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Application of Quality Risk Management to Process Validation

Robert Dream, Managing Director, HDR Company LLC

A Holistic Phase Appropriate Strategy for HCP-Limits and HCP Characterization

Dr. Markus Haindl, Global Head Gene Therapy Technical Research & Development, Roche Di...

Strategies for Extractable and Leachable Risk Assessment of Polymeric Single Use Systems U...

Ping Wang, Director, Johnson & Johnson

Use of Non-Contact Raman Spectroscopy to Derive Reaction Kinetics

Richard Hart, Senior Director – Head of Automation and Data Science (Previously Asso...

Amsphere A3

JSR Life Sciences


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Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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Novel Synthetic Adsorptive Depth Filter Media for CHO Harvest Clarification

John Amara, Ph.D. and Michael Dullen Merck, 80 Ashby Road, Bedford, MA, 01730, USA

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Headline News

Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


FDA approves subcutaneous SKYRIZI induction regimen for Crohn’s disease


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Upcoming Webinars

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Past Webinars

Application of USP 665 data to support qualification of single use systems

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia and James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
01st September 2020


UNICAN: Dual capability in single use bioreactors

Presented by Presented by Ekta Mahajan, Senior. Regulatory Program Director at Genentech
13th October 2022


From Early Stage to Late Stage Development: How to Characterize a Perfusion-based Vaccine Production Process Using QbD?

Presented by Perrine Rouel, Scientist - Up Stream Processing, The Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Application Specialist – Ambr Technology KAM Europe at Sartorius Stedim Biotech
27th March 2019


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