10086961Process Development & Cost-Effective Manufacture of Recombinant Hormone for Livestock ReproductionClosedCollaborative R&DInnovate UKReproductive 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.