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Issue 3 2022

 

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Guide to Data Integrity

28 June 2022 | By

Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Anca Ciobanu, Strategic Theme Lead at the Pistoia Alliance, discusses the need for data integrity in life sciences and how costs can be reduced but patient safety increased, and Charles River showcase their services and how they stand…

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Rapid method development to overcome challenges of bi-specific antibody purification

27 June 2022 | By ,

The landscape of biopharmaceutical manufacturing is changing, with complex molecules such as bi-specific antibodies (bsAbs) becoming increasingly prevalent. bsAbs are a large, structurally diverse family of molecules designed to recognise two targets and globally there are over 230 in development as promising therapies for cancer and other diseases. While they…

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Efficient shutdown recovery: leveraging RMM to unlock value and ensure environmental quality

24 June 2022 | By , ,

New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…

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Testing non-inferiority for accuracy of quantitative microbiological methods

21 June 2022 | By , , ,

Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.