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

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

James Barry, Director of Marketing, Americas, Pall Biotech

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

Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

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Headline News

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


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


Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


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Upcoming Webinars

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Past Webinars

ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics.

Presented by Jason Creasey, Managing Director at Maven E&L Ltd, Piet Christiaens, PhD, Scientific Director and Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director at Nelson Labs
14th September 2022


Extractable and Leachable Study Design For Disposables

Presented by Ken Wong, Deputy Director, MTech/AP&T - Extractables & Leachables at Sanofi Pasteurand Jerry Martin, Sr. Vice President, Global Scientific Affairs for Pall Life Sciences
11th February 2015


FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing

Presented by Lily Koo, Consumer Safety Officer at Food and Drug Administration and Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech, Analytics Lead
16th October 2019


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