The new offering– called GMP4Cells – will include the production of master cell banks and working cell banks for products in Phase I and II clinical trials.
The fill finish offering is also intended to support research rather than commercial supply.
CEO Walter Ginsburg said cell banking is a logical addition to Austrianova’s core cell encapsulation business and suggested the new offering is particularly suited to smaller developers.
“These services should allow start-up companies and academic based cell products, vaccines to enter clinical trials in a quality assured manner but at lower cost than other, more conventional, cell banking companies offer.”
The launch of the new services and expansion of the recently established Singapore facility follows a year after Austrianova set up a GMP manufacturing facility in Bangkok, Thailand for its encapsulation service.
Pancreatic cancer cell therapy
The Bangkok facility was set up in collaboration with Austrianova’s partner Nuvilex, a cancer and diabetes-focused clinical-stage biotechnology company that is now known as PharmaCyte Biotech.
In addition to being the regional base for Austrianova’s cell encapsulation business, the facility is also where cells used by PharmaCyte’s developmental pancreatic cancer treatment are prepared and shipped to trial sites.
The treatment is based on ifosfamide, which is a widely-used chemotherapeutic agent that prevents DNA replication in cancerous cells. The drug‘s therapeutic properties are triggered by a liver enzyme called cytochrome P450 that converts the prodrug into its active form.
Ifosfamide has demonstrated significant efficacy against pancreatic cancer. However, the doses required to achieve this are associated with significant side effects.
PharmaCyte’s focus is reducing these side effects by encapsulate combinations of the Ifosfamide prodrug with liver cells that have been modified to a large number of express cytochrome P450 enzymes.