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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

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

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 processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

Coupling single-pass TFF before loading onto a chromatography sorbent

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Headline News

FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting

RYBREVANT FASPRO combination shows 77% response rate in first-line advanced head and neck cancer

FDA approves subcutaneous SKYRIZI induction regimen for Crohn’s disease

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Upcoming Webinars

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Past Webinars

Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab

Presented by Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSAT
25th January 2019

Novel Technologies That Aid the Detection and Differentiation of Proteinaceous Impurities in Biologic Drug Substances and Drug Product

Presented by Danny Chou, President and Founder at Compassion BioSolution, LLC
30th November 2020

Enabling comprehensive data analytics and process monitoring in Biomanufacturing – Key success factors, methodologies and practical insights that lead to a successful implementation

Presented by Robert Dimitri, Hugo Guerra and Gloria Gadea-Lopez, Ph. D
17th January 2018

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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.

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

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Technical Papers

Amsphere TM A3

Lifetime study for JSR Amsphere A3 – protein A resin

Strategy Emerging Markets for Risk Mitigation

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