The specific vaccine requested for manufacture is a yeast-based recombinant vaccine targeting the Brachyury transcription factor (GI-6301), in line with the methods detailed by (Heery et al., 2015, Phase I Trial of a Yeast-Based Therapeutic Cancer Vaccine (GI-6301) Targeting the Transcription Factor Brachyury. Cancer Immunology Research, 3, 1248-1256) for experimental purposes.
The yeast-brachyury (GI-6301) recombinant vaccine is composed of heat-killed recombinant S. cerevisiae overexpressing the human brachyury protein. The composition of the vaccine (i.e. antigen), formulation and methodology for production of the vaccine in a yeast expression system is detailed in the patent (please refer to patent no. US0106824A1 (2016) and US9623097B2 (2017)). In summary, yeast cells were transformed with a recombinant nucleic acid molecule encoding the Brachyury antigen under the control of a CUP1 promoter. Antigen expression was induced in yeast cells with CuSO4 in a suitable medium where the pH was maintained at pH 5.5 or higher (6-8 hour culture period). Post-harvest of cultures, yeast cells were heat-inactivated at 56° C for 1 hour. Subsequently, the yeast cells were formulated for injection with a pharmaceutically acceptable excipient. The manufacture of the vaccine is requested for research purposes. The vaccine will not be marketed and distributed to third parties on a commercial basis. The intended use falls into Hatch-Waxman Act in the United States for patented use of drugs for experimental purpose.
Enquiry:
1. Can you manufacture the yeast-based recombinant vaccine?
2. Would it be possible to manufacture under GMP conditions?
3. What would be the purity level achieved during the manufacture process?