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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

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

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

Enabling Total Biopharma Solutions

Pall Life Sciences

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

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Headline News

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


FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


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


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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


Real-time Sequencing by FTIR in GMP Oligonucleotide Synthesis

Presented by John-David McElderry, Scientist at Biogen and Dominique Hebrault, Science & Technology Business Development at Mettler-Toledo International, Inc
04th March 2020


From Concept to Market – Unique approaches in Biomanufacturing

Presented by Jincai Li, Vice President of WuXi Biologics and Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
18th September 2019


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