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Issue 3 2022

 

article

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…

article

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…

article

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.