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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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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Headline News

Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


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Upcoming Webinars

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Past Webinars

Demonstrate how machine learning tools can aid development of formulation, analysis and manufacturing of pharmaceutical drug products

Presented by Erik Skibsted, Principal Scientist PhD, Novo Nordisk Denmark and Rolf Taaning, Development Specialist PhD, Novo Nordisk Denmark
08th March 2021


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


Impact of Depth Filtration on Disulfide Bond Reduction during Downstream Processing of Monoclonal Antibodies from CHO Cell Cultures

Presented by Brian O' Mara, Senior Research Scientist I at Bristol-Myers Squibb and Alexei Voloshin, Global Application Strategy Specialist at 3M Separation and Purification Sciences Division
08th October 2018


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