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Pharma and Biopharma Manufacturing Webinars

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Take part in our complimentary, live webinars, where you’ll interact with experts who are breaking ground in the pharmaceutical and biopharmaceautical industries. You’ll learn about the newest tools and technologies while gathering valuable tips and troubleshooting strategies for the applications most relevant to your processes.

Find an upcoming webinar below and register today!

Reducing Risk and Decreasing Timelines for Biopharmaceutical Cell Line Development Through Optimized Reagents and Processes

  • Presenter: Kate Achtien, Senior R&D Scientist
  • Date: Thursday, November 30, 2017
  • Duration: 1 Hour
  • Session: 11:00 AM EST, 8 AM PST, 5 PM CET
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 Abstract:
Join us to learn about challenges faced with traditional expression systems and how a CHO cell line with the glutamine synthetase knock-out via ZFN provides benefits for fast, efficient cell line development with stable and high titer expression.

CHO cells with their unique characteristics, represent the major expression system within the biopharmaceutical industry. However, one of the major challenges in cell line development is to identify those rare, high-producing clones in a huge population of non-expressing or low-expressing cell lines. This leads to laborious and time consuming cell line development processes. This webinar will educate the audience about challenges faced with traditional expression systems and how the CHO cell line with the glutamine synthetase knock-out via Zinc Finger Nucleases provides benefits for fast and efficient cell line development as well as stable and high titer expression. We will explore additional cell line engineering targets that can be modified to engineer a cell line that mitigates risks and removes bottlenecks throughout the biopharmaceutical process.

In this webinar, you will learn:
  • What are the benefits of using an optimized/engineered expression system?
  • What can be done throughout the cell line development process to mitigate risks and remove bottlenecks?
  • Applications of cell line engineering for further upstream biopharmaceutical enhancements.

A Molecule’s Journey – Breaking Down Roadblocks to Commercial Success

  • Presenter: Guillaume Plane, Marketing and Development Manager, Merck BioReliance® End-to-End Solutions
  • Date: Tuesday, December 5, 2017
  • Duration: 1 Hour
  • Session: 11:00 AM EST, 8 AM PST, 5 PM CET
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 Abstract:
Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. In this webinar, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment.

In this webinar, you will learn:
  • Key business considerations for commercial success
  • Key technical considerations
  • Regulatory and risk assessment considerations

Comprehensive Assessment of a Stimulus-Responsive Flocculation Polymer for Cell Culture Clarification

  • Presenter: Michael Susienka, Research Scientist III
  • Date: Thursday, December 7, 2017
  • Duration: 1 Hour
  • Session: 11:00 AM EST, 8 AM PST, 5 PM CET
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 Abstract:
This webinar will provide a comprehensive, holistic assessment of the effects of Clarisolve® mPAA flocculation polymer pre-treatment upon clarification and subsequent downstream chromatography steps.

Flocculation is a simple method to pre-clarify high density Chinese hamster ovary (CHO) cell culture feed streams, allowing for an efficient clarification process that would otherwise not be feasible using traditional depth filters. Clarisolve® mPAA polymer is a stimulus-responsive flocculation polymer that may provide a reduced dosing dependency and lower residual polymer levels when compared to other flocculants. Cell culture pre-treatment with Clarisolve® mPAA polymer followed by clarification using Clarisolve® 60HX depth filters, enables a significant increase of harvest throughputs and allows for a single clarification stage for these high-density feed streams. Furthermore, by eliminating the need for centrifugation, pre-treatment with Clarisolve® mPAA polymer allows for the implementation of a single-use clarification train.This webinar will review the efficacy of pretreatment with a range of Clarisolve® mPAA polymer concentrations upon the clarification and purification of a CHO cell culture feed stream. These results were compared to material prepared using conventional Millistak+® HC depth filtration media to deliver a comprehensive, holistic assessment of the effects of Clarisolve® mPAA polymer pre-treatment upon the clarification and subsequent downstream chromatography steps.

In this webinar, you will learn more about:
  • The effects of the Clarisolve® mPAA polymer pre-treatment on depth filtration capacity and soluble impurity removal
  • The impact of Clarisolve® mPAA polymer pre-treatment on downstream chromatography steps
  • Residual polymer clearance and detection

Overview of the Regulatory Landscape for Plastic Devices in Pharmaceutical Manufacturing

  • Presenters: Manjula Aysola, Regulatory Affairs Manager & Dr. Mattias Rheinheimer, Pharma and Food Subject Matter Expert
  • Date: Thursday, December 14, 2017
  • Duration: 1 Hour
  • Session: 11:00 AM EST, 8 AM PST, 5 PM CET
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 Abstract:
This webinar highlights regulations for plastic devices in pharmaceutical manufacturing, a risk-based approach to qualifying components, and the importance of regulatory documentation.

The growing complexity of therapeutics and globalization are some of the factors leading to innovative manufacturing solutions. Thanks to their flexibility and ease of use, polymeric materials are being used more frequently in the manufacturing of pharmaceuticals and biopharmaceuticals. Consequently, the development and qualification of plastic components requires a purposeful implementation of a multifaceted regulatory guidance. However, the lack of regulations specific to plastics used in pharmaceutical manufacturing systems has led to considerable uncertainty. 

In this webinar, you will learn:
  • Global regulations relevant to pharmaceutical manufacturing addressing biological reactivity, extractables, and food contact material
  • A risk-based approach to qualifying components for their intended use
  • The importance of documentation to support material qualification, risk assessment and process optimization

Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving Regulatory Environment

  • Presenter: Douglas Bowman, Emprove® Program Manager
  • Date: Thursday, January 18, 2018
  • Duration: 1 Hour
Session 1: 3:00 AM EST, 12 AM PST, 9 AM CET
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9:00–10:00 AM Paris
Brussels
12:30 PM–1:30 AM India
2:00–3:00 PM Indonesia
Thailand
Vietnam
3:00–4:00 PM China
Singapore
Taiwan
4:00–5:00 PM  Japan
Korea
12:00–1:00 AM San Francisco
3:00–4:00 AM New York

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Session 2: 11:00 AM EST, 8 AM PST, 5 PM CET
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This webinar will discuss appropriate quality attributes for different raw material uses, present strategies to support identification, selection and risk assessment of raw materials, and highlight the importance of regulatory documentation.

Recent and continuing regulatory improvements require drug manufacturers to assess and mitigate risk throughout their entire processes. This includes raw materials used at every stage of manufacturing and clinical phases. Current regulatory guidelines and industry standards clearly define quality requirements for raw materials that are incorporated into, or used close to, final drug product, for example active ingredients and excipients. However, no such clear standards are defined for chemicals used earlier in the process, such as in upstream bioprocessing, early chemical synthesis stages, or clean-in-place. The absence of such standards presents a challenge to efficiently and effectively source raw materials with appropriate supply chain transparency and control, accompanied by the necessary supporting documentation.

In this webinar, you will learn:
  • Strategies to support identification, selection, and risk assessment of raw materials throughout the manufacturing process
  • Appropriate quality attributes for different raw material uses
  • The importance of quality and regulatory documentation provided by the supplier