The invention provides optimized processes for the production and purification of
recombinant glycoprotein hormones, including recombinant
human chorionic gonadotropin (r-hCG), recombinant human
luteinizing hormone (r-hLH), recombinant
follicle-stimulating
hormone with extended half-life (FSH-CTP), and recombinant human
follicle-stimulating
hormone (r-hFSH). The processes employ sequential
chromatography and
filtration steps— affinity, hydrophobic interaction,
ion exchange, mixed-mode, ultraf iltration / diaf iltration,
nanofiltration, and final sterilizing
filtration— with precisely controlled pH,
conductivity, and buffer conditions. These strategies ensure robust viral clearance, high
recovery yields, and effective removal of host
cell proteins,
DNA, aggregates, and other impurities, resulting in highly pure and stable
drug substances. Analytical data from multiple batches confirm identity, consistency, and clinical suitability. The invention thus establishes a unified and scalable platform for large-scale manufacture of
recombinant glycoprotein hormones for therapeutic use in
fertility and reproductive healthcare.