Public Funding for Genesis Manufacturing LTD.

Reproductive success in livestock is essential for the economic livelihood of producers and ultimately affects the consumer cost of meat and other animal products. In many livestock production systems, poor fertility is a major factor that limits productivity. Assisted reproduction, such as in vitro fertilisation (IVF), underscore sustainable livestock production strategies. Follicle Stimulating Hormone (FSH) is vital to fertility. Without FSH, follicles will not be stimulated to produce eggs and won't ovulate. Currently, all FSH products on the market for livestock reproduction use ovine or porcine pituitary gland tissue as the raw starting material. Our product, Ovagen, and competitors' products have experienced manufacturing delays for the last two years due to raw material unavailability. Follicle Stimulating Hormone is a heterodimer consisting of non-covalently bound alpha and beta subunits that requires complex glycosylation post-translational modifications for biological activity that is only achievable in mammalian cells. Mammalian cell expression of recombinant FSH in CHO cells is currently on the market for human applications; however, the dose required for animals is much larger and mammalian cell expression systems are simply too expensive for the agriculture industry. Our project is focused on the process development of recombinant FSH using a cost-effective non-mammalian expression platform and manufacturing process that is affordable for livestock reproduction.

Cell therapies offer the opportunity to treat and cure serious unmet medical needs. BioDivide has discovered an innovative manufacturing technology to develop VESCO-R® - a suspension of autologous Mesenchymal Stem Cells (MSCs) derived from a limited peripheral blood sample. Current state-of-the-art processes to isolate MSCs from peripheral blood are highly inefficient and variable. The Company screened >500 conditions to develop the underpinning science for this break-through technology. Current autologous stem cell biopsy techniques require invasive surgical procedures (e.g. bone marrow and adipose tissue harvesting under general anaesthetic). Peripheral blood donation is minimally invasive and would overcome significant barriers to the industry. BioDivide, in collaboration with Genesis, is seeking Innovate UK Funding to enable the translation of this technology from the bench to a market-ready manufacturing process and the therapeutic product, VESCO- R®. BioDivide envisions transforming regenerative medicine by initially validating VESCO-R® for musculoskeletal disorders in veterinary medicine with the ultimate aim to translate this technology to human health.blic Project Summary