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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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Headline News

FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study


Onchilles reports early systemic activity with intratumoral N17350 in Phase I/II trial


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Advances in the Purification of Antisense Oligonucleotides

Presented by Robert Gronke, Ph.D., Senior Principal Scientist, Technical Development, Biogen and John Cyganowski, Director of Customer Application, Downstream, Merck
27th October 2021


Material Requirements to Support Gene Therapy Development

Presented by Clare Blue, Director of Analytical Development at Biogen and James Wilkinson, VP of Sales and Customer Success at Refeyn
19th May 2022


Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieux
23rd May 2019


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