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Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.
method transfer, many aspects should be taken into account such as OMCL equipment availability, structural differences of equipment (between manufacturer and OMCL), providing of samples and reagents, only ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mindset of the manufacturer.
structural differences of equipment (between manufacturer and OMCL), shipment of samples and reagents,…. Assay variability and possible changes in analytical methods and specifications during the registration ...