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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


Featured Articles

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Changing Column Packing from an Art into a Science

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Monica Cardona and Ian Johnson Pall Life Sciences

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Headline News

Körber certifies ZETA’s INOSIM Foresight for PAS X MES data integration


TECVAYLI plus DARZALEX FASPRO modelling suggests longer survival in early line relapsed multiple myeloma


FDA approves Kerendia for chronic kidney disease linked to type 1 diabetes


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Upcoming Webinars

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Past Webinars

A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at Roche and Shabnam Solati, CEO & Co-Founder at CTL-MAT
16th September 2020


Exosome Manufacture Based on the iCELLis® Bioreactor Platform

Presented by David Haylock, CEO VivaZome Therapuetics and Roberto Ciboldi, Senior Scientist, Purification Team, Scientific & Laboratories Services Pall Corporation
11th May 2021


Novel Technologies That Aid the Detection and Differentiation of Proteinaceous Impurities in Biologic Drug Substances and Drug Product

Presented by Danny Chou, President and Founder at Compassion BioSolution, LLC
30th November 2020


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