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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

Navigating Technology Transfer

Bringing the Freezing of Biopharmaceuticals in From the Cold

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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Headline News

FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


Nipocalimab Sjögren’s data highlight symptom improvements most valued by patients


Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


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Upcoming Webinars

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Past Webinars

Effect of Cell Culture Process Change from Fed-batch to Continuous on Productivity and Product Quality

Presented by Ru Zang, Associate Director at Mersana Therapeutics and John Bonham Carter, Product Line Lead, Cell Culture and Clarification Business at Repligen
25th February 2019


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


New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical Manufacturing Process

Presented by Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche and Mathilde Arnault, Research Scientist, BioMonitoring R&D, Merck KGaA, Darmstadt, Germany
09th April 2019


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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

Rationale Design of Valves for Flexible Processing


Amsphere TM A3


Column Packing Protocol for Amsphere 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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