GonaCon Immunocontraceptive Vaccine

Based upon current responses a future solicitation will be released as a small business set-aside. This announcement does not commit the Government to a solicitation or an award of a contract. A determination by the Government not to open the requirement to competition based upon the response to this notice is solely within the discretion of the Government. At this time (May 2010) the demand for GonaCon is not large enough to justify a manufacturing contract. USDA APHIS will continue to receive information from interested contractors for market research purposes. The conversion of this sources sought notice to a solicitation will be done under this notice (AG-6395-S-10-0042) or, if done under a new notice, a link to the solicitation number will be added to this sources sought notice. By adding this solicitation to your FBO.gov watch list you should get updates of any changes. The United States Department of Agriculture, Animal and Plant Health Inspection Service, Wildlife Services (WS) is seeking interested parties capable of manufacturing GonaCon Immunocontraceptive Vaccine. Manufacturing must be conducted under Good Laboratory Practices, Good Manufacturing Practices or similar ISO certifications. Manufacturing would be required at a minimum of twice per year. The GonaConTM Immunocontraceptive Vaccine formulation consists of a multi-step process where mammalian Gonadotropin Releasing Hormone (GnRH) is conjugated to a mollusk hemocyanin and emulsified in a mineral oil based adjuvant to form the final product (Figure 1). Prior to conjugation the hemocyanin carrier protein must be maleimide activated. Dialysis is performed to remove excess maleimide formed after the activation. GnRH is then conjugated to the maleimide activated hemocyanin. The aduvant is formulated separately from the rest of the vaccine by preparing a suspension of killed bacteria in light mineral oil. Final preparation of the vaccine involves vortex mixing the peptide/hemocyanin conjugate with the adjuvant preparation and producing the final emulsion by running the preparation through an emulsifier. The final emulsion is loaded into 3 ml polyethylene syringes. Individual syringes are then labeled, packaged and shipped to a predetermined USDA facility. All phases of manufacturing must be conducted under clean room conditions. Specialized equipment requirements include a spectrophotometer for quality assurance monitoring, and a emulsification instrument capable of producing 6000 psi (e.g., Microfluidics Model M110L or equivalent).