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...
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Featured Articles
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma
Novel Synthetic Adsorptive Depth Filter Media for CHO Harvest Clarification
John Amara, Ph.D. and Michael Dullen Merck, 80 Ashby Road, Bedford, MA, 01730, USA
Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification
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Novo Nordisk’s once-weekly Sogroya receives positive CHMP opinion in Europe for children with idiopathic short stature
FDA approves Kerendia for chronic kidney disease linked to type 1 diabetes
CHMP recommends EU approval of FREHEMGO as the first factor VIIIa mimetic to offer monthly, biweekly, and weekly dosing through a pre-filled pen for haemophilia A treatment
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Upcoming Webinars
View All Upcoming WebinarsPast Webinars
Validation of Microbiological Methods – Expectations for Regulatory Compliance
Presented by Dr. Rajesh K. Gupta Scientific & Compliance Consultant and Alan Hoffmeister, Global Field Technical Manager for Charles River
22nd May 2015
Preview of USP’s Informational Chapter <1085>, “Guidelines on the Endotoxins Test”
Presented by Karen Zink McCullough & Kevin L. Williams
11th June 2018
Rapid Microbiology Applications in the COVID-19 Era
Presented by Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC, Ulrich Herber Director of Technology and Market Development Charles River and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
04th August 2020
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Featured Companies
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Featured Video
At Pall we help you select the process model that’s perfect for you. Ensuring it’s adapted to meet your precise needs and assembled flawlessly, ready for the future, from day one.
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Technical Papers
From Compliance to Circularity: Three Ways Pharma Manufacturers Can Rethink Resource Management
Lifetime study for JSR Amsphere A3 – protein A resin
Best Practices for Achieving Virus Safety
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Featured Products
Decrease Cleaning Validation Time and Resources
AdvantaPure
Amsphere™ A3 Protein A Resin – JSR Life Sciences
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