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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...

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JSR Life Sciences


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

Overcoming Obstacles in AAV Viral Vector Manufacturing

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Monica Cardona and Ian Johnson Pall Life Sciences

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

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Headline News

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


Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial


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Upcoming Webinars

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Past Webinars

Handling mutagenic extractable and leachable compounds released from devices

Presented by Ron Brown, Toxicologist at Risk Science Consortium and Piet Christieans, PhD, Scientific Director at Nelson Labs
10th February 2022


Case Study and Experience on Sanofi’s and SGS’s Implementation of BPOG’s Leachable Risk Assessment Model

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGS
10th September 2019


Orthogonal Measures of Lentiviral Particle Attributes Using DLS, NTA, and Micro Flow Cytometry

Presented by Jim Richardson, Senior Director, Analytical Development at Interius Biotherapeutics and Kevin Lance, PhD, Director of Analytics Marketing at Unchained Labs
16th February 2023


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