Having completed the set up of its new GMP facility in Singapore, Austrianova is now offering clients a GMP cell banking—master cell bank (MCB) and working cell bank (WCB)—as well as a fill and finish service for cell therapy products, in addition to its encapsulation services and technology. Austrianova offers the production of MCB and WCB at the size scale required for early phase 1 and 2 stage clinical trials using its state-of-the-art 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. MCBs and WCBs are required for all cell therapy products such as stem cell therapies as well as biologics produced from cells such as vaccines, antibodies and recombinant proteins. Similarly, the company says many companies, including those developing stem cell lines and products, are seeking high quality economic fill and finish for relative small lots.

“We see this as a natural add-on to our already established Cell-in-a-Box cell encapsulation technology for which we have recently set up a GMP manufacturing facility in Thailand,” said Walter Gunzburg, chairman and chief technology officer, Austrianova. “This kind of MCB and WCB production as well as fill and finish services for cells are, however, stand alone services. Although these services are generally available to all customers, they should allow start up companies and academic-based cell products and vaccines to enter clinical trials in a quality assured manner but at lower cost that other, more conventional, cell banking companies offer.”

“In addition to our state-of-the-art facility, Austrianova offers services that comply with major international regulatory agencies using a customized German/Swiss-based quality assurance system,” said Brian Salmons, chief executive officer, Austrianova. “Our team has many years experience with regulatory agencies around the world and has taken cell therapies into clinical trials.”