Current Issue

From Aberrant Results to Alternative Methods: Strengthening Pharmaceutical Laboratory Deci...

Dr Markus Funk, Operations Director Analytics Axel. H. Schroeder, Operations Director Micr...

Sterility Assurance – An Enabler to Comply with Annex 1

Robert Dream, Managing Director, HDR Company LLC

Harmonization of Viral Segregation Strategy for a Manufacturing Network with Multiple Faci...

Bonnie K. Shum, Senior Director, Product Technical Leader, Genentech

Raw Material Qualification – A Practical Approach

Aurora Henry, GMP Quality/ Raw Material Quality/Material Control Leader

Caustic Stability of Amsphere A3 : Cycling Study with 0.5 M NaOH

JSR Life Sciences


Featured Articles

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

Changing Column Packing from an Art into a Science

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

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

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Headline News

Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study


CAPLYTA shows rapid improvement in bipolar mania in second pivotal Phase III study


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Upcoming Webinars

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Past Webinars

Think Big, Start Small – Capability Implementation on the Path to Smart Manufacturing within Industry 4.0

Presented by Robert Guenard, Senior Director - Manufacturing Sciences at Biogen, Petter Moree, Global Industry Principal at OSIsoft and Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech
13th November 2020


Points to consider when defining a microbial control strategy for individualized ATMPs

Presented by Friedrich von Wintzingerode, PhD, QC Lead iNeST Project (individualized Neoantigen Specific Therapy)
05th April 2023


Mass Transport Modelling in support of leachable risk management

Presented by Thomas Egert, Research Scientist Pharmaceutical Contact Materials at Boehringer Ingelheim Pharma GmbH and and Jason Creasey, Managing Director at Maven E&L Ltd
17th January 2023


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