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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Changing Column Packing from an Art into a Science

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.

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

GSK’s Jemperli wins FDA approval as first immunotherapy for MSI-H/dMMR locally advanced rectal cancer


Gilead extends lenacapavir licensing deals to cover investigational once yearly HIV prevention shot


Gilead to present 28 abstracts on HIV treatment, prevention and emerging antiviral research at IDWeek 2026


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Upcoming Webinars

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Past Webinars

Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Blend Homogeneity in Continuous Manufacturing

Presented by Anders Sparén, Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI Solutions
03rd March 2020


Engineering First Principles: Applications to Pharmaceutical Manufacturing

Presented by Bernard McGarvey, PhD Chemical Engineering
05th November 2019


Regulatory Strategies and Case Studies 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
23rd May 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

Amsphere TM A3


Strategy Emerging Markets for Risk Mitigation


Lifetime study for JSR Amsphere A3 – protein A resin


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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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