INOVIQ Limited (ASX:IIQ) has executed a Master Manufacturing Agreement with MP Biomedicals, a global supplier of life science and diagnostic products, for the contract manufacture of INOVIQ’s proprietary SubB2M protein.
SubB2M technology and pipeline
The SubB2M protein is a key reagent used in INOVIQ’s SubB2M-based tests for the monitoring and detection of cancer.
SubB2M specifically detects the pan-cancer biomarker Neu5Gc that is found in multiple human cancers, including breast, ovarian, prostate and others. INOVIQ holds the exclusive worldwide licence from the University of Adelaide to the SubB2M technology for use in diagnostic applications.
INOVIQ’s SubB2M diagnostics pipeline includes SubB2M-based immunoassays for monitoring breast and ovarian cancers, and a SubB2M-based surface plasmon resonance (SPR) test for the detection of Neu5Gc levels in a general health panel.
The company recently signed a Master Services Agreement with US-based contract diagnostics organisation ResearchDx to further the development and validation of its SubB2M-based tests in the USA. This manufacturing agreement enables production of high-quality cGMP grade SubB2M protein required by ResearchDx to complete commercial development of the SubB2M tests.
Master Manufacturing Agreement with MP Biomedicals
The Master Manufacturing Agreement with MP Biomedicals Asia Pacific Pte Ltd is for the provision of contract manufacturing services to produce the SubB2M protein to cGMP standard. Manufacturing will take place in MP Biomedicals’ Singapore facility.
The agreement follows the successful technology transfer of the SubB2M manufacturing and quality control processes from the University of Adelaide to MP Biomedicals for the routine production and testing of the protein (required prior to release) for commercial applications.
The manufacture of the SubB2M protein at MP Biomedicals’ cGMP and ISO 13485 certified Singapore facility will be an important milestone for INOVIQ as it will ensure:
- Manufacture of the SubB2M protein in a cGMP (current Good Manufacturing Practice) environment, under an ISO 13485 accredited quality assurance program
- Streamlined production process for cost effective manufacture and release of SubB2M protein
- Material that may be used in a range of applications, including for research, clinical development, and in vitro diagnostic commercial applications
- A scalable production process enabling continuity of supply of the SubB2M protein for INOVIQ’s in-development SubB2M-based diagnostic tests.
Securing commercial supply of the SubB2M protein is a key milestone for INOVIQ. MP Biomedicals is a highly respected global supplier of life science and diagnostic products and we are therefore delighted to partner with them to ensure the commercial supply of SubB2M protein, which are critical components of our SubB2M-based tests for breast and ovarian cancer,” INOVIQ CEO Dr Leearne Hinch said.
“INOVIQ would like to acknowledge funding support for its SubB2M program from the Biomedical Translation Bridge (BTB) program, which is delivered by MTPConnect and is part of the Australian Government’s Medical Research Future Fund.”
