Event Alert

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.

Learn More

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.

Learn More

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

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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

Learn More

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 

Learn More

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.

Learn More

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.

Learn More

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

Learn More

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.

Learn More

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.

Learn More

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

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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. 

Learn More

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»

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

Wednesday, May 20th, 2020

Process developers of COVID-19 vaccines need to develop, scale up and build sustainable mass production within the fastest timelines ever in a pandemic situation, and yet must ensure the safety, purity, quality and potency of their vaccines.

We support these challenges with an integrated platform approach that achieves fast development, banking and characterization of your cell line,  rapid characterization and lot release testing of your vaccine, expedited delivery of your ready to use media and proven end-to-end single use manufacturing.

Learn More

Tuesday, May 19th - Thursday, May 21st, 2020

Join us for this live 3-day symposium that brings together scientists from around the globe to discuss their COVID-19 research findings, ideas and technical expertise. Each day leading scientists will present their work, followed by an ask-the-expert panel discussion where the audience can pose their questions to the speakers.

Each day will highlight a new topic with new speakers sharing their expertise on the following: 

- May 19: Understanding the Immune Response
- May 20: Viral Particle Detection & Characterization
- May 21: Vaccine & Therapy Development

Register today for the whole event or select sessions. SEATS ARE LIMITED for this high demand special event.

Learn More

Wednesday, May 20th, 2020

Major progress has been made in the area of gene therapy and due to improved safety and efficacy, the Adeno-Associated Virus (AAV) has emerged as an important vector for the development of gene therapies. With a growing pipeline of clinical trials, it is evident that scalable viral vector manufacturing technologies are needed by this rapidly growing industry. Next to scalability, product safety and purity needs to be demonstrated before regulatory approval is attained.

In this presentation we will discuss the benefits of implementing affinity chromatography in the downstream purification of viral vectors. The utilization of POROS™ CaptureSelect™ AAV affinity resins results in a significant improvement to the downstream process of AAV. By reducing the number of purification steps, maximizing productivity, offering scalability and process consistency, these resins can be used for clinical and commercial manufacturing.

Learn More

Tuesday, May 19th, 2020

Human mesenchymal stem cell (hMSC)-based therapies are of increasing interest in the field of regenerative medicine. In particular for allogeneic therapies, production of large amounts of hMSC is required. However, traditional planar cultivation systems are labor intensive and limited regarding scale-up potential. Stirred-tank bioreactors, on the other hand, can provide the means for controllable, scalable and cost-efficient MSC manufacturing in combination with microcarriers. The identification of suitable microcarriers and culture medium is a critical step for establishing hMSC expansion in stirred-tank bioreactors and further process development.

This webinar will showcase a state of art approach for rapid and systematic screening of various microcarriers and media for hMSC expansion in the Ambr® 15 Cell Culture system using the MODDE® software for the design and statistical analysis of the experiments. Using a DOE approach, we systematically selected the best microcarrier and culture media combinations for the expansion of MSC in stirred-tank bioreactors.

Learn More

Monday, May 18th, 2020

One major challenge of industrial productions is to reduce batch-to-batch variability and its derived additional costs. In the biopharmaceutical industry, government initiatives such as the PAT, push the implementation of real-time bio-process monitoring and control by using in-line/on-line process sensors. These tools enable efficient control of process variability, as long as they deliver reliable and accurate measurements. This challenge is best addressed by so-called "intelligent" sensors. This contribution provides a sensor specialist's view on: "What is an intelligent sensor?" At the same time we will introduce the newer generation of Intelligent Sensors for monitoring Dissolved Oxygen, Cell Density and more.

Learn More

Wednesday, May 13th, 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:

Maria Weinberger:
"The Effect of Pressure Pulsations on Filter Fouling in TFF"

Tero Jansen: 
"Levitronix Single-Use Pump Systems in Pilot Scale TFF Applications"

Filipa Almeida:
"Advantages to Adenovirus Productivity Using a Low Shear Stress Centrifugal Pump during Biorector Perfusion"

Learn More

Wednesday, May 13th, 2020

In this webinar Svea Cheeseman, Product Manager PAT, and Dan Kopec, Product Specialist PAT North America, will showcase how our new BioPAT® Spectro is unlocking the full potential of Raman spectroscopy in high-throughput process development and single-use biomanufacturing.

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 50-2000L

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

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

  • Fully integrated and qualified BioPAT® Spectro single-use port in Flexsafe STR® bags

Learn More

Monday, May 11th, 2020

The scope of process analytical technologies (PAT) is to make production processes reliable through reliable real-time process monitoring and control. When this applies to bioprocesses such as the ones used to produce medicines as e.g. monoclonal antibodies (mAb) or viral vaccines, "reliable" means that the process sensors have to be compliant with the Good Manufacturing Practices (GMP) guidelines. In those regulated companies, computerized systems, such as pH, dissolved oxygen or viable cell density sensors, have to be developed, manufactured and implemented according to guidances like the Good Automated Manufacturing Practices (GAMP).

In this 30-minute live webinar you will learn about:

  • The Regulations and guidances applying to process analytical solutions

  • GAMP 5 and computerized systems: what are we talking about?

  • How GMP users can leverage on suppliers all along the DQ-IQ-OQ-PQ process sensor's lifecycle
  • Examples of product and services ready for Part 11/ Annex 11 compliance  

Learn More

Thursday, May 14th, 2020

By choosing a media supplier that is prepared to partner with manufacturers through the raw materials qualification process and regional regulatory approvals, manufacturers can better address the challenges and opportunities on the road to bringing cell therapies to market.

What will you learn?

Regulatory requirements of different regions and how FUJFILM Irvine Scientific helps the customer understand:   

  • How long the regulatory approval process takes in different regions

  • Unique raw material qualification processes

  • The importance of safety and timelines for choosing a media supplier for clinical trials

  • How the right media supplier helps with media costs

Learn More

Wednesday, May 13th, 2020

The webinar will outline the use of Sartobind membrane chromatography for the purification of virus based biologics also linking to the current COVID-19 pandemic outbreak. The presentation will cover the use of virus based biologics in different biotherapeutic approaches and clearly illustrate the properties and advantages of the Sartobind portfolio in this context.

Speakers:

Ricarda Busse
Product Manager Membrane Chromatography

Consumables Carsten Voss
Product Manager Chromatography Consumables

Learn More

On Demand

In this recorded webinar Thomas Wurm, Managing Director at Single Use Support, explains the importance of scale-up technologies to the biopharma industry. The informative presentation includes interesting facts, demonstrations and studies with a tie-in to the current situation with COVID-19: as soon as one vaccine against the pandemic will be approved from FDA and EMA, how can manufacturer scale up from clinical phases to commercialization by maintaining the same product quality?

Learn More

Monday, May 4th, 2020

This presentation first describes how vaccine developers can accelerate their timelines and develop highly efficient vaccine processes by using high throughput fully automatic multi-parallel bioreactor testing tools such as ambr, DoE software and single use solutions able to operate with mammalian cells, insect cell and avian cells.

Upstream process intensification methods, scale up tools and real case data will be presented for both suspension and adherent cell culture in fed batch, concentrated fed batch or perfusion mode. In particular, we will show how intensifying the working cell bank and the seed train bioreactor with perfusion helps saving half of the consumable costs and reduces the main bioreactor cell expansion time by up to 40%.  Moreover, being able to achieve higher titers will be extremely important to keep scale up at a manageable level, which is critical during a pandemic situation.

The author will conclude by show how coupling the production bioreactor with ATF, PAT tools and online multivariate process monitoring software can provide 10 to 50 times higher cell density and full automation and predictive control of the cell culture process performance.

Learn More

Tuesday, May 5th, 2020

This 15-minute webinar presents the unique (patented) control for processes using MCSGP found on YMC Contichrom systems.  Performing Multicolumn Countercurrent Solvent Gradient Purification (MCSGP), operation with MControl significantly reduces effects on product quality caused by temperature, solvent quality, conductivity, pH and/or column variability (bed height, aging, packing quality...).

MControl compensates for peak shifts by adjusting the fractionation start:  Same product fraction position, Same product quality, Increased robustness of continuous process operation.

Learn More

Tuesday, May 12th, 2020

Dielectric spectroscopy (DS), also known as capacitance measurement, has been used as a PAT tool for vaccine and viral vector production processes (adenovirus, lentivirus reovirus, influenza, baculovirus) with mammalian and insect cells. It has been viewed as an important process control tool for continuous virus production processes. 

Numerous groups have explored this technology to monitor live cell density, identify critical events and control the process. The benefits of using capacitance technology in these applications are multifold. Considering capacitance measurement correlates with the live cell density (or more accurately, viable biovolume) profile of the culture, it provides a complete, real time and detailed picture of all of the critical events. This leads to better process monitoring, automation and control and in turn, improved productivity.

This concise webinar will comprise of a 20 minute presentation followed by a 10 minute Live Q&A.  

Learn More

On-Demand

Viewers of this webinar will learn how to make decisions faster using easy, compliant, repeatable, more accurate at-line protein concentration measurements. The SoloVPE™ Device using novel Slope Spectroscopy® technology takes the guess work out of critical bioprocessing analytics steps.

Features Include

  • No sample preparation or dilution needed
  • Reduces deviations in manufacturing floor analysis
  • Aligns multi-site analytical methods

Learn More

Wednesday, April 29th, 2020

In this virtual launch event, we will reveal a browser-based platform for data acquisition, aggregation and analysis uniquely developed by biopharma peers to effectively manage the velocity and volume of complex, disparate electronic and batch record data sources across the process and product lifecycle in near real-time.

Reserve your virtual seat today and learn how our new suite of software, specifically conceived by bioprocess engineers for bioprocess engineers, will provide you with enhanced process control, data and process analytics, faster decision-making and a deep and insightful understanding of your bioprocess.

Learn More

Monday May 4th, 2020

We are all witness to the impact of the COVID-19 pandemic across the world, as it is bringing economies and life in general to a halt. In response to this pandemic, there are more than 90 vaccine candidates today that are in pre-clinical phase, with a few companies entering clinical trial phase I. We know that speed is of essence and that scale-up to large-scale production needs to be achieved by strategically balancing risks and speed.

This presentation will first describes how vaccine developers can accelerate their timelines and develop highly efficient vaccine processes by using high throughput fully automatic multi-parallel bioreactor testing tools such as ambr®️, DoE software and single use solutions able to operate with mammalian cells, insect cell and avian cells. 

It will conclude by showing how coupling the production bioreactor with ATF, PAT tools and online multivariate process monitoring software can provide 10 to 50 times higher cell density and a the full automation and predictive control of the cell culture process performance.

Learn More

Wednesday, May 13th, 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 component suppliers work together. The Levitronix Bioprocessing Webinar brings industry professionals together to make a change.

Speakers:

Maria Weinberger, Technical University of Munich, Research Associate
"The Effect of Pressure Pulsations on Filter Fouling in TFF"

Filipa Almeida, Psioxus, Process  Development Scientist
"Advantages to Adenovirus Productivity Using a Low   Shear Stress Centrifugal Pump during Biorector Perfusion"

Tero Jansen, Biovian, Process Engineer
"Levitronix Single-Use Pump Systems in Pilot Scale TFF Applications"

Learn More

Wednesday, April 29th, 2020

In this virtual launch event, we will reveal:

A browser-based platform for data acquisition, aggregation and analysis uniquely developed by biopharma peers to effectively manage the velocity and volume of complex, disparate electronic and batch record data sources across the process and product lifecycle in near real-time.

Reserve your virtual seat today and learn how our new suite of software, specifically conceived by bioprocess engineers for bioprocess engineers, will provide you with enhanced process control, data and process analytics, faster decision-making and a deep and insightful understanding of your bioprocess.

Learn More

On-Demand

Dielectric spectroscopy has been successfully used in the bioprocess industry to measure cell density in bioreactors for close to three decades. With FDA's PAT initiative, capacitance based cell density measurements have become even more relevant and valuable.The ability to measure viable cells exclusively, in-situ and in real time makes this technology stand apart from others. Over the years, it has been used for a variety of applications that include not only monitoring the cells, but also automatically controlling a critical aspect of the process.

In this webinar you will learn:

  • How dielectric spectroscopy is used to measure viable biomass in real-time.
  • Understand how the technology has evolved and about current practices in manufacturing.
  • Learn from case studies how the technology has been used to improve manufacturing performance.

Learn More

Tuesday, April 21st, 2020

Digitalization means a more productive and adaptive plant through the application of analytics to leverage connectivity and data - maximizing efficiency from people, processes, equipment and core systems. How? By facilitating data driven decisions. Raman spectroscopy enables real-time compositional analysis for in-process control making it a rich data source to drive process efficiency and optimization.

Kaiser's latest Raman analyzers with embedded controls embrace digitalization and take a proactive approach to transition spectroscopy platforms to Industry 4.0 standards. Raman Rxn™ embedded analyzers improve connectivity, reliability and scalability in the age of IIoT. This has been demonstrated by the biopharmaceutical industry utilizing Raman-based analytics to ensure product and process consistency, save time and resources, and improve bioprocess efficiency. In this webinar, we will present advances in IIoT-ready Raman technology and application examples from the biopharmaceutical industry.

Learn More

Tuesday, April 21st, 2020

Adherent and suspension bioreactors for viral vector manufacturing are evolving. However, for each choice, a robust manufacturing process is critical to ensure it is scalable for these novel therapies to reach the patients.

One of the first steps in designing a process is whether to use adherent or suspension cell cultures. Each modality has its advantages and disadvantages. In this webinar, the panelists will outline key considerations in choosing the right technology and some of the pitfalls that must be overcome to ensure success at large scale.

Participants will learn:

  • What factors to consider when choosing your cell culture
  • The advantages and pitfalls with each type of culture
  • The bioreactor choices available to support each type of culture

Learn More

96-Well Plate: A Streamlined Format for Cell Culture Monitoring with Cedex Bio HT Analyzer

On Demand

A myriad of factors are decisive in the development of successful cell culture upstream processes. Efficiency in testing and evaluating these parameters is a key consideration for setups and workflows that is often solved through robotics in different fields. The ultimate goal for modern cell culture upstream processes is a fully automated system for the repeated, controlled and preferably hands-off monitoring of multiple concurrent processes, from sample collection through data analysis and resulting feedback loops.

At Roche Pharma Cell Culture Research, highly parallelized bioprocessing using microscale bioreactors (bioreactor farms) enabled such high-throughput efficiency but called for an innovative solution to capture and analyze data from multiple, concurrently running fermenters.

Join this webinar to 

  • See the Roche set-up for high throughput sample testing in action
  • Learn about the efficient workflow with a pipetting robot, the recently integrated 96 well plate and smart data processing

Learn More

Tuesday, May 12th, 2020

In consideration of public health measures being taken by us and our customers, Asahi Kasei Bioprocess America, Inc. is offering the Planova Operators Course via Skype. 

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.

Learn More

Tuesday, April 21st

Adherent and suspension bioreactors for viral vector manufacturing are evolving. However, for each choice, a robust manufacturing process is critical to ensure it is scalable for these novel therapies to reach the patients.

One of the first steps in designing a process is whether to use adherent or suspension cell cultures. Each modality has its advantages and disadvantages. In this webinar, the panelists will outline key considerations in choosing the right technology and some of the pitfalls that must be overcome to ensure success at large scale.

Participants will learn:

  • What factors to consider when choosing your cell culture
  • The advantages and pitfalls with each type of culture
  • The bioreactor choices available to support each type of culture

Learn More

On Demand

A myriad of factors are decisive in the development of successful cell culture upstream processes. Efficiency in testing and evaluating these parameters is a key consideration for setups and workflows that is often solved through robotics in different fields. The ultimate goal for modern cell culture upstream processes is a fully automated system for the repeated, controlled and preferably hands-off monitoring of multiple concurrent processes, from sample collection through data analysis and resulting feedback loops. 

At Roche Pharma Cell Culture Research, highly parallelized bioprocessing using microscale bioreactors (bioreactor farms) enabled such high-throughput efficiency but called for an innovative solution to capture and analyze data from multiple, concurrently running fermenters.

Join this webinar to:

  • See the Roche set-up for high throughput sample testing in action

  • Learn about the efficient workflow with a pipetting robot, the recently integrated 96 well plate and smart data processing

Learn More

Wednesday, April 29th, 2020

As industry 4.0 principles are applied to and adopted in the biotech environment - also known as Bioprocessing 4.0 - the convergence of various disciplines such as advanced bioprocessing technologies with software, automation and analytics is crucial.  Using a convergent toolbox of digitally-connected, intensified and continuous technologies will allow for reduced costs with increased quality, flexibility, and speed.

Reserve your virtual seat today and learn how our new suite of software, specifically conceived by bioprocess engineers for bioprocess engineers, will provide you with enhanced process control, data and process analytics, faster decision-making and a deep and insightful understanding of your bioprocess.

Learn More

Tuesday, May 5th, 2020

Filter integrity test values are part of the batch protocol and are used to justify the drug release. Long term reliable data is therefore crucial to avoid quality deviations and potential 483 warning letters. Devastating malware incidents and the continuing threat of computer viruses have created an urgent need for data protection and security. Join this webinar to learn more about how the Sartocheck 5 Plus can help you reach the ultimate level of Data Integrity.

Key Objectives:

  • Get full understanding of the importance of data integrity and data security related to filter integrity test results
  • Get an insight on how the Sartocheck®5 Plus Filter Tester has been designed for inherent resistance against data virus and malware
  • See how the Sartocheck®5 Plus Filter Tester fulfills the ALCOA+ principles

Learn More

On Demand

For cultivation of mammalian cells in biopharmaceutical research and manufacturing, single-use technology possesses several advantages to autoclavable material. Bioreactor scalability is critical to streamlining the adaptation of culture volumes during process development and manufacturing.

In this webinar, we discuss several scaling approaches, such as constant tip speed, kLa, and power number-based scale-up. Data will be underlined with two case studies.

Learn More

Wednesday, April 1st, 2020

This webinar will examine mixed-mode chromatography for biomolecule purification. The ligand design impacts the strength and specificity of the interactions. Multiple interactions between stationary and mobile phases lead to unique selectivities and can facilitate separation of closely related proteins and contaminants.
Discussion Topics:

  • Higher resolution compared to unimodal interactions
  • Improved yield and activity
  • Large design space for protein interaction
  • Minimal feed manipulation prior to binding
  • Mild operating conditions preserve activity

Learn More

On Demand

For cultivation of mammalian cells in biopharmaceutical research and manufacturing, single-use technology possesses several advantages to autoclavable material. Bioreactor scalability is critical to streamlining the adaptation of culture volumes during process development and manufacturing.

In this webinar, we discuss several scaling approaches, such as constant tip speed, kLa, and power number-based scale-up. Data will be underlined with two case studies.

Learn More

July 20th - July 30th, 2020

Presented by G-CON Manufacturing and Vanrx Pharmasystems

What if isolator filling lines were ordered fully integrated, fully qualified, installed in their fully integrated and qualified surrounding classified environment, all with guaranteed functionality? Well, this need has become a reality. Come see the first and only turnkey facility for aseptic filling of advanced therapies, Microcell POD.

Attendees will have the opportunity to:

- Discuss the paradigm shift in biopharma filling solutions
- Learn the features and benefits of Microcell POD
- Speak with G-CON and Vanrx sales and engineering  experts
- Tour a live example of the Microcell POD

Learn More

Wednesday, June 3rd, 2020

Presented by Dan Hill, Manufacturing Scientist at 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.

Learn More

Wednesday, November 11th, 2020

The joint UMass Lowell & YMC ChromaCon course hands-on training related to multicolumn chromatography operation and theory with support from MilliporeSigma will include training on continuous downstream processing. 

The course will include discussions on design of continuous capture and polish processes, validation, process economy and operational excellence. Training will take place at UMass and will include practical lab work including experimental design and execution of continuous capture chromatography. 

Learn More

Tuesday, March 24th, 2020

KinetiSol® is a high-energy, fusion-based solubility enhancement technology that is used to generate pharmaceutical amorphous solid dispersions (ASDs) without the assistance of solvent and often below the melting point of the active pharmaceutical ingredient (API). 

Kaiser Raman spectroscopy is being used as an at-line process analytical technology (PAT) for polymorphic content analysis of KinetiSol®-generated ASDs. Crystalline content is analyzed using a Kaiser Raman 785nm analyzer with a PhAT probe immediately upon ejection of the shots from KinetiSol® compounders, eliminating the time constraints of off-line powder X-ray diffraction (XRD) analysis. Spectral features reflecting the polymorphic content of the shots have been analyzed using multivariate techniques such as partial least squares regression (PLSR) analysis and support vector machines (SVM) classification. 

Learn More

Thursday, March 19th, 2020

Complex fluids such as liposomes are increasingly being used as a vehicle for drug delivery, but due to their nature, efficient and large-scale manufacturing can be challenging. One such challenge is sterile filtration, both from a throughput and bacterial retention standpoint. 

Producing liposomes with precisely controlled particle size and distribution ensures an efficient downstream sterile filtration process. To overcome sterile filtration challenges appropriate decisions must be made during the selection, evaluation, and validation of filters intended for the sterilization of liposome-based drugs.

Learn More

Monday, March 23rd, 2020

Get it right from the start with Design of Experiments (DOE)! As anyone in product development knows, getting things right from the start is a challenge. Especially with many parameters to take into account. For industries like Pharma and Biopharma where outcomes are critical and the competition is fierce, you need tools that you can be sure will get you to the market on time; design of experiments (DOE) is indispensable in this context.

Join this webinar and discover what DOE is and what makes it so useful. Learn about the fundamental uses of DOE (screening, optimization and robustness testing) and how these applications can generate value from your data. 

Learn More

Thursday, March 19th 2020

Complex fluids such as liposomes are increasingly being used as a vehicle for drug delivery, but due to their nature, efficient and large-scale manufacturing can be challenging. One such challenge is sterile filtration, both from a throughput and bacterial retention standpoint.

Producing liposomes with precisely controlled particle size and distribution ensures an efficient downstream sterile filtration process. To overcome sterile filtration challenges appropriate decisions must be made during the selection, evaluation, and validation of filters intended for the sterilization of liposome-based drugs.

Learn More

Thursday, May 28th, 2020

UMass Lowell

Hosted by UMass Lowell, YMC / ChromaCon - The joint UMass Lowell & YMC ChromaCon course hands-on training related to multi-column chromatography operation and theory will include instruction on continuous chromatographic processing. The course will focus the design of continuous capture and polishing processes, validation, process economy and operational excellence with special emphasis on techniques to purify peptides, oligos, ADC's and isoforms. Training will take place at UMass and will include practical lab work including experimental design and execution of continuous capture chromatography.

Learn More

Tuesday, March 24th, 2020

10:00 AM EST

KinetiSol® is a high-energy, fusion-based solubility enhancement technology that is used to generate pharmaceutical amorphous solid dispersions (ASDs) without the assistance of solvent and often below the melting point of the active pharmaceutical ingredient (API). Kaiser Raman spectroscopy is being used as an at-line process analytical technology (PAT) for polymorphic content analysis of KinetiSol®-generated ASDs. Crystalline content is analyzed using a Kaiser Raman 785nm analyzer with a PhAT probe immediately upon ejection of the shots from KinetiSol® compounders, eliminating the time constraints of off-line powder X-ray diffraction (XRD) analysis.

Learn More

April 19th - 24th, 2020 

Albufeira, Portugal

The first ECI Conference on Microbial Engineering in March 2018 in Santa Fe, New Mexico brought together leaders in Synthetic Biology, Metabolic Engineering and Fermentation Technology both from industry and the academic community. Examples of applications included natural products, therapeutic proteins, vaccines and biosynthesis of a great variety of organic chemicals.

Learn More

Friday, April 3rd - Tuesday, April 21st, 2020

What if isolator filling lines were ordered fully integrated, fully qualified, installed in their fully integrated and qualified surrounding classified environment, all with guaranteed functionality? Well, this need has become a reality. Come see the first and only turnkey facility for aseptic filling of advanced therapies, Microcell POD.

Attendees will have the opportunity to:

  • Discuss the paradigm shift in biopharma filling solutions
  • Learn the features and benefits of Microcell POD
  • Speak with G-CON and Vanrx sales and engineering experts
  • Tour a live example of the Microcell POD

Learn More

Thursday, June 18th, 2020

Hotel Royal Sonesta, Cambridge, MA

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, systems, and components suppliers work together. The Levitronix Bioprocessing Conference brings industry professionals together to make a change.

Learn More

Presented by ECI

April 19th - 24th, Albufeira Portugal

The first ECI Conference on Microbial Engineering in March 2018 in Santa Fe, New Mexico brought together leaders in Synthetic Biology, Metabolic Engineering and Fermentation Technology both from industry and the academic community. Examples of applications included natural products, therapeutic proteins, vaccines and biosynthesis of a great variety of organic chemicals.  Based on the success of this meeting we plan to hold a second ECI Conference "Microbial Engineering II" in Albufeira, Portugal.  We are confident that this will capture the exciting progress being made on many fronts and highlight practical applications.

Learn More

Live Webinar

Presented by Dr. Derek C. Lenz, Beckman Coulter

Wednesday, March 11th, 2020

The tale of Goldilocks is as timeless, informative and relevant to biopharma, as it is generally for society.

Specifically, as it pertains to culturing cells, lessons conveyed by this fairy tale are both obvious and subtle; media composition, ambient conditions and other key parameters must be maintained within specific ranges for production of robust cells and sub-cellular products.

However, optimising those very conditions serve to create a negative feedback loop, as the cells perturb the balance of healthy culture conditions through normal in vitro metabolic processes. In many cases, the negative variance can quickly become irreversible and fatal to the cell culture. Thus, accurate, repeatable and verifiable analytical instruments and processes are required to maintain an appropriate Biological Goldilocks Zone.

Learn More

Live Webinar

Thursday, February 13th, 2020

Viral vectors for gene therapy have shown tremendous clinical promise which has spurred a huge increase in demand for manufacturing space, resulting in a capacity crisis. This is currently delaying the commercialization of these gene therapies for which time to market is critical.

Integrated solutions for viral vectors designed within modular cleanroom facilities streamline manufacturing and reduce time to market. Pall Biotech and G-CON manufacturing have partnered to design and deploy an integrated manufacturing solution to address the current capacity constraints for viral vector manufacturing.
Participants will learn: 

  • The manufacturing challenges facing the viral vector industry
  • The advantages of an integrated manufacturing solution
  • How to develop and deploy a new manufacturing facility in 10 months within a modular cleanroom 

Learn More

Online Product Launch

Wednesday, February 12th, 2020

Join us when we unveil the latest family member of the Eppendorf Bioprocess product family: Our next-generation bioprocess controller. Curious? Join one of the two sessions

9 AM CET / 4 PM CST
5 PM CET / 8 AM PST / 11 AM EST

The online event will take approximately 60 minutes. During the event, we will introduce our brand-new bioprocess controller and you will have the opportunity to see and learn more about it in the virtual showroom. You will be able to log in 15 minutes before the official start and are welcome to explore the virtual conference area, before joining us in the auditorium.

Learn More

On-Demand Webinar

Accumulation of CO2 in fermentation and cell cultures can become a significant problem affecting productivity and product quality of recombinant proteins and monoclonal antibodies (mAbs). During this webinar, the following topics will be approached with a technical perspective:

  • Measuring CO2 inline and monitor its accumulation
  • Elevated CO2 partial pressure (pCO2) can alter protein glycosylation and affects the purity of mAbs
  • pCO2 is affecting media and intracellular osmolality
  • Measuring pCO2 offline versus inline
  • Monitoring and controlling CO2 during a fermentation

A list of scientific references for fermentation and cell culture processes will be also communicated and available after the webinar.

Learn More

Friday, April 3rd - Tuesday, April 21st, 2020

What if isolator filling lines were ordered fully integrated, fully qualified, installed in their fully integrated and qualified surrounding classified environment, all with guaranteed functionality? Well, this need has become a reality. Come see the first and only turnkey facility for aseptic filling of advanced therapies, Microcell POD.

Attendees will have the opportunity to:

  • Discuss the paradigm shift in biopharma filling solutions
  • Learn the features and benefits of Microcell POD
  • Speak with G-CON and Vanrx sales and engineering experts
  • Tour a live example of the Microcell POD

Learn More

Wednesday, February 12th, 2020

Join us when we unveil the latest family member of the Eppendorf Bioprocess product family: Our next-generation bioprocess controller. Curious? Join one of the two sessions


9 AM CET / 4 PM CST
5 PM CET / 8 AM PST / 11 AM EST

The online event will take approximately 60 minutes. During the event, we will introduce our brand-new bioprocess controller and you will have the opportunity to see and learn more about it in the virtual showroom. You will be able to log in 15 minutes before the official start and are welcome to explore the virtual conference area, before joining us in the auditorium. 

We're looking forward to meeting you at our online conference!

Learn More

Wednesday, January 29th, 2020

This webinar will discuss the system requirements for immunoglobulin and albumin within existing commercial processes regarding automation, process & product safety, piping diameters and system volume. Secondly the requirements for the filter cassettes is under focus and several aspects will be covered such as membrane choice, screen selection and the determination of the required membrane area. 

Then an overview of the critical process parameters for immunoglobulin and albumin such as recirculation rate, inlet/outlet pressure, flux rates and other relevant parameters will be given. For each process parameter the typical operating ranges will be given which are considered to give a high-quality process.

In the last part of the webinar a few case studies are shown where the performance of PESU based membranes are compared against cellulose based membranes. The productivity of both membranes will be compared for immunoglobulin and albumin based on user data.

Learn More

Presented by Ben Jeyaretnam, E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager at SGS Group

On Demand

The biopharma industry has been increasingly using single use systems (SUS) for bioprocessing and storage of intermediate and final bulk material in addition to primary packaging. Before a SUS could be used in the manufacturing process, it needs to be qualified for use by a pre-determined process. This presentation will discuss a variety of challenges, both internal and external to the industry that the end use faces during the qualification process. Complexity of SUS, varying quality of vendor data, component change management, changing regulatory expectations, analytical data generation, logistical challenges during E&L study execution, analytical challenges, and the potential impact of unexpected E&L study results will be presented.

Learn More

Presented by Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D'Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific

On Demand

Extractable and Leachable (E&L) studies on materials used in the manufacturing process and container closer systems of drug products and drug substances are commonly used to assess the risk for patient exposure. Most often LC-MS or GC-MS is used to detect, identify and then quantify extractables and leachables. In general, an analytical evaluation threshold or reporting threshold is set based on a calculated patient exposure. Substances above the set threshold required further investigation if patient exposure exceeds this. In this webinar we will discuss an approach for different levels of identification and how to increase the level of confidence of identified extractables and leachables.

Learn More

Wednesday, January 29th, 2020

This webinar will discuss the system requirements for immunoglobulin and albumin within existing commercial processes regarding automation, process & product safety, piping diameters and system volume. Secondly the requirements for the filter cassettes is under focus and several aspects will be covered such as membrane choice, screen selection and the determination of the required membrane area. In the last part of the webinar a few case studies are shown where the performance of PESU based membranes are compared against cellulose based membranes. The productivity of both membranes will be compared for immunoglobulin and albumin based on user data.

Learn More

Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen

On-Demand

Biogen is adopting modeling maturity models similar to the ones used by high tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial particularly when implementing data driven models that rely on process experience. A well-planned modeling continuum should allow the pharmaceutical industry to realize the benefits from modeling activities early on, while evolving into more mature prescriptive controllers.

Learn More

Wednesday, January 29th, 2020

This webinar will discuss the system requirements for immunoglobulin and albumin within existing commercial processes regarding automation, process & product safety, piping diameters and system volume. Secondly the requirements for the filter cassettes is under focus and several aspects will be covered such as membrane choice, screen selection and the determination of the required membrane area.

In the last part of the webinar a few case studies are shown where the performance of PESU based membranes are compared against cellulose based membranes. The productivity of both membranes will be compared for immunoglobulin and albumin based on user data.

Learn More

On Demand
Presented by Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology, Technical Operations at Janssen Pharmaceuticals


The presentation shares the journey that Janssen is taking as it progresses its strategy on Advanced Process Control (APC). Within Janssen we aspire to improve our Manufacturing Technology Organization's performance on key metrics such as cost of goods, on time and in full product delivery, production cycle time, and right first-time. Improving these metrics require a comprehensive technology strategy that addresses all the metrics together. Janssen' s strategy has three pillars. 1: process intensification, 2: modular and flexible designs, and 3: process digitalization and advanced process control. Each pillar contributes differently to the key metrics but in aggregate make it possible to reach our goals.
Learn More

On Demand

Presented by Akunna Iheanacho, PhD, Director of Research and Development at Texcell and Xuemei He, PhD, R&D Manager, Chromatograpy Media Chemistry at Bio-Rad Laboratories

Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development. In this case study, we utilize a DOE approach to investigate the effect of buffer pH and conductivity on the removal of various product- and process-related impurities, including the minute virus of mice (MVM), by a mixed-mode chromatography resin, Nuvia aPrime 4A. 
Results from this study have offered insights on the interactions between the resin and MVM particles and the design space for the removal of this virus. Practical considerations for developing a mixed-mode chromatography process with effective overall impurity clearance will also be discussed in this webinar. 
Learn More

Thursday, December 19th, 2019

Presented by: Dr. Ir. Robert Mans - Delft University of Technology (TU Delft)

Evolutionary engineering of microbes provides a powerful tool for untargeted optimization of (engineered) cell factories and identification of genetic targets for further research. Directed evolution is an intrinsically time-intensive effort and automated methods can significantly reduce manual labor. Those automated methods can be used to evolve yeast cultures for more than 1,000 generations and are designed to require minimal manual intervention.

Register and learn more about:

  • Introduction into why and when to use evolutionary engineering for microbial strain optimization
  • Experimental design considerations for various automated evolutionary engineering cultivation methods
  • Overview of recently developed generic workflows and control software for batch, chemostat and accelerostat based evolution in automated bioreactors

Learn More

On Demand

Post-approval changes (PAC), especially for vaccines and therapeutic proteins, have been hindered by different regional regulatory requirements and a conservative industry mindset. Manufacturing science and technology (MSAT) experts within our company have leveraged their knowledge to support an industry shift towards innovation and continuous improvement. Collaborations with drug manufacturers over the years have built our knowledge to understand the unit operations of drug manufacturing correlated with risk. In addition, many small-scale models at our company, aligned with current regulations, have been utilized to support these risk assessments.

In this webinar, you will learn:

  • An understanding of the real regulatory constraints and intents
  • Guidance and case studies that will help clarify critical factors for decision making
  • Detailing conditions to be fulfilled and supporting documentation needed for specific cases

Learn More

Thursday, December 5th, 2019

Product life cycle normally consists of 3 phases: Process Design, Process Performance Qualification and the last and the lengthiest Continued Process Verification (CPV) which goes throughout the lifespan of the product. CPV has become a part of the observations in recent warning letters of regulators either due to lack of complete understanding of the concept, or lack of right tools to perform CPV in an efficient way.

In this webinar, you will learn:

  • Strategy and all associated components required to establish a compliant and efficient continued process verification (CPV) program within your organization.

Learn More

Wednesday, December 4th, 2019

MolMed is a biotechnology company focused on research, development and manufacturing of innovative therapies to treat cancer and rare genetic diseases.  MolMed has developed a robust and scalable process for the industrial scale production of both LV and RV vectors for use in gene-modified cell therapy using the iCELLis® bioreactor platforms.  In this webinar, Molmed will present the development and optimization of their LV and RV vector production processes.

Don't miss this detailed case study from Giuliana Vallanti, PhD at MolMed and Clive Glover, PhD at Pall Biotech followed by a live Q&A

Learn More

Tuesday, December 3rd, 2019

Viral vector-based vaccines are a promising field in vaccinology and are taking more importance in the overall vaccine pipeline. They elicit a strong immune response in patients, avoid the use of highly pathogenic viruses - such as Ebola - and most important are "platform-able". However, viruses are complex entities to produce and purify. The downstream process should be able to remove process and product related contaminants while maintaining the infectious titer, which is a challenge.

In this webinar, Amélie Boulais will describe how the first high throughput ambr® multi parallel testing tool applied to downstream and the Design of Experiment software can simplify and accelerate viral vector purification process development. A case study on an Adenovirus at a 20L scale will show how membrane chromatography and large-cut off cross-flow cassettes can further simplify and intensify the purification process of common viral vectors used for vaccines.

Key Learning Objectives

  • Understand solutions to intensify viral vector purification
  • Discover tools to speed-up process development
  • Configure single-use process scale equipment for viral vectors purification
  • Learn how data analytics can be used for predictive control

Learn More

On Demand

Post-approval changes (PAC), especially for vaccines and therapeutic proteins, have been hindered by different regional regulatory requirements and a conservative industry mindset. Manufacturing science and technology (MSAT) experts within our company have leveraged their knowledge to support an industry shift towards innovation and continuous improvement. Collaborations with drug manufacturers over the years have built our knowledge to understand the unit operations of drug manufacturing correlated with risk. In addition, many small-scale models at our company, aligned with current regulations, have been utilized to support these risk assessments.

Against common assumptions, many of the manufacturing system and raw material changes that are typically considered major, could be categorized as moderate and minor changes. During this presentation, PAC case studies based on selected collaborations will be presented, highlighting a science and risk-based approach to foster effective manufacturing changes and improvements.

Learn More

Wednesday, November 27th, 2019

Single-use (SU) technology is without question one of the key technologies for the development of the biopharmaceutical industry and the manufacturing of drug products. SU equipment is used especially for scalable application such as the production of vaccines, CAR T cells, monoclonal antibodies (mAb), or the manufacturing of biosimilars. One of the main concerns over the last decades continues to be extractables from SUS which potentially are released into the process solutions as process equipment-related leachables (PERLs). In this context, the assessment of extractables is required for the process qualification.

The webinar focuses on the strategy developed by Sartorius Stedim Biotech (SSB) to provide the most detailed extractables data enabling our customers to implement rapidly and cost-effectively SU equipment into bioprocessing applications. The analytical and component approach is presented. Scaling exercises and the toxicological evaluation is exemplified using data of the current SSB Extractable Guide of a widely-used sterile filter of the Sartopore® family.

Learn More

Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia

Tuesday, November 26th, 2019

The complexity of biotherapeutic products and their manufacturing processes can yield a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. These impurities can be broadly grouped into two categories: The first, product-related impurities, such as precursors, aggregates and degradation products, and the second, process-related impurities, such as host cell DNA, host cell protein, and particulates.  This presentation will provide an overview of different approaches for monitoring impurities, including a discussion of existing USP standards and standards under development to support impurity testing.

Learn More

Wednesday, November 20th, 2019

Data Analytics is one of the key trends within the pharmaceutical industry, both for the production of 'classical' drugs as well as large molecules. Companies are looking for ways to shift from the traditional way of operations to a more smart and optimal approach. The main advantages associated with such processes are more room for modularity, automation, and flexibility due to a smaller footprint, but also a more consistent quality of the drug product. The regulatory bodies see the promise of these processes and actively promote companies to implement this manufacturing strategy. This is illustrated by the recently published draft guidelines from the FDA for the production of small molecule drugs using continuous processes and the active discussion with the (bio)pharmaceutical industry through their Emerging Technology Program.

The amount of data and information generated in continuous and batch processing creates new opportunities to expand the use of multivariate process modeling. This webinar will cover and expand upon the MVDA and DOE offerings of Sartorius as a part of the Umetrics Suite while covering different modes of implementation, advantages and talk about why data analytics is now a cardinal need of the industry.

Learn More

Presented by: Dr. Ir. Robert Mans - Delft University of Technology (TU Delft)

Thursday, December 19th, 2019

Evolutionary engineering of microbes provides a powerful tool for untargeted optimization of (engineered) cell factories and identification of genetic targets for further research. Directed evolution is an intrinsically time-intensive effort and automated methods can significantly reduce manual labor. Those automated methods can be used to evolve yeast cultures for >1,000 generations and are designed to require minimal manual intervention.

Topics:

  • Introduction into why and when to use evolutionary engineering for microbial strain optimization
  • Experimental design considerations for various automated evolutionary engineering cultivation methods
  • Overview of recently developed generic workflows and control software for batch, chemostat and accelerostat based evolution in automated bioreactors

Learn More

Wednesday, November 27th, 2019

Single-use (SU) technology is without question one of the key technologies for the development of the biopharmaceutical industry and the manufacturing of drug products. SU equipment is used especially for scalable application such as the production of vaccines, CAR T cells, monoclonal antibodies (mAb), or the manufacturing of biosimilars. One of the main concerns over the last decades continues to be extractables from SUS which potentially are released into the process solutions as process equipment-related leachables (PERLs). In this context, the assessment of extractables is required for the process qualification.

The webinar focuses on the strategy developed by Sartorius Stedim Biotech (SSB) to provide the most detailed extractables data enabling our customers to implement rapidly and cost-effectively SU equipment into bioprocessing applications. The analytical and component approach is presented. Scaling exercises and the toxicological evaluation is exemplified using data of the current SSB Extractable Guide of a widely-used sterile filter of the Sartopore® family.

Learn More

Tuesday, November 12th, 2019

Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development. In this case study, we utilize a DOE approach to investigate the effect of buffer pH and conductivity on the removal of various product- and process-related impurities, including the minute virus of mice (MVM), by a mixed-mode chromatography resin, Nuvia aPrime 4A. Results from this study have offered insights on the interactions between the resin and MVM particles and the design space for the removal of this virus. Practical considerations for developing a mixed-mode chromatography process with effective overall impurity clearance will also be discussed in this webinar.

Learn More

Tuesday, November 26th, 2019

Until recently, the European pharmaceutical industry could only produce WFI via distillation. That all changed in April 2017 when the European Pharmacopeia revised monograph 0169 to allow WFI production through the cold process of reverse osmosis (RO). While RO-based systems can offer benefits like lower operating costs, they also pose extra challenges.

In this live 45-minute webinar you'll learn:

  • The benefits of producing WFI through RO-based systems
  • The challenges of RO-based systems and how you can overcome these
  • How the costs, risks and sustainability of RO-based systems compare to other WFI production methods
  • Whether Cold WFI is a good fit for your facility

You'll have the chance to ask questions, and after the webinar you'll receive a recording to watch again in your own time.

Learn More