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From Aberrant Results to Alternative Methods: Strengthening Pharmaceutical Laboratory Deci...

Dr Markus Funk, Operations Director Analytics Axel. H. Schroeder, Operations Director Micr...

Sterility Assurance – An Enabler to Comply with Annex 1

Robert Dream, Managing Director, HDR Company LLC

Harmonization of Viral Segregation Strategy for a Manufacturing Network with Multiple Faci...

Bonnie K. Shum, Senior Director, Product Technical Leader, Genentech

Raw Material Qualification – A Practical Approach

Aurora Henry, GMP Quality/ Raw Material Quality/Material Control Leader

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

JSR Life Sciences


Featured Articles

Novel Synthetic Adsorptive Depth Filter Media for CHO Harvest Clarification

John Amara, Ph.D. and Michael Dullen Merck, 80 Ashby Road, Bedford, MA, 01730, USA

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Continuous processing optimization with smarter tools

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

Characterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor

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Headline News

Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study


Andelyn partners with Celliaz to manufacture AAV gene therapy for retinitis pigmentosa


CHMP recommends Gazyva/Gazyvaro for systemic lupus erythematosus


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Upcoming Webinars

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Past Webinars

Annex 1 and Environmental Monitoring Program – Implementation And Justification of The Best Practices In Routine

Presented by Presented by Benoit Ramond, Head of Microbiology & Sterile Technology at Sanofi and Laurent Leblanc, 3P Ecosytem R&D Manager at bioMérieux
19th October 2022


Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century

Presented by Presented by Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and  Dr. David Jones, Director of New Products & Industry Affairs at Rapid Micro Biosystems
12th September 2019


Application of USP 665 data to support qualification of single use systems

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia and James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
01st September 2020


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