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

Bringing the Freezing of Biopharmaceuticals in From the Cold

Bristol Myers Squibb adopts positive CHMP opinion for Opdivo plus Yervoy for patients with Microsatellite instability high or mismatch repair deficient metastatic colorectal cancer

Bristol Myers Squibb

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

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Headline News

Perioperative Imfinzi combined with neoadjuvant enfortumab vedotin secures Priority Review status in the US for muscle-invasive bladder cancer patients


Novo Nordisk secures exclusive global license from Hengrui Pharma for once-weekly oral GLP-1/GIP dual agonist HRS-1596


FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications


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Upcoming Webinars

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Past Webinars

Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins

Presented by Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca & Piet Christieans, PhD, Scientific Director at Nelson Lab
14th May 2020


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


The New Annex 1 Revision And The Impact on Using Rapid Methods For Environmental Monitoring

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC
02nd September 2020


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