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Issue 5 2016

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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...

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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,…

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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.