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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

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

Bristol Myers Squibb adopts positive CHMP opinion for Opdivo plus Yervoy for patients with Microsatellite instability high or mismatch repair deficient metastatic colorectal cancer

Bristol Myers Squibb

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

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

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

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Headline News

Onchilles reports early systemic activity with intratumoral N17350 in Phase I/II trial


Regeneron CIDEBsiRNA delivers up to 80% liver fat reduction in early MASLD study


Camzyos shows sustained benefit through 56 weeks in paediatric obstructive HCM


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Upcoming Webinars

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Past Webinars

Integrity Assurance for Single-Use Systems: End-User Perspective

Presented by Charlotte Masy, Senior Manager in Manufacturing Science and Technology GSK vaccines and Patrick Evrard, Senior Principal Engineer, Single-Use Technologies in Technical Communication and Regulatory Strategy, Pall Corporation
06th October 2021


Digital Transformation Strategy Development in Biologics Manufacturing: One site’s journey

Presented by Robert Dimitri, Associate Director, Digital and Data Sciences Lead at Takeda and Toni Manzano, PhD, Chief Science Officer, Bigfinite
01st October 2020


Single-Use & Stainless Steel BioReactors: Quality Factors for Consideration When Selecting a Suitable System

Presented by Dr Trevor Deeks, Principal and Consultant of Deeks Pharmaceutical Consulting Services, LLC
08th November 2017


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