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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

Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)

Pall Corporation

Volume Reduction and Process Optimization with Cadence Inline Concentrator

Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies

Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington

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Headline News

IMAAVY maintains disease control through two years in adolescents with generalised myasthenia gravis


Foundayo linked to lower predicted long term diabetes and cardiovascular risk in ATTAIN 1 analysis


Zumilokibart meets primary endpoint in Phase II atopic dermatitis study


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Upcoming Webinars

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Past Webinars

The Journey to Lean Implementation for Efficiency Increase

Presented by Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche
04th September 2019


Host Cell Protein Characterisation and Mass Spectrometry Strategies

Presented by Xuezhi Bi, Group Leader (Proteomics) /Senior Scientist at Bioprocessing Technology Institute, A*STAR
19th February 2019


FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing

Presented by Lily Koo, Consumer Safety Officer at Food and Drug Administration and Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech, Analytics Lead
16th October 2019


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