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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

A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

Navigating Technology Transfer

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

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Headline News

FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications


AstraZeneca commits $2 billion to Summit Therapeutics as part of new equity stake and cancer research alliance centered on antibody drug conjugate combinations


EMPAVELI reduces proteinuria and stabilises kidney function in adolescents with C3G or primary IC MPGN


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Upcoming Webinars

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Past Webinars

How to Utilize Design of Experiments (DoE) Principles for the Development of High Throughput, Robust Methods for the Assessment of Product Quality

Presented by Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca
19th September 2019


Case Study: CMC Biologics Explores the Potential of Continuous Multi-Column Chromatography

Presented by Michelle Najera, PhD, CMC Biologics, Downstream Process Development Scientist and Lynne Frick, Director of Sales, Continuous Bioprocessing, Pall Life Sciences
06th February 2017


Quality-By-Design in Spray Drying Processes – Transfer Lab to Production

Presented by Sune Klint Andersen at Janssen Pharmaceutical Companies of Johnson & Johnson and João Vicente Senior Scientist - Particle Engineering Team Leader at Hovione
19th February 2019


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