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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JSR Life Sciences


Featured Articles

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

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

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

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

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Headline News

Perioperative Imfinzi combined with neoadjuvant enfortumab vedotin secures Priority Review status in the US for muscle-invasive bladder cancer patients


Lilly unveils Change the Course Commitment aimed at closing diabetes and obesity treatment gaps in lower-income countries


AstraZeneca commits $2 billion to Summit Therapeutics as part of new equity stake and cancer research alliance centered on antibody drug conjugate combinations


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Upcoming Webinars

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Past Webinars

Considerations on Impact of Raw Material Variability in Gene Therapy Manufacturing: Applying Lessons Learned From Biologics Manufacturing

Presented by Presented by Aaron Mack, Engineer at Biogen and and Greg Stromberg Interim Leader of Global Manufacturing Material Sciences at Biogen,, Dr Lisa Dixon, Acting National Director, Animal Product Import and Export at US DA
22nd October 2020


Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay

Presented by Dr. Ruth Daniels, Janssen & Kevin L. Williams, BIOMÉRIEUX
28th June 2018


Risk Assessment of Extractables and Leachables in Different Phases of Development.

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Ward d’Autry, Study Director E/L & Structural Elucidation, Nelson Labs Europe
22nd April 2021


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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.

There’s no kit for the perfect biotech process. Until now.

 

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Technical Papers

Rationale Design of Valves for Flexible Processing


Strategy Emerging Markets for Risk Mitigation


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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