S.E. Asian company, Austrianova, headquartered in Singapore, announced today that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA). This DMF provides all confidential and detailed information covering the production of Cell-in-a-Box® encapsulated cell products based on encapsulated HEK293 cells and derivatives. This includes CypCaps™, the encapsulated cell product that its’ partner and client PharmaCyte Biotech Inc., is about to use in their late stage clinical trial for locally advanced, inoperable pancreatic cancer.
Austrianova’s CEO, Brian Salmons, said “The filing of this comprehensive DMF document is an important milestone event for Austrianova and represents a culmination of many years work on cell encapsulation based on this cell line. The DMF deposited with FDA describes confidential and detailed information about the facilities, processes, and materials used in the manufacturing, processing, packaging, and storing of Cell-in-a-Box® products based on HEK293 cells. The information contained in the DMF will be used to support PharmaCyte’s Investigational New Drug Application (IND) on CypCaps™ for the upcoming clinical trial for the treatment of pancreatic cancer.”
A DMF is a document that is submitted to a regulatory agency and contains complete information on an Active Pharmaceutical Ingredient and/or finished Drug Product. It comprises factual and complete information on a Drug Product’s raw materials, process development and manufacture, analytical methods, stability, purity, packaging and its cGMP status. The DMF filing allows a company to protect its’ intellectual property from partners while complying with regulatory requirements for disclosure of processing details.
Austrianova, (www.austrianova.com) part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated human or animal cells from rejection by the immune system and allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop a wide range of standard cells as one-for-all living pharmaceuticals. Bac-in-a-Box® is a similar protective device adapted for encapsulation of bacteria and yeast, including probiotics, and has both human food as well as animal feed applications due to its ability to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid. Austrianova now also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as “Fill and Finish” services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, antibodies, recombinant proteins etc).