Current Issue

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

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

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

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

Volume Reduction and Process Optimization with Cadence Inline Concentrator

Bringing the Freezing of Biopharmaceuticals in From the Cold

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Headline News

FDA clears Jaypirca as first line treatment for certain previously untreated CLL and SLL patients


Giredestrant and everolimus significantly extend progression free survival in ER positive advanced breast cancer in phase III evERA results published in The New England Journal of Medicine


Sanofi and Regeneron bring four new long acting antibodies into Dupixent partnership in deal worth up to $8 billion


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Upcoming Webinars

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Past Webinars

Safety Evaluation on Extractables and Leachable

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Tino Otte, Head of Sales & Consulting at Intertek
25th October 2022


Just in Time Release of CAR T Cell Therapies

Presented by Irving Ford, Head of CAR T QC Laboratories at Celgene and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
11th November 2019


Modernizing Biopharmaceutical Manufacturing: from Batch to Continuous Production

Presented by Robert Dream, PE, CPIP, of HDR Company, LLC
19th July 2017


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