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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

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

Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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

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Headline News

Ubamatamab produces high rate of durable responses in early study of advanced low grade serous ovarian cancer


ICOTYDE maintains high skin clearance rates through two years in plaque psoriasis


Taltz plus Zepbound shows broader biomarker effects in psoriasis and obesity study


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Upcoming Webinars

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Past Webinars

Affinity Chromatography for Vaccines Purification

Presented by Mikkel Nissum, Vaccine R&D Quality Site Lead at GSK Vaccines
12th May 2020


Potential use of handheld Raman devices as tools for screening medicines for quality

Presented by Dr. Patrick Lukulay & Dr. Mustapha Hajjou
08th June 2015


Extractables and leachables testing using a Quality Risk Management approach

Presented by Dhaval Tapiawala, Principal Scientist at Pfizer and Satish Kumar Mohanvelu, Life Sciences Management Professional at MilliporeSigma
17th October 2018


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