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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

Bringing the Freezing of Biopharmaceuticals in From the Cold

A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor

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

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


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


FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks


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Upcoming Webinars

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Past Webinars

Utilizing Cell Culture Platform and High-Throughput Bioreactors to Streamline Upstream Process Development and manufacturing scale up

Presented by Sanjeev Gupta, Ph.D., Vice President and Head Advanced Biotech (Biosimilar Division), Ipca Laboratories Ltd., Mumbai-India
15th November 2022


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


The Paperless Laboratory: A Way Into Process Optimisation

Presented by Peter Boogaard
05th November 2015


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