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
Endotoxin Control Strategies for Parenteral Drug Product Manufacturing
Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA
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
Single-Use-Systems: Leachable Study Design for Single-Use Components
Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb
Overcoming Obstacles in AAV Viral Vector Manufacturing
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Mo-Rez shows 62% response rate in platinum-resistant ovarian cancer
FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting
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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Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing
Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Kevin L. Williams, Microbiological Test Development at bioMérieux, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza
02nd February 2023
Digital Transformation Strategy Development in Biologics Manufacturing: One site’s journey
Presented by Robert Dimitri, Associate Director, Digital and Data Sciences Lead at Takeda and Toni Manzano, PhD, Chief Science Officer, Bigfinite
01st October 2020
Using In-Vitro Dissolution to Support Post Approval Changes Global Regulatory Expectations
Presented by Xin Bu, Principal Scientist at Bristol-Myers Squibb
05th February 2019
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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
Lifetime study for JSR Amsphere A3 – protein A resin
Column Packing Protocol for Amsphere A3
Strategy Emerging Markets for Risk Mitigation
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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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