Current Issue

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

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

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

Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

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Headline News

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


CAPLYTA shows rapid improvement in bipolar mania in second pivotal Phase III study


Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


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Upcoming Webinars

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Past Webinars

The Journey to Lean Implementation for Efficiency Increase

Presented by Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche
04th September 2019


Next Generation Bioprocess Facility Design – A Case Study From Samsung Biologics

Presented by Ken Green, Ph.D, Head of Manufacturing, Science and Technology at Samsung Biologics and John Bonham-Carter. Product Line Leader, Cell Culture & Clarification Business, Repligen
26th October 2020


Batch to Continuous Technology: The Journey from Laboratory to Pilot Scale for DS Manufacturing

Presented by Jörg Sedelmeier, Platform Leader: Continuous flow technology (Principal Scientist) at Roche
26th September 2022


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