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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

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Featured Articles

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

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

Continuous processing optimization with smarter tools

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

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

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


FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


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Upcoming Webinars

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Past Webinars

New Drug Product Development Using Continuous Manufacturing

Presented by Giustino Di Pretoro, Associate Director Drug Product Development an Johnson and Johnson And Dr. Robin Meier, Manager Scientific Operations at L.B. Bohle Maschinen
28th May 2019


UNICAN: Dual capability in single use bioreactors

Presented by Presented by Ekta Mahajan, Senior. Regulatory Program Director at Genentech
13th October 2022


The New Annex 1 Revision And The Impact on Using Rapid Methods For Environmental Monitoring

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC
02nd September 2020


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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

Strategy Emerging Markets for Risk Mitigation


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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