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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

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

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

Navigating Technology Transfer

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

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Headline News

Roche highlights divarasib, giredestrant and Tam-Peli data ahead of ESMO 2026


FDA approves Enspryng as first at-home subcutaneous treatment for thyroid eye disease


CHMP backs extended Libtayo dosing schedule across approved EU cancer indications


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Upcoming Webinars

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Past Webinars

A risk based approach to continuous processing

Presented by Rob Bowen, Chair of the UK Central Region of ISPE and co-chair of the ISPE HVAC and Sustainable Facilities Community of Practice.Process Architect and Director,Facilities Integration
14th May 2015


Fully continuous biosimilar manufacturing framework: A case study

Presented by Samir Varma, Head of Manufacturing, Enzene Biosciences and Lotta Molander, Global Product Manager, GE Healthcare
14th June 2018


Overcoming Antibody-Drug Conjugate (ADC) Process Development & Manufacturing Challenges

Presented by Dr. Jimmy Li, CEO of WuXi XDC (a WuXi Biologics subsidiary)
23rd February 2022


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