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

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification

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

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.

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Headline News

AstraZeneca finalises $2 billion stake in Summit Therapeutics to speed up ivonescimab combination research


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


Ubamatamab produces high rate of durable responses in early study of advanced low grade serous ovarian cancer


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Upcoming Webinars

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Past Webinars

Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe
03rd February 2020


Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Kevin L. Williams, Microbiological Test Development at bioMérieux, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza 
02nd February 2023


Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control & Benefits of Cartridge Technology

Presented by Dr. Zlatibor Velickovic PhD Production Manager | Department of Cell & Molecular Therapies, Royal Prince Alfred Hospital Sydney, Australia, ISCT Regional Vice-President Elect, Australia & New Zealand and Alan Hoffmeister Senior Global Technology & Market Development Manager, Charles River Laboratories
28th October 2021


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Featured Video

At Pall we help you select the process model that’s perfect for you. Ensuring it’s adapted to meet your precise needs and assembled flawlessly, ready for the future, from day one.

There’s no kit for the perfect biotech process. Until now.

 

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Technical Papers

Best Practices for Achieving Virus Safety


Lifetime study for JSR Amsphere A3 – protein A resin


Amsphere TM A3


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Featured Products

Decrease Cleaning Validation Time and Resources


AdvantaPure


Amsphere™ A3 Protein A Resin – JSR Life Sciences


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