Technology Transfer and Manufacture of Recombinant Protective Antigen (rPA), Intranasal Vaccine.

Descriptions

Porton Biopharma Limited (PBL) requires the GMP manufacture and release of approximately 5 000 Aptar Bidose nasal sprayer devices containing PBL's adjuvanted recombinant vaccine. The GMP manufactured vaccine will be assessed in a Phase 1 Clinical Trial, within the USA.In order to satisfy this requirement, the ‘Offeror’ will be required to transfer the established PBL vaccine mixing process (recombinant antigen and oil/water adjuvant emulsion) and demonstrate a successful technology transfer according to agreed pre-determined criteria.Following a successful technology transfer, the ‘Offeror’ will manufacture and release Engineering batches at various recombinant antigen strengths, according to agreed pre-determined criteria. PBL will perform stability studies on the Engineering batches for 6 months and provided satisfactory stability data is achieved, PBL will then require the manufacture and release of GMP batches at various recombinant antigen strengths, according to agreed pre-determined release criteria. The ‘Offeror’ will be expected to perform stability studies on the GMP batches.Some of the established analytical methods for in-process testing, characterisation testing and release testing will be technology transferred from PBL to the successful ‘Contractor’. In addition, the ‘Offeror’ will develop and as appropriate qualify spray characterisation release tests, as described in the FDA Guidance for Industry (2002), for nasal sprays. PBL will perform a sub-set of the analytical methods for the Engineering and GMP batches.PBL will supply the recombinant antigen and the adjuvant emulsion, as well as Reference Standards and methodologies for analytical testing.Although there is no current requirement for sterile manufacture, it is expected that the ‘Offeror’ will have the capability to perform the filling process in a Class 100 (Grade A) environment, to limit endotoxin and bioburden contamination.A Manufacturer's Authorisation for Investigational Medicinal Products (MHRA) or FDA equivalent and a Certificate of GMP compliance from the relevant regulatory body are mandatory requirements for responding to this advertisement.Experience of manufacturing and automated filling of a pharmaceutical product into an Aptar Unit Dose or Aptar Bidose and suitable labelling for a Phase 1 Clinical Trial in the USA, are mandatory requirements for responding to this advertisement.