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Excipients & Upstream/Downstream Manufacturing Processes in Biologic Drug Products

Description



The growth in biologic drug development has been dramatic in the last 10 years and is set to continue in the future. Excipients are used in both upstream / cell culture and downstream / formulation processes and this webinar will discuss their use in both areas and will highlight the importance of excipient purity.


This webinar will include 2 hours of interactive presentations. We have invited academic, industry, and regulatory experts to provide different perspectives. We will allot approximately 35 minutes for each presenter. Discussion and Q&A will be encouraged throughout.

The topics that will be discussed are:

Francis Kinderman, PhD, Amgen Inc.
Topic: The Role of Excipients in the Storage and Administration of Biologics

Supriyadi Hafiz, M.Sc., Merck KGaA
Topic: Improving Protein Purification: Application of Excipients in Downstream Processing


Mr. Ross Blezard, DFE Pharma
Topic: Importance of Disaccharide Excipients in Biologics

Contributors

  • Dr. Francis Kinderman, PhD

    Francis obtained his bachelor’s degree from University of California Los Angeles, where he studied biochemistry, and his Ph.D. from University of California San Diego, also in biochemistry. He joined Amgen in 2006 in the Analytical Sciences department, where he focused on analytical method development, biophysical characterization, and studying the biological relevance of quality attributes for various large molecule modalities. Now he works in Drug Product Technologies where he leads a team engaged in formulation development and drug product process development for multiple pipeline programs. In addition to project support, Francis conducts research studying the impact of product attributes on the bioavailability of subcutaneous injections.

  • Mr. Supriyadi Hafiz, M.Sc.

    Supriyadi Hafiz, M.Sc. Senior Scientist Formulation, Active & Formulation in the Process Solutions, Life science division of Merck KGaA, Darmstadt, Germany is with the company for 8 years, working in development of excipients for downstream processing and protein final formulations. Hafiz has a BS in Biotechnology from Esslingen University Applied Sciences and a MS in Biosystem Technology from Darmstadt University of Applied Sciences.

  • Mr. Ross Blezard

    Ross Blezard is a physicist by education, graduating from the University of Surrey, UK in 2008. He has worked across multiple industries including defense, food and Pharmaceuticals. He was previously Head of Formulation Development at a UK based CDMO and has a broad range of experience, with a focus on respiratory, topical and transdermal dosage forms.

    Ross joined DFE Pharma in 2019 as product application specialist supporting the inhalation and BioHale product ranges.


Thank you for supporting the Excipient World Academy.
June 30, 2021
Wed 11:00 AM EDT

Duration 2H 0M

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