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Austrianova completes facility for GMP cell banking and fill/finish services for cell therapy products.
Austrianova completed a new facility and is now offering GMP cell-banking and fill-and-finish services for cell therapy products, in addition to its encapsulation services and technology, the company announced in a Jan. 25, 2016 press release.
Austrianova is now able to offer the production of master cell and working cell banks (MCB and WCB) at the size scale required for early (phase I and II) stage clinical trials using its isolator-based production facility. The company can also fill bulk cell product into syringes or vials in its GMP facility. This new cell banking and filling service is called GMP4Cells.
MCB’s and WCB’s are required for all cell therapy products like stem cell therapies and biologics produced from cells such as vaccines, antibodies, and recombinant proteins. Similarly, many companies, including those developing stem cell lines and products, are seeking fill and finish for relative small lots.