Current Issue

Establishing Standards and Methods for Qualification and Validation of New Particle Measur...

Srivalli N. Telikepalli, Research Chemist Dean C. Ripple, Supervisory Physicist Kurt D. Be...

Case Study and Experience in Extractable and Leachable Studies of Plastic Process Material...

Dujuan Lu Manager/Global Lead – Extractable and Leachables SGS Life Sciences

An Introduction to Rapid Microbiological Methods: Regulatory Acceptance, Validation and Im...

Michael Miller, President Microbiology Consultants LLC



Headline News

$24 Million to be Invested by Thermo Fisher Scientific to Increase Global Bioproduction Capabilities


Sanofi Announces FDA Approval for Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for adults 65 years of age and older


In Order to Simplify Manufacturing Supply Chain for Advanced Therapies, Vineti and WuXi AppTec Collaborate


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Upcoming Webinars

Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materials Used in Biologics Production

Presented by Ping Wang, Director at Johnson & Johnson and Donald F. DeCou, Ph.D, Extractables and Leachables Technology Manager at West Pharmaceutical Services
23rd March 2020


Machine Learning in Bioprocess Development: Where We Are and Where We Could Go

Presented by Moritz von Stosch, PhD, Senior Manager, Technical R&D, GlaxoSmithKline Vaccines and Klaus Mauch, CEO at Insilico Biotechnology AG
06th May 2020


Harnessing the Power of Data Analytics to Derive Process Intelligence for Pharma Manufacturing

Presented by Santosh Whatkar, Senior Manager, Automation and Digital Technology at Pfizer
05th March 2020


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Past Webinars

Extractable Study Design and Data Evaluation of Polymeric Product Contact Materials

Presented by Dr. Ping Wang, Principal Scientist, Janssen R&D and Dr Nixdorf, SGS Group
05th June 2018


Do Extractable Protocols Truly Help – An End User Perspective

Presented by Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for Extractables & Leachables at Central Analytics of Merck KGaA, Darmstadt Germany
08th May 2019


Patient-Centric Drug Delivery Strategies For Oral Paediatric Products

Presented by Dr. Carsten Timpe Senior Principal Scientist at Hoffman La Roche AG and Dr. Paolo Gatti Research Fellow and Formulation Manager for Aptalis Pharmaceutical Technologies
22nd April 2015


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