Propanc Biopharma (OTCQB:PPCHD) provided an update on the development of the GMP-compliant investigational medicinal product (IMP) manufacture of PRP for first-in-human studies.
As quoted in the press release:
PRP is a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen.
Both proenzymes have been successfully isolated from natural sources to a defined quality and will be purified further to GMP standards to obtain the final IMP. The isolation processes for both proenzymes have been established and scaled up to commercial size quantities. These freeze dried isolates will serve as starting materials for the Good Manufacturing Practice (GMP) manufacturing processes, which are currently under development for both proenzymes by the Company’s manufacturing partner, Q Biologicals, in Ghent, Belgium.
In order to define the optimal purification process, the starting materials were characterized for identity and impurities in the laboratories of Professor Buchner, Chair of Biotechnology, from the Technical University of Munich. Furthermore, analytical methods to initially determine and then control the quality of the starting materials are nearly fully established and specifications defined to ensure a consistent quality of IMP.