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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

A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor

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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA

Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

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Headline News

FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications

Alexion strengthens research leadership in gMG care with new data at 2026 AANEM Annual Meeting and MGFA Scientific Session

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

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

Commercial Cell Therapy Experience Using Mycoplasma NAT For Product Release: Five-Year Review

Presented by John Duguid, Executive Director, Research & Development at Vericel Corporation and Lori Daane, Pharma Microbiology Sr. Scientific Director at bioMérieux and Mike Brewer, Director, Global Principal Consultant, Regulatory, BioProduction at Thermo Fisher Scientific
01st November 2022

ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics.

Presented by Jason Creasey, Managing Director at Maven E&L Ltd, Piet Christiaens, PhD, Scientific Director and Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director at Nelson Labs
14th September 2022

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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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