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Event Alert | Aspen Xchange

Event Alert

Wednesday, February 24th, 2021

Thomas Müller-Späth, Ph.D, CTO at YMC ChromaCon AG

For RNA and similar therapeutics, the application of twin-column HPLC systems enabled with the innovative MCSGP* approach is proving significant process time savings coupled with increase in yield. This webinar will present new data from purification studies using RNA drug precursors. The MCSGP technology will be briefly explained and then data from recent purification studies will be reviewed. In one case, the use of twin-column chromatography improved yield by +40%, allowing to produce 70% more product with the same feed material input, shorten production campaign time by 40%, or downsize upstream synthesis by 40%. *Multi-column Counter-current Solvent Gradient Purification
Learn More

Thursday, February 11th, 2021

Zoltan Gulyas
Field Applications Specialist
Thermo Fisher Scientific

Affinity chromatography is a powerful purification technique that has proven its success in multiple areas of biotherapeutic manufacturing from monoclonal antibodies to AAV viral vectors for gene therapy applications. The selectivity of the affinity ligand ensures high purity and yield in a single step and can be the basis of a purification platform for rapid development of similar molecules in the pipeline. Despite these benefits, implementation of affinity chromatography in vaccine production has rarely been realized in the past. Join this webinar to understand how affinity chromatography can aid vaccine development and manufacturing, and learn more on novel solutions that can help to improve the purification of different vaccine modalities such as mRNA and protein subunits.
Learn More

Thursday, February 18th, 2021

Holden Harris, Associate Director of Quality Systems, FUJIFILM Irvine Scientific

Join us for an exciting new webinar led by our Associate Director of Quality Systems, Holden Harris. Harris will be sharing a behind the scenes look into our assisted reproductive technology (ART) media development process, providing insight into work done during product design and testing during design control. Attend the session to gain a closer look into how we ensure our media meet rigorous quality, safety, and performance criteria before going to market.
Learn More

Wednesday, February 3rd, 2021

Kerstin Lange, Andrew Falconbridge at Alvotech 
Earl Pineda Sr. Manager, Upstream Field Applications EU/APAC from Repligen

Alvotech developed an intensified fed-batch process using a cell retention device for the production of a complex fusion protein. The process uses the novel technique of High Productivity Harvest (HPH), which involves a traditional FB process and a clarification process using a cell retention device. Implementing the new process resulted in higher vcd and viability, improved product quality, and a reduction of cost of manufacture compared to the conventional fed-batch process.
Learn More

March 15th - March 17th, 2021

Online

This premier conference will offer a new format, new pricing, and new ways to connect! What will remain constant is that this Conference will highlight what’s in store for the future of pharmaceutical manufacturing. Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes.
Learn More

Tuesday, February 2nd, 2021

Kenneth Thompson, PhD
Manager, R&D, Cell Biology
Thermo Fisher Scientific

In this GEN webinar, the presenters will highlight upstream and downstream solutions across the AAV production workflows. Specifically, we will learn about scalable, high-titer AAV production in two cell host systems: a helper free 293F-based suspension system and the insect-cell based ExpiSf™ Expression System. Additionally, we will hear about the benefits of utilizing a specifically engineered affinity chromatography resin in the downstream purification of AAV, which can significantly improve viral clearance. Finally, our panel will focus on the regulatory requirements for safety and purity testing during the AAV production process, as well as discuss the benefits of implementing automated systems to save time and demonstrate product quality and safety.
Learn More

Tuesday, February 16th - Friday, February 19th, 2021

This online virtual training course will provide a detailed understanding in upstream and downstream processing of viral vectors used in cell and gene therapy. The course will focus on viral vector theory, technical demonstrations of bioreactors, demonstration of chromatography, principles of tangential flow filtration (TFF) and scale-up topics.
Learn More

Tuesday, February 9th, 2021

Kelly Flook, PhD
Senior Product Manager, Purification, Bioproduction Division, Thermo Fisher Scientific

Affinity chromatography, a highly scalable method, has earned its credits in the development of biologics such as the use of Protein A for the purification of therapeutic antibodies and more recently, anti-AAV resins in gene therapy workflows. An effective affinity purification step can help to simplify biomolecule downstream processing, reduce the number of purification steps, and reduce the overall cost of goods in bio-therapeutic manufacturing. To support the development of mRNA-based therapies, we have developed a new affinity resin for the purification and isolation of mRNA from in vitro transcription (IVT) manufacturing processes. This webinar will provide an overview on how this resin can help to maximize efficiency and simplify the mRNA purification process.
Learn More

Wednesday, January 27th, 2021

Buffer preparation is still a highly manual activity in the biopharmaceutical industry that often requires a lot of resources due to the large number and overall volume of buffers and process liquids used in a typical bioprocess workflow. Most companies are still relying on the traditional ways of preparing buffers, but there are more modern, alternative buffer preparation methods that can bring significant savings and efficiency improvements while ensuring high quality.
Learn More

Wednesday, January 27th, 2021

Matt Clifford, Senior Product Manager IDBS

Automation and parallelization are creating more data that teams sift through, often manually, to make decisions against. To achieve this, scientists are adopting compensating behaviours and making decisions partly based on prior outcomes. This is called “outcomes bias”; it is the equivalent of running a red light getting to work to cut the time of your commute, then making running red lights your daily commuting strategy for the next year and assuming it will always turn out the same! The way out of this common trap is to be able to be transparent on what data was used to make a decision, and to make sure the team have easy access to data, so collectively you can measure the quality of the decision and the outcome. IDBS has created a new product offering to address this need for scientists in high throughput biologics research and development.
Learn More

Wednesday, Januar 27th, 2021

Matt Clifford, Senior Product Manager, IDBS

Automation and parallelization are creating more data that teams sift through, often manually, to make decisions against. To achieve this, scientists are adopting compensating behaviours and making decisions partly based on prior outcomes. This is called “outcomes bias”; it is the equivalent of running a red light getting to work to cut the time of your commute, then making running red lights your daily commuting strategy for the next year and assuming it will always turn out the same! The way out of this common trap is to be able to be transparent on what data was used to make a decision, and to make sure the team have easy access to data, so collectively you can measure the quality of the decision and the outcome. IDBS has created a new product offering to address this need for scientists in high throughput biologics research and development.
Learn More

Monday, January 25th, 2021

Duncan Borthwick, PhD, Global Marketing Manager Solentim Ltd.,
Mark Stockdale, Amalgamator of Business and Biology, Galvanize Bio

This informative webinar, market leader Solentim will introduce two new products, an instrument named ICON™, that is designed to empower laboratories to make better decisions faster, and an over-arching software platform called STUDIUS™. Attendees will learn about how these two new products work to provide a new data-driven workflow for the development of modern cell-based therapies. Participants will be hearing from Solentim’s R&D and biology groups alongside cell line development experts in this first insight into Solentim’s new products. Register for this webinar to view the presentation, with the opportunity to ask the development team about the capabilities of these new systems.
Learn More

Tuesday, February 2nd, 2021

Tobias Zipf, Product Manager
Andrew Lamore, Field Segment Manager – Hygienic Bürkert

The market demands on components and systems are high: fast, simple commissioning, ease of maintenance, simple integration of safety functions, highest possible software integration into higher-level control systems or DCS systems and, of course, process safety are just a few examples. Find out which solutions can help you with these requirements to create safe and efficient production processes and thus save time and money.
Learn More

Wednesday, February 3rd, 2021

The Cell Therapy Summit is a free, half-day virtual event that brings together the global community of cell therapy researchers, developers, and manufacturers to discuss key achievements, common challenges, and advanced solutions for the industry.
Learn More

Tuesday, February 16th - Friday, February 19th, 2021

This online virtual training course will provide a detailed understanding in upstream and downstream processing of viral vectors used in cell and gene therapy. The course will focus on viral vector theory, technical demonstrations of bioreactors, demonstration of chromatography, principles of tangential flow filtration (TFF) and scale-up topics.
Learn More

Thursday, January 21st, 2021

Julia Hupfeld - Scientist - PD Membrane and Beads Applications,  Sartorius

In this webinar, Julia Hupfield will present data on how T-cell expansion can be easily established in stirred-tank bioreactors using the Ambr®15 Cell Culture for early process development. The Ambr15 in combination with DoE provides the capability to screen and optimize process parameters at the small scale and with high throughput operation in a time- and cost- efficient manner.  The critical process parameters identified can then be used to define process settings at larger scale.
Learn More

Tuesday, February 9th, 2021

Kelly Flook, PhD, Senior Product Manager, Purification, Bioproduction Division, Thermo Fisher Scientific

Affinity chromatography, a highly scalable method, has earned its credits in the development of biologics such as the use of Protein A for the purification of therapeutic antibodies and more recently, anti-AAV resins in gene therapy workflows. An effective affinity purification step can help to simplify biomolecule downstream processing, reduce the number of purification steps, and reduce the overall cost of goods in bio-therapeutic manufacturing. To support the development of mRNA-based therapies, we have developed a new affinity resin for the purification and isolation of mRNA from in vitro transcription (IVT) manufacturing processes. This webinar will provide an overview on how this resin can help to maximize efficiency and simplify the mRNA purification process.
Learn More

Monday, January 25th, 2021

Duncan Borthwick, PhD, Global Marketing Manager, Solentim Ltd
Mark Stockdale, Amalgamator of Business and Biology, Galvanize Bio

In this informative webinar, market leader Solentim will introduce two new products, an instrument named ICON™, that is designed to empower laboratories to make better decisions faster, and an over-arching software platform called STUDIUS™. Attendees will learn about how these two new products work to provide a new data-driven workflow for the development of modern cell-based therapies. Participants will be hearing from Solentim’s R&D and biology groups alongside cell line development experts in this first insight into Solentim’s new products. Register for this webinar to view the presentation, with the opportunity to ask the development team about the capabilities of these new systems.
Learn More

Wednesday, January 20th - Thursday January 21st, 2021

Are you compliant with FDA requirements for CSV, Data Integrity & Process Validation? Today's regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes through a drug product's cycle. That is why you cannot afford to miss Pharma Ed's CSV, Data Integrity & Process Validation Virtual Summit. This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.
Learn More

Thursday, January 14th, 2021

Amanda Suttle, Research Scientist
Dr. Ma Sha, Head of Bioprocess Applications
Rich Mirro, Business Manager, Eppendorf

In this webinar we showcase scale-up of an antibody production process in CHO cells from bench to pilot/production scale. We discuss strategies to prepare seed cultures of reproducible quality in shake flasks. We demonstrate a new concept for software-aided scale-up strategy design, which considers vessel parameters of differently sized Eppendorf BioBLU® Single-Use Vessels and Thermo™ HyPerforma™ Single-Use Bioreactors
Learn More

Tuesday, January 12th, 2021

Dr. Alex Esmon, SBS General Manager, Cold Storage at Thermo Fisher Scientific

The right freezer for storing your vaccine. Find out quickly what type of freezer you need and how many doses of vaccine fit into it. A vaccine is only as good as the solution used to store it, as many require highly specific temperatures to remain effective. Any deviation from this can have a dramatic impact on a vaccine’s viability and, at worse, render it useless. The WHO estimates that more than 50 percent of vaccines may be wasted globally every year due to temperature control, logistics and shipment-related issues. For our part, Thermo Fisher Scientific strives to provide vaccine distributors, hospitals, doctor’s offices and pharmacies with the tools they need to deliver every vaccine at full strength and efficacy – and that starts with the right cold storage.
Learn More

On Demand

Christopher Murphy
Vice President/General Manager, Viral Vector Services/Pharma Services Group
Brandon Pence
Vice President / General Manager, Purification and Pharma Analytics
Chris Williams
Vice President/General Manager, Single Use Technologies
Thermo Fisher Scientific

During this round table discussion, our panel of experts will provide insights on challenges facing the industry and how they impact success. They will also speak to the future vision for vaccine and biotherapeutic manufacturing, and how Thermo Fisher Scientific can help to accelerate delivery in the battle against SARS-CoV-2. 

Learn More

On Demand

Stuart Tindal - Product Manager: Flexact Platform 
David Johnson - Head of Chromatography Systems

As our serviced industry seeks rapid process development and intensification to service its expanding competitive market, we are looking at how the recently acquired chromatography & tangential flow technologies merge with a flexible multifunctional bioprocessing separation platform. Additionally, we describe the cost effective benefits of imbedding data analysis packages, harmonized smarter single-use sensors, actuators and sustainable plastic fluid management technologies over this downstream and liquid processing platform.
Learn More

January 19th - 21st, 2021

As we celebrate our 20th year, we are excited to offer a fully integrated virtual event that will continue to serve as a content hub for the latest research and biotherapeutics developments, provide a 1:1 networking platform, offer an interactive exhibit hall, live Q&A sessions, breakout groups, research posters, and so much more.
Learn More

January 11th - 13th, 2021

Speakers:
Wenzhen Huang - UMass Dartmouth
Bharatendra K Rai - Mass Dartmouth
Seongkyu Yoon - UMass Lowell

This course teaches the basic statistical principles, state-of-the-art concepts, advanced tools, and available techniques for statistical process monitoring, quality fault detection, and continues improvements for wide variety of applications including biomedical and pharmaceutical manufacturing applications.
Learn More

On Demand

The vaccine and biotherapeutic manufacturing industries are under pressure to address critical challenges of speed, scale, and supply in its response to SARS-CoV-2. What does this mean for technologies enabling production and how does this impact the future of vaccine and biotherapeutic manufacturing? During this round table discussion, our panel of experts will provide insights on challenges facing the industry and how they impact success. They will also speak to the future vision for vaccine and biotherapeutic manufacturing, and how Thermo Fisher Scientific can help to accelerate delivery in the battle against SARS-CoV-2. 
Learn More

On Demand

Stuart Tindal, Product Manager, Flexact Platform

As our serviced industry seeks rapid process development and intensification to service its expanding competitive market, we are looking at how the recently acquired chromatography & tangential flow technologies merge with a flexible multifunctional bioprocessing separation platform. Additionally, we describe the cost effective benefits of imbedding data analysis packages, harmonized smarter single-use sensors, actuators and sustainable plastic fluid management technologies over this downstream and liquid processing platform.
Learn More

Monday, December 21st, 2020

Jon Van Pelt, GM, Bioprocess Single Use & Enterprise Solutions

On December 21st, 2020, Cytiva will officially open its new 80,000 square foot manufacturing facility in Shrewsbury, Massachusetts! Join our #LinkedInLive broadcast as Mary Blenn, Vice President, Global Supply Chain, Jon Van Pelt, General Manager, BioProcess Single Use & Enterprise Solutions, and Anita Desai, Site Human Resources Manager, discuss the facility’s accelerated build-out and how it will help our customers develop live-saving therapeutics for patients around the world. 
Learn More

Monday, December 21st, 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.
Learn More

Wednesday, December 16th, 2020

Michael Burns, Senior Engineer, MilliporeSigma

When COVID-19 started to spread across continents and become a global pandemic, biopharma manufacturers around the world faced two major challenges: (1) enter the race for treatment of the disease by participating in vaccine development and (2) avoid delays in the production of other essential therapeutics. This video webinar presents two case studies from Europe and Latin America that demonstrate how the global teams across the M Lab™ Collaboration Center network used innovative remote technologies to overcome these challenges and meet important production timelines. 
Learn More

Tuesday, Tuesday 15th, 2020

Antibody-drug conjugates (ADC) are complex therapeutics with multiple components, all of which require specialized teams of scientists. The field has evolved significantly over that last decade as lessons learned and novel innovations have led to increased clinical success. Yet, as more innovators join in the search for cures, competition increases as companies chase first-to-market milestones and best-in-class therapeutic status. Increasingly and to gain traction quickly, innovators look to outsource one or more aspects of production across the complex supply chain. However, the choices in outsourcing have their own challenges. In this webinar, we will discuss ADC therapeutic market trends and technology advancements and how those trends relate and impact the selection of the optimal development and production partner.
Learn More

Webinar

Thursday, December 10th, 2020

This webinar will explore how single-use systems can be integrated fully into a process to allow Pre-Use Post Sterilization Integrity Testing (PUPSIT) for sterilizing-grade filtration and filling of medicinal product. Thus simplifying changeover between batches, eliminating the need for time-consuming and costly CIP /SIP and reducing the risk of contamination. We will review PUPSIT principles and outline key considerations for SUS implementation including aseptic transfer into the Grade A space, surge vessel design, supplier responsibilities and important validation tests such as particulates and system leak/integrity testing.
Learn More

Tuesday, December 8th, 2020

Dirk Muller, Manager Product Development Media and Process, Sartorius

Intensified processes provide an attractive opportunity to address these challenges. In this webinar, we introduce a service toolbox enabling streamlined development of CHO cell lines for different molecule types. It flexibly links modular routes from DNA to Research Cell Bank, MCB manufacturing, and early upstream development and includes options for intensified processes. 
Learn More

Tuesday, December 8th, 2020

Pharmaceutical companies have spent the past eight months strategizing and waiting for clinical trials to resume. Now that product development has resumed, aseptic filling is a crucial step — and possible bottleneck — to regaining lost time. Whether companies are looking for a contract manufacturing organization (CMO) or bringing filling operations in-house, this webinar will help to drive faster decision making around the establishment of a manufacturing strategy.
Learn More

Friday, December 4th, 2020

Pietro Forgione, VP Biopharma Strategy, IDBS

IDBS are announcing the world’s first Biopharma Lifecycle Management (BPLM) system – a cloud-based platform that smooths the bumps of biopharmaceutical development – easing the curation of the data you need to accelerate time to market. All done by tackling the biggest challenges in process design, optimisation, scale-up and technology transfer.
Learn More

Wednesday, December 2nd, 2020

Sebastian Kundel, Senior Product Manager, Burkert Fluid Control Systems

In this webinar we will discuss how with decentralized solutions for process automation and coordinated, digital communication, e.g. via IO-Link, a transparent and flexible plant design with fast localization and elimination of faults as well as simple installation and commissioning can be realized.
Learn More

Wednesday, December 2nd, 2020

Marcus Bayer, Market Segment Manager, Hamilton Bonaduz AG

The webinar will discuss the immense progress that has been achieved in SUT recently. We are excited to show the capabilities of the newest in-line, single-use pH and dissolved oxygen sensors that improve the measurement and control of bioprocesses while reducing the need for excessive operator oversight or the burden of process intervention at the same time. Our presenters will share data of an integrated solution that offers the tangible benefits of in-situ, pre-irradiated, pre-calibrated, low drift, and long-term dry storage shelf life pH sensors.
Learn More

Wednesday, December 2nd, 2020

Ines Hartmann, Application Specialist Cell Handling, Eppendorf AG

In this webinar, we will depict the typical applications of shakers and bioreactors in an upscaling bioprocess. We will highlight applicational differences and factors that influence cultivation and system transition. Furthermore, we will introduce to you the basic components of a bioreactor and the various process parameters that can be controlled. Finally, we will go through different process strategies to further optimize a process and increase production.
Learn More

Thursday, December 3rd, 2020

Xindao Mao, Product Manager Chromatography Systems

Process intensification is one possibility to meet these goals. In the past, the focus of process intensification was mainly on the upstream side, which pushed the bottlenecks into the downstream area. An important step in DSP is mAb capture. Here the mAb is very specifically captured by a protein A ligand, resulting in >95% of purity. For several decades the default technology has been the use of packed bed column chromatography and diffusion-limited affinity resins. This is a significant pain point in the downstream process, as the flow rate limitations and subsequent underutilization of these resins present considerable investments and process risks for drug manufacturers. Rapid Cycling Chromatography (RCC) is one way to overcome the limitations of processes based on protein A resins.

In this exciting webinar, we will present how Sartorius addresses the needs for downstream process intensification with a newly developed Protein A membrane and an optimized RCC skid.
Learn More

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.
Learn More

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.
Learn More

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. 
Learn More

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. 
Learn More

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.
Learn More

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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