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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

Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)

Pall Corporation

Volume Reduction and Process Optimization with Cadence Inline Concentrator

Navigating Technology Transfer

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

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


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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Upcoming Webinars

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Past Webinars

Biopharmaceutical process development – Trends/ Challenges/Opportunities

Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and  Validation Consulting group at Pall Biotech
20th November 2019


Continuous Capture and Continuous Recovery – Novel Ideas for Product Recovery from Perfusion Process Using ATF

Presented by Dr. Kerstin Lange, Team Lead Process Technology and Innovation, Advanced Bioprocessing, Andrew Falconbridge Vice President Process Technology and Innovation, Alvotech and Earl Pineda Sr. Manager, Upstream Field Applications EU/APAC at Repligen
03rd February 2021


Raman Spectral Library for Counterfeit Detection

Presented by Dr. Jason Rodriguez, FDA Division of Pharmaceutical Analysis (DPA) and Dr. Katherine A. Bakeev, Director of Analytical Services and Support for B&W Tek
18th March 2015


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