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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

James Barry, Director of Marketing, Americas, Pall Biotech

Volume Reduction and Process Optimization with Cadence Inline Concentrator

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


Spruce separates CRHX-101 programme into new endocrinology company Adrenyx Biosciences


FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


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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


ICH Q3E Guidelines and Its Implications

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Dries Cardoen, Team Leader of Study Directors Inhalation/topical/transdermal products at Nelson Laboratories, LLC
22nd 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


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