichin, Head of Project Development at ZETA will illustrating case studies highlighting how challenges were overcome and which best-practice solutions have been developed to execute successful hybrid system projects.

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Enhancing the Future with Innovative Medicines and Manufacturing

Monday, July 20th - Wednesday, July 22nd, 2020

The theme of the 2020 meeting is Enhancing the Future with Innovative Medicines and Manufacturing. In selecting this theme, the planning committee designed a comprehensive event that encompasses the wide-ranging interests of all PDA members. Whether you are focused on improving existing processes or delving into entirely new technologies, the PDA Annual Meeting will cover relevant information important to small molecule, and biopharmaceutical, cell and gene therapy and other modalities.

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Tuesday, July 21st, 2020

This educational webinar covers the concept of upstream bio process scaling, the importance of design space and bioreactor engineering towards scalability, followed by case studies on the successful implementation of certain scaling approaches.

The webinar concludes with an introduction of a novel scale conversion tool used for scaling parameters in a bioreactor-size-independent way to predict the best set of cell culture parameters for single-use, stirred tank bioreactors from development through to manufacturing scale.

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Tuesday, July 21st, 2020

Over the past two decades, single-use process technologies have been increasingly incorporated into the manufacturing of biopharmaceutical products. Although the reasons for implementing single-use systems for bio manufacturing are compelling, some challenges and concerns related to their use remain. Single-use versus stainless steel - this discussion has been going on for many years. Each approach has its obvious advantages and drawbacks.

Why not combine both worlds - single-use AND stainless steel - and benefit from the resulting hybrid technology? ZETA is a global pioneer in the engineering of SU/SS hybrid systems and has a track record of successful projects.

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Tuesday, July 14th, 2020

In this webinar, Pall will present case studies illustrating the benefits of leveraging industry experts, proven methods, and integrated upstream solutions to design a robust, scalable and reproducible process. What does it take to get a new biotech drug to market? The process development starts with culturing cells and requires the right technology to reliably and efficiently produce them. The capability to seamlessly move out of process development, into clinical trials, and from small to large-scale cGMP manufacturing, is essential.

Participants will learn:

1. Strategies for transferring scalable processes from pre-clinical to cGMP commercial manufacturing

2. How partnering with Pall's Accelerator process development services team will help reduce time to market

3. Innovative single-use bioreactors whether you are growing adherent or suspension cells

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Wednesday, July 15th, 2020

Everyone working with cultured cells experiences contamination at some point. Contamination by microorganisms, other mammalian cells, and volatile organic chemicals is a recurring problem in basic and applied research as well as in production of therapeutic and other biologic products. Statistics show that contamination is much more prevalent than most researchers acknowledge. Even a single contamination incident can cost significant time and money and threaten the reputation of an investigator, laboratory or product.

This presentation will:

  • Review the different types of cell culture contamination and their effects on cells.

  • Explore the ways in which contamination occurs and offer advice for preventing contamination occurrences, including some steps that few labs take on a routine basis.

  • Compare methods for contamination control in the CO2 incubator--the central equipment for cell growth--and differentiate options with efficacy data.

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Wednesday, July 8th, 2020

The world is expecting a COVID-19 vaccine in 2021. To meet this aggressive timeline, vaccine manufacturers will not have time to build dedicated facilities: the first generation of COVID-19 vaccine will rely heavily on single-use technologies to ensure rapid installation and validation of new production lines, and existing facilities will be adapted to accommodate the production of the billions of needed doses. Under such a time pressure, how can vaccine developers take the right decision and mitigate risks when it comes to equipment sizing, technology selection and layout considerations? 

The presentation will explain why it is critical to put the process at the center of all decisions; and also show different approaches in cases where processes are not fully defined and scenarios where different processes and/or scales need to be executed in the same facility. Experiences from multiple projects will be shared.

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Tuesday, June 30th, 2020

Data integrity is the extent to which all data are complete, consistent and accurate throughout the data lifecycle. It is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. 

Data integrity arrangements must ensure that the accuracy, completeness, content and meaning of data is retained throughout the data lifecycle. Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and data disposal after the record's retention period ends. System design and controls should enable easy detection of errors, omissions, and unexpected results throughout the data's life cycle.

In this webinar, data integrity requirements for filter integrity test instruments will be discussed and demonstrated, with specific focus on: static electronic record, electronic audit trail of relevant GMP parameters, access control, data backup and data transfer.

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Tuesday, June 30th, 2020

Leaders in the biopharma industry are continuing to invest heavily in Raman spectroscopic technology in the quest to convert data into value. With nearly infinite possible combinations of data which can be collected for any given process, the challenge lies in identifying the small fraction of those which can ultimately produce valuable returns on the investments needed to capture the data, and in executing upon those correctly. Faced with this quandary, many scientists and engineers at large firms are understandably risk averse about recommending a new technology investment.

This webinar will present: 

  • An overview of the quantifiable value proposition and key applications of Raman Spectroscopy in the biopharmaceutical industry
  • Illustrations of Raman technology in action using customer-proven solutions and real-world case studies from leading biopharma companies
  • An overview of the Kaiser Raman spectroscopy solution suite including analyzers, probes, and services
  • How to set realistic expectations, understanding that even the most well-developed solutions may or may not provide the returns you need to justify the investment for your specific company, but conversely, that your firm's capabilities (and ROI) is not limited to published data... it could, in fact, be even greater.

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Wednesday, June 24th, 2020

Vaccine pipelines are evolving to be more diverse and are requiring the use of different cell lines and virus types.  As the products vary, the manufacturing modes, process analytical needs, and volume requirements change along with the regulatory landscape.  The need for scalable, flexible, and single-use process development tools and manufacturing strategies are becoming increasingly important. 

This webinar will highlight using Ambr®️ 15, Ambr®️ 250, Biostat RM, and Biostat STR along with integrated process analytical technologies (PAT) to go from high throughput process development to an intensified seed train and manufacturing platform. Vaccine specific case studies will be shown for the Ambr®️ 15 and Ambr®️ 250 looking at different suspension and adherent cell lines.

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Wednesday, June 24th, 2020

Many companies have asked employees to work from home for their safety and well-being, but relying on manual sampling to collect data doesn't give you many options. Your work is in the lab, taking samples several times a day, sometimes even at night or on weekends. Join us to know more about the next generation of the industry-leading Flownamics Seg-Flow Automated Sampling System, the Seg-Flow S3, a solution designed and built for the most critical sampling applications and challenges.

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Wednesday, June 24th, 2020

The goal of the homogenization process in a bioreactor is to maximize the biological productivity, which can only be guaranteed under ideal mixing conditions. Magnetic mixing technology stands out with its many advantages compared to mechanically sealed agitators. The decision to replace conventional stirrers with magnetic mixers paves the way to reduce the contamination risk during the bioprocess, to lower production costs, and to make the equipment easier to clean. ZETA not only supplies magnetic mixers for new bioproduction plants, but also supports the retrofitting of existing bioproduction systems by providing suitable magnetic agitators and helping with their installation, operation and maintenance.

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Wednesday, June 24th, 2020

In this presentation, we will demonstrate an integrated mAbs downstream purification process to enable significant throughput improvement while removing of critical impurities. The process approach includes (1) pre-absorption filtration technology and (2) buffer additives. Through use of pre-absorption filtration technology, in combination with PROchievA protein A affinity resin, that possess high dynamic binding capacities of greater than 60 g/L, we have obtained antibodies with increased purity, while reducing overall process time.

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Thursday, June 18th, 2020

Data analytics are powerful tools which can be used to maximize process data from development to manufacturing. In this webinar we will cover how to use data analytics to simplify process scale up and facilitate technology transfer.

Key Messages from the Webinar:

  • Scale up processes can be optimized using data analysis

  • Risks associated with tech transfer can be mitigated using data analysis

  • Once you reach commercial production real-time analytics decreases risk of failure and ensures product quality and manufacturing success

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Wednesday, June 17th, 2020

The increasing number of sophisticated molecules entering today's biologics-development pipeline can pose purification challenges during process development in the biopharmaceutical industry. Join Dr. Mark Snyder as he discusses scalable purification strategies from capture to polishing of these biomolecules. Case studies to design robust purification methods and increase overall bioprocessing efficiencies will be presented.

Topics Include:

  • Hydrophobic anionic exchange mixed-mode resin, Nuvia aPrime 4A, designed for the purification of the diverse and expanding biotherapeutics
  • Calcium affinity cation exchange mixed-mode media, CHT XT, fine-tuned for superior removal of aggregates and process impurities and virus purification
  • High performance strong anion exchange resin, Nuvia HP-Q, engineered for large biomolecule purification like plasma proteins IgA and IgM, viruses and VLPs 

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Tuesday, June 16th, 2020

This 20 minute mini-webinar will discuss how YMC have adapted our Stainless Steel Twin Column Chromatography systems to operate within a single use facility. Graphics and discussions will include the enabling single use devices which allow the handshake between gamma irradiated, single use feed, buffer, and collection vessels/tubing, to a robust Stainless system which has been sanitized using NaOH. We will also include information on the automated sequences and piping design that ensures complete sanitization of all SS wetted surfaces. There will also be some forward looking information on other methods of sanitization using Ozone gas and the advantages this would have over caustic.

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NOTE: This is one in a series of ~15 webinars on twin-column "continuous" chromatography technology by YMC/ChromaCon. View all on www.biowebinar.com search term "YMC".

Tuesday, June 16th, 2020

Single-use systems are increasingly used in the manufacture of vaccine platforms as they offer ready-to-use solutions with proven quality performances, extended functionalities and operational benefits. The different virus platforms (recombinant protein, virus, viral vector or mRNA) provide new challenges for the implementation of single-use systems. 

This webinar will present how QbD and application information have been implemented for designing the SU solutions and their quality features. With the increasing need of patient and operator safety, the presentation will focus on risk analysis and mitigation action in place for standard single-use systems for storage, mixing and shipping steps. The Pre-Designed Solutions offer robust bioprocessing, reliable quality performances as well as reliable supply chain and business continuity well adapted to the needs of the different vaccines platforms.

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Thursday, June 11th, 2020

If you are working in the Biopharma industry, you are already well acquainted with the tremendous benefits it brings to the world. However, the design, development and delivery of biopharmaceutical products can pose stiff challenges for the industry. Sometimes these challenges simply lead to frustration; while at other times, they can have costly consequences. 

The Masterflex® panel with over 80 years of combined Fluid Handling experience will provide you with the tools and guidance to help all Biopharma professionals:

  • Gain time & save money using remote access technology
  • Adapt to new workplace safety guidelines
  • Maximize production through single-use solutions

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Wednesday, June 10th, 2020

As the world searches for a way to end the coronavirus pandemic, government bodies, academic collaborations and pharma companies race to produce effective new therapies and vaccine candidates for COVID-19 With more than 115 companies actively engaged in this endeavour, we see approximately 10% of these vaccine candidates focused on viral vaccine expression systems. Speed to clinic is of paramount importance; however, as producing a commercial vaccine can take many years, how can we accelerate vaccine development with speed and safety in mind? 

To meet these challenges in a pandemic situation, you can benefit from our rapid platform approaches to cell line and virus seed testing; our media manufacturing network, and our scalable single-use process solutions and process monitoring tools to simplify progression and ensure rapid release of your drug product.

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Thursday, June 11th, 2020

Research on exosomes and other forms of extracellular vesicles (EVs) have rapidly expanded over the last two decades. These lipid-enclosed, nanoscale messengers are released from cells packed with diverse cargo and can travel long distances to modify the function of target cells. Found in abundant quantities in biological fluids like blood, there is great clinical interest in using EVs as diagnostic markers or altering their properties for therapeutic delivery. Tune in to find out more about what exosomes are, how researchers study them, and what challenges remain. This talk will highlight multi-laser nanoparticle tracking analysis (NTA) with the ViewSizer 3000 and what it offers in exosome research.

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Thursday, June 11th, 2020

Laboratory scale process characterization provides in-depth process understanding and documentation of a manufacturing process needed to establish critical product and process parameters, determine proven acceptable control ranges and minimize the risk of manufacturing failures at production scale. Here we present process development and characterization strategies at Samsung Biologics required to support commercial scale manufacture of antibody therapeutics. 

The webinar will discuss approaches to demonstrate process understanding needed to develop a robust and scalable manufacturing process to support successful GMP manufacture of biologics. 

Speakers:

Kenneth Dawson Green, PhDSenior Director, Manufacturing Science & Technology Team

Thomas Rene Gervais, PhDDirector, Manufacturing Science & Technology Team - Downstream

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Thursday, June 4th, 2020

This webinar focuses on the essentials of pH measurement in a bioprocess. Measuring pH is one of the most common and routine types of analysis. But achieving good precision and accuracy requires following proper techniques. When implemented consistently across a team, efficient and effective management of pH offers significant benefits.

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Tuesday, June 9th, 2020

In a joint collaboration, Oxford Biomedica and Repligen increased the yield of viral vectors from suspension-cultured bioreactors several fold using tangential-flow depth filtration (TFDF). The yield for a single clarification step was 95% as compared to 70% by standard depth filtration. The TFDF tubular format and low shear enabled further yield increases through multiple harvests from the same seeding. A single seeded bioreactor produced two harvests of 95% and 85%. The 180% yield represents a 2.5-fold increase over a single depth-filtration harvest at 70%.

The process was shown to scale from 5 L to 50 L with an average flux of 750 LMH and three different lentiviral model systems, demonstrating broad applicability. Logistics and execution required a single filter, three AseptiQuik connections, and typically 15-20 minutes for setup and breakdown, resulting in a four-fold reduction in required footprint as compared to conventional depth filtration.

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Wednesday, June 3rd, 2020

Presented by Dan Hill, Biogen

The use of in-line Raman spectroscopy as an in-line process analytical technology (PAT), in the biotechnology industry, has matured over the past decade from a technology with promise to a standard tool for real-time, continuous monitoring of cell culture processes. There is an ever-growing body of work demonstrating successful application from metabolite and product quality monitoring to process control in both process development and GMP manufacturing environments. This presentation will describe Biogen's past efforts and strategic direction as it relates to in-line Raman spectroscopy for cell culture operations and how we intend to leverage its capability beyond metabolite monitoring and glucose feedback control to become an essential element of our Advanced Process Control efforts.

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Wednesday, June 3rd, 2020

Presented by Vincent Wiegman, University College London

The recent clinical success of several CAR-T cell therapies has led to a rise in research endeavours into every part of their manufacturing. Timelines are critical and the final product is extremely high in value, which emphasises the need for an efficient and dependable process. This webinar shows how the micro-Matrix system can be used to optimise the environmental conditions of the T Cell expansion step and it explores the impact of varying CO2 conditions on T Cell proliferation in single-use stirred miniature bioreactor systems.

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Tuesday, June 2nd, 2020

In this webinar we will cover techniques in data analytics for accelerating vaccine discovery and development. These techniques are designed to surface trends and actionable insights across a wide range of data sets to alleviate the burden researchers and developers face as they look for clues that will speed up vaccine development and identify effective treatments.

Relevant methods and use-cases covered in this webinar include:

MODDE®️ and Design of Experiments (DOE)
SIMCA®️ and Multivariate Data Analysis (MVDA)

This Webinar is aimed at those working in R&D as well as leaders responsible for looking for ways to accelerate vaccine discovery and development. 

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Wednesday, May 27th, 2020

Rapid progress in biotechnology and the ever-increasing complexity of medicines presents bioprocessing with significant challenges. Novel technologies such as single-use and continuous manufacturing are revolutionizing industry processes.

Speakers: 

Markus Brakel, Boehringer-Ingelheim Pharma GmbH & Co.KG, Senior Scientist Upstream Development«Optimization of Buffer Exchange in N-1 Perfusion»

Cédric Schirmer, ZHAW Zurich University of Applied Sciences, Research Associate«Shear Stress Investigations on Levitronix Single-Use Centrifugal Pumps»

Martin Glenz, Pall Biotech, Principal Scientist«mPath™ IoR Concentration Monitor»

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Tuesday, May 26th, 2020

In this live webinar, Jahir Kololli, the senior product manager for Hamilton's Arc intelligent sensors portfolio, shares the reasons behind the industry shift from polarographic to optical-based dissolved oxygen measurement. Further, he discusses common challenges with optical DO measurement and how those challenges are addressed with the latest generation of sensors.

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Thursday, June 11th, 2020

Research on exosomes and other forms of extracellular vesicles (EVs) have rapidly expanded over the last two decades. These lipid-enclosed, nanoscale messengers are released from cells packed with diverse cargo and can travel long distances to modify the function of target cells. Found in abundant quantities in biological fluids like blood, there is great clinical interest in using EVs as diagnostic markers or altering their properties for therapeutic delivery.

Tune in to find out more about what exosomes are, how researchers study them, and what challenges remain. This talk will highlight multi-laser nanoparticle tracking analysis (NTA) with the ViewSizer 3000 and what it offers in exosome research.

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Thursday, May 21st, 2020

The current manufacturing processes for viral vectors for gene therapy, which we can define as Gene Therapy Manufacturing 1.0 (e.g., adherent cell culture and transient expression from plasmid transfection), are not productive enough to meet the future demand considering the quickly increasing number of approved gene therapies and clinical trials. A transition is therefore ongoing to implement more productive and scalable processes, leading to Gene Therapy Manufacturing 2.0 using suspension cell culture and developing producer cell lines. Adopting the right technology solutions on this journey is essential.

In this talk we will:

  • Evaluate the near-future needs for gene therapy manufacturing

  • Discuss the major technology challenges posed to quickly develop high-productivity, -safety, and -quality manufacturing processes for viral vectors

  • Propose technology solutions for upstream (perfusion cell culture) and downstream (tangential-flow filtration and chromatography) processing to overcome these challenges.

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