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

Continuous processing optimization with smarter tools

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

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

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

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

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Headline News

FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


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Upcoming Webinars

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Past Webinars

Qualification of Raw Materials and Cell Substrates for Biomanufacturing

Presented by Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia and Martin Wisher, PhD, Global Head of Regulatory Affairs at Merck
16th January 2020


New Drug Product Development Using Continuous Manufacturing

Presented by Giustino Di Pretoro, Associate Director Drug Product Development an Johnson and Johnson And Dr. Robin Meier, Manager Scientific Operations at L.B. Bohle Maschinen
28th May 2019


Impact of Depth Filtration on Disulfide Bond Reduction during Downstream Processing of Monoclonal Antibodies from CHO Cell Cultures

Presented by Brian O' Mara, Senior Research Scientist I at Bristol-Myers Squibb and Alexei Voloshin, Global Application Strategy Specialist at 3M Separation and Purification Sciences Division
08th October 2018


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