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Issue 5 2016

 

Issue #5 2016 – Digital edition

20 October 2016 | By European Pharmaceutical Review

In this issue: Biosimilars, Informatics, Ingredients, PAT, HPLC, Microbiology, Product Showcase, Regulation, and much more...

Biosimilars: litigation outlook

20 October 2016 | By

In the Foreword article contributed by Consultant David P. Elder in Issue 3, 2016 of European Pharmaceutical Review, entitled ‘Biosimilars: future prospects’, Dr Elder concluded that it is likely that biosimilars will become increasingly established in both Europe and the United States and that in addition to proteins and peptides,…

At-line swabbing analysis as a process analytical tool

20 October 2016 | By Adeyinka Aina and Chris Edlin, Pharmaceutical Manufacturing Technology Centre

Swabbing is a technique commonly used during pharmaceutical cleaning protocols to ensure that the cleaning process meets both safety and regulatory requirements; this allows for the cleaning process to be subsequently verified and validated1-7.