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
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
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
Volume Reduction and Process Optimization with Cadence Inline Concentrator
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ICOTYDE maintains skin clearance through two years in difficult to treat plaque psoriasis
Foundayo linked to lower predicted long term diabetes and cardiovascular risk in ATTAIN 1 analysis
FDA expands CAMZYOS approval to paediatric patients with obstructive hypertrophic cardiomyopathy
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Upcoming Webinars
View All Upcoming WebinarsPast Webinars
Key components of a comprehensive program for the management of single use technologies in biologics manufacturing
Presented by John Maguire, Shire and Donald Young, ThermoFisher Scientific
18th July 2018
New Paradigm of Building Quality during Manufacture – Challenges with Biological Products
Presented by Dr Rajesh K. Gupta, Biologics Quality & Regulatory Consultants, LLC
23rd August 2017
Transformation of Toxicology data into Specific PDE’s
Presented by Kim Li, PhD, DABT, MPH Principal Scientist, EHSS Product Stewardship Toxicology at Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC
23rd April 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
Strategy Emerging Markets for Risk Mitigation
Caustic Stability of Amsphere A3 : Cycling Study with 0.5 M NaOH
Rationale Design of Valves for Flexible Processing
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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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