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

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

Volume Reduction and Process Optimization with Cadence Inline Concentrator

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

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

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Headline News

Alexion strengthens research leadership in gMG care with new data at 2026 AANEM Annual Meeting and MGFA Scientific Session


Novo Nordisk secures exclusive global license from Hengrui Pharma for once-weekly oral GLP-1/GIP dual agonist HRS-1596


Perioperative Imfinzi combined with neoadjuvant enfortumab vedotin secures Priority Review status in the US for muscle-invasive bladder cancer patients


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Upcoming Webinars

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Past Webinars

Preview of USP’s Informational Chapter <1085>, “Guidelines on the Endotoxins Test”

Presented by Karen Zink McCullough & Kevin L. Williams
11th June 2018


Implementing CMC Strategies for scale-up operations in biologics manufacturing

Presented by Dr Anita Krishnan, Assistant Director, Head, CMC development at Lupin and Dr. Annu Uppal Manager Biopharmaceutical Applications at AB SCIEX
05th October 2018


From Early Stage to Late Stage Development: How to Characterize a Perfusion-based Vaccine Production Process Using QbD?

Presented by Perrine Rouel, Scientist - Up Stream Processing, The Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Application Specialist – Ambr Technology KAM Europe at Sartorius Stedim Biotech
27th March 2019


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