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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

Bringing the Freezing of Biopharmaceuticals in From the Cold

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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

AbbVie’s Temab-A receives two FDA Breakthrough Therapy Designations in colorectal and lung cancer


FDA approves Rhapsido as first treatment for symptomatic dermographism


Vamikibart shows sustained one-year vision improvements in Phase III uveitic macular edema studies


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Upcoming Webinars

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Past Webinars

CCAB: Addressing the risk of microbial impurities in Biologics and certain Advanced Therapy Medicinal Products (ATMPs)

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST (individual Neoepitope Specific Therapy), Roche and Nahuel Paolini, PhD, Sanquin Reagents
28th March 2022


Orthogonal Measures of Lentiviral Particle Attributes Using DLS, NTA, and Micro Flow Cytometry

Presented by Jim Richardson, Senior Director, Analytical Development at Interius Biotherapeutics and Kevin Lance, PhD, Director of Analytics Marketing at Unchained Labs
16th February 2023


Future Trends To Control Risks From Extractables and Leachables

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Kathleen Lava PhD – E&L Expert Nelson Labs Europe
09th February 2021


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