Process Validation

ABL Europe

ABL Europe has experience supporting clients with GMP supply of viral vectors for use in phase 3 pivotal efficacy trials. Regulatory authorities worldwide require sponsors to expand their CMC section content, as a part of their product licensure applications, for e.g. Marketing Authorization Application (MAA), Biologics License Application (BLA).

How can we help you?

Managed by ABL Europe’s validation department, the team has experience performing small scale process qualification and characterisation studies, GMP process performance qualification lots / validation batches, and analytical methods validation; all captured under respective validation protocols and reports, defined from the validation master plan. In collaboration with the client, ABL will perform a GAP analysis and quality risk assessment, to identify and document the process inputs (material attributes, process parameters) that are able to influence the quality attributes and process parameters, implementing a process design and control strategy as part of a product lifecycle approach.

ABL Europe is actively preparing for preapproval inspection in 2021 and is expanding capacity availability to meet the increased demand. At the current time, approved / licensed products are not yet manufactured by ABL.