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
Navigating Technology Transfer
Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies
Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington
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
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
View All Featured ArticlesHeadline News
Roche launches VENTANA BAP1 test to support mesothelioma diagnosis
Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI
FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy
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Upcoming Webinars
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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
Path to Smart Manufacturing and Intelligent Development within Industry 4.0 – Building an Integrated Sensing Strategy
Presented by Dan Hill, Associate Director, Digital Development & Analytics, Product & Technology Development at Biogen and Chris McCready, Lead Data Scientist at Sartorius Stedim Biotech and Martin Gadsby, Vice President , Optimal Industrial Technologies Ltd
20th September 2022
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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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
Rationale Design of Valves for Flexible Processing
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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