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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

Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma

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

Bringing the Freezing of Biopharmaceuticals in From the Cold

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

FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


Lilly highlights retatrutide, Taltz and Zepbound data across rheumatologic diseases and obesity


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


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Upcoming Webinars

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Past Webinars

NIR In-Line Monitoring for Drug Product Continuous Process: From Understanding to Control

Presented by Yang (Angela) Liu
19th January 2016


Sanofi’s Journey & Strategy for Continuous Processing for Small Molecules

Presented by Flavien Susanne, Head of Chemical Development and Engineering at Sanofi and Sean Bermingham, Head of Formulated Products at PSE Ltd
27th September 2021


We Are Going Back to the Future with Rapid Methods.

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Félix Montero-Julian, Scientific Director at bioMérieux
14th February 2022


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