Biotechnology firm ProGen Pharmaceuticals has spun-out its manufacturing operations as the new wholly-owned subsidiary PharmaSynth.
The new entity's initial focus will be furthering the development of ProGen's candidate anticancer agent PI-88, which is currently in Phase II trials for both post-resection liver cancer and melanoma. The firm's first task will be the production of sufficient quantities of the drug for late-stage clinical trials which are expected to begin in the next 12 to 18 months.
PharmaSynth will also offer a range of biologic and small-molecule drug contract manufacturing and development services to the pharmaceutical and biotechnology industries. The firm's core competencies and technologies cover angiogenesis, epigenetics and cell proliferation.
Justus Homburg, Progen's CEO, said, "The spin-out of the manufacturing operations is consistent with Progen's core drug development focus. The manufacturing operations have served us very well to date but with the decision having been made to outsource the commercial supply of PI-88, the time is right to let the manufacturing business develop and grow in its own right."
Echoing these thoughts PharmaSynth's CEO, Leslie Tillack, said: "This is an exciting development for the Australian biotech community as PharmaSynth will be able to provide a viable alternative to overseas manufacture of early phase pharmaceuticals and veterinary drugs."
Broad range of services
Brisbane, Australia-headquartered PharmaSynth will operate from a 2,000 metre square modular manufacturing that can provide up to 2,000 litres of fermentation capacity.
The site also incorporates a series of modular clean room laboratories with grade D fermentation suites, purification and final product isolation rooms that are ISO 7 compliant. In addition, the facility's laboratory area is supported by a range of raw material, in process and finished product storage areas ranging from 80°C to controlled-ambient.
The facility holds good manufacturing practice (cGMP) accreditation issued by both the Australian Therapeutic Goods Administration (TGA) and the Australian Pesticides and Veterinary Medicines Authority (PVMA). It is also licensed by the country's Office of the Gene Technology Regulator (OGTR) to make drug products using genetically modified organisms.
PharmaSynth will also offer manufacturers both cell bank preparation and validation services, as well as fermentation optimization and purification capacity.