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

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

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Monica Cardona and Ian Johnson Pall Life Sciences

Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma

Changing Column Packing from an Art into a Science

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Headline News

FDA review of Novo Nordisk’s denecimig for haemophilia A runs longer as manufacturing facility remediation continues


AstraZeneca opens $1 billion global research centre in Cambridge Massachusetts that will lift its local workforce by more than 50 per cent


FDA clears Jaypirca as first line treatment for certain previously untreated CLL and SLL patients


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Upcoming Webinars

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Past Webinars

Biopharmaceutical process development – Trends/ Challenges/Opportunities

Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and  Validation Consulting group at Pall Biotech
20th November 2019


Real Time Monitoring of Bioprocess and Beyond – A Process Analytical Perspective

Presented by Dhanuka Wasalathanthri, Senior Scientist at Bristol Myers Squibb and Julia Ding, Head, Global Process Analytical Development at Bristol Myers Squibb and Eric Carlson, Ph.D., President & CEO, Protein Metrics Inc.
16th November 2020


Modernizing Biopharmaceutical Manufacturing: from Batch to Continuous Production

Presented by Robert Dream, PE, CPIP, of HDR Company, LLC
19th July 2017


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