Current Issue

Advanced Therapy Medicinal Products Technology Transfer Challenges – Part 3

Robert Dream, Managing Director, HDR Company LLC

Advances and Challenges in Vaccine Development and Manufacture

Tony D’Amore, Ph.D. MBA, Board Member, Scientific Advisor and Independent Consultant for...

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler, Associate Vice President, Process Development, Amgen (previously Associate ...

Current Trends in Control and Monitoring of Subvisible Particulate Matter in Biotherapeuti...

Satish (Kumar) Singh, Vice President, Drug Product Development, Astria Therapeutics, Inc. ...

Lifetime Study for JSR Amsphere A3 – Protein A Resin

JSR Life Sciences


Featured Articles

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

James Barry, Director of Marketing, Americas, Pall Biotech

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

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Headline News

FDA grants Priority Review to Takeda’s zasocitinib for moderate to severe plaque psoriasis


Roche partner MediLink reports Phase III data showing Tam-Peli significantly extends survival in Chinese small-cell lung cancer patients


FDA grants Priority Review to efzimfotase alfa for patients with hypophosphatasia aged two and older


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Upcoming Webinars

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Past Webinars

Janssen’s Real Time release: Using MSPC to enhance batch release.

Presented by Sarah Nielsen, Director of Process Science at Janssen and Herman He, Senior Applications Scientist at Thermo Fisher Scientific
15th September 2021


Raw Material Sourcing and Qualification

Presented by Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC
23rd November 2020


Extractables and Leachables have been used interchangeablely for too long. Are we still confused?

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West Pharmaceutical Services
25th March 2019


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