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

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

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

Enabling Total Biopharma Solutions

Pall Life Sciences

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

Health Canada authorizes Moderna’s mRNA flu and combination flu-COVID vaccines


Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial


Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


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Upcoming Webinars

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Past Webinars

Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
07th March 2022


Single Use Manufacturing within the Bristol-Myers Squibb Manufacturing Network – Preparing for Commercial Production

Presented by Lance Marquardt, Associate Director - Upstream Processing for Hopewell Clinical Manufacturing at Bristol-Myers Squibb and  Sara Bell, Senior Marketing Manager for Merck’s single-use product portfolio
17th January 2019


A risk based approach to continuous processing

Presented by Rob Bowen, Chair of the UK Central Region of ISPE and co-chair of the ISPE HVAC and Sustainable Facilities Community of Practice.Process Architect and Director,Facilities Integration
14th May 2015


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Featured Companies

 

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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

Amsphere TM A3


Caustic Stability of Amsphere A3 : Cycling Study with 0.5 M NaOH


Rationale Design of Valves for Flexible Processing


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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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