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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

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

James Barry, Director of Marketing, Americas, Pall Biotech

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

Coupling single-pass TFF before loading onto a chromatography sorbent

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Headline News

Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


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Upcoming Webinars

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Past Webinars

Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT Advanced Analytical Technologies to Monitor Critical Quality Attributes.

Presented by Dejan Arzenšek, Principal Scientist at Novartis and Justin Moretto, Life Science Product Marketing Manager at Kaiser Optical Systems, Inc
06th September 2021


Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing

Presented by Aaron Mack, Engineer at Biogen and Dave Kolwyck, Director Materials Science at Biogen and David Gemmell Senior Process Engineer at Merck
17th October 2019


Hybrid Models: The Best of Both (Mechanistic & Empirical) Worlds to Accelerate and De-Risk Process Development

Presented by Christian Airiau, PhD, Global Head Data Sciences, Biologics Development at Sanofi and Chris McCready, Lead Data Scientist at Sartorius Stedim Biotech
16th March 2021


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