Current Issue

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

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

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

Monica Cardona and Ian Johnson Pall Life Sciences

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

Pall Corporation

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Headline News

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


Moderna advances Bundibugyo ebolavirus vaccine toward Phase II/III study


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

Can the New generation of perfusion technology compete or replace the conventional and widely preferred fed-batch technology?

Presented by Ankur Bhatnagar, Chief Scientific Manager of Biocon R&D
15th November 2017


Development and Implementation of Intensified Bioprocessing for Biologics Manufacturing

Presented by Hang Zhou, Ph.D., Vice President, Head of Cell Culture Process Development Biologics and Bioprocess Dept. at WuXi Biologics
12th March 2021


Material Understanding for Continuous Manufacturing of Solid Dosage Forms

Presented by Dr Yifan Wang, Regulatory Research Scientist, FDA CDER and Dirk Leister, Leader Technical Marketing Thermo Fisher Scientific
23rd August 2018


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