Analytical laboratory services for characterisation of novel recombinant protein called DST-F.

Tender description

The authority is seeking to appoint a contractor to carry out analytical characterisation of the novel recombinant protein called DST-F ( DIVA skin test protein-fusion) to support APHAs application for UK veterinary Market Authorisation (MA) from the Veterinary Medicines Directorate (VMD). Lot 1: Analytical laboratory services are required to carry out analytical characterisation of the novel recombinant protein called DST-F ( DIVA skin test protein-fusion) to support APHAs application for UK veterinary Market Authorisation (MA) from the Veterinary Medicines Directorate (VMD). APHA require physiochemical properties and structural characterisation analysis to support evidence of the DST-F’s product. Investigating pattern of heterogeneity and consistency of the product as would be expected for an IVMP (Immunological Veterinary Medicinal Product) by the regulator VMD. It is thus of great importance to source a contractor that has the expertise to perform a series of validated tests on the DTS-F recombinant protein to establish the analytical characteristics. The analytical procedures shall be validated in accordance with VICH ( International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products)/ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and EU guidelines. Additional information: The purpose of this PIN is to alert the market to a possible opportunity.