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The increase in licensed mAb products available to the NHS has had significant positive benefits to patient outcome, but has added to the challenges for pharmacy services. Availability of stability data on compounded mAb is limited and the complex structure and action of mAb’s requires a range of physicochemical tests and an appropriate functionality/activity test to demonstrate stability and on-going activity are retained. QCNW-Liverpool has over 12 years’ experience in planning, performing and managing stability studies on mAb preparations. Studies have been carried out for NHS and commercial Pharma in the UK and worldwide.
Studies have been performed on; Bevacizumab, Trastuzumab (Herceptin and Biosimilar), Rituximab, Infliximab (Remicade and biosimilar), Ranibizumab, Pembrolizumab and Nivolumab.
Techniques used for mAb studies within QCNW-Liverpool include: pH, sub-visible particle counts, SEC-HPLC, reduced and non-reduced capillary gel electrophoresis, capillary zone electrophoresis and ELISA. When under taking mAb studies, the laboratory works closely with a specialist partner to deliver cell assay analysis.