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

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

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.

Coupling single-pass TFF before loading onto a chromatography sorbent

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Headline News

Incyte reports new KRAS G12D and bispecific antibody data across pancreatic and colorectal cancer


FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting


RYBREVANT FASPRO combination shows 77% response rate in first-line advanced head and neck cancer


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Upcoming Webinars

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Past Webinars

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


Safety Evaluation on Extractables and Leachable

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Tino Otte, Head of Sales & Consulting at Intertek
25th October 2022


The Common Road to Quality for Single Use Materials

Presented by Trishna Ray-Chaudhuri, PhD, Principal Technical Manager, Genentech- A Member of the Roche Group and Donald Young, Sr. Product Manager at Thermo Fisher Scientific and Marcus Bayer, Market Segment Manager Single Use at Hamilton
21st April 2021


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