Manufacturing Report for Recombinant S-Antigen (rS-Ag)

Abstract

The National Eye Institute generated a recombinant construct using human S-Ag for use in clinical trials for the treatment of uveitis, an inflammatory reaction of the eye. This recombinant construct was used to first produce cell banks that ere further used to seed an 80L fermentor for the production of rS-Ag. rS-Ag was expressed as insoluble inclusion bodies in the fermentation media. The inclusion bodies were isolated and the protein of interest was refolded into its correct confirmation. The refolded protein solution was put through various chromatography methods to purify the protein of interest. The purified bulk biological substance was stored at ≤-80°C for further manufacturing. This Master Field Project involved the accumulation and incorporation of the appropriate manufacturing information for producing rS-Ag as a biological substance into a Manufacturing Report. This Manufacturing Report contains information regarding the generation of the recombinant construct, cell bank production and testing, fermentation, purification, and final testing of the bulk product. This Manufacturing Report can be further developed to include all of the appropriate and required information for a Chemistry, Manufacturing, and Controls section of an Investigational New Drug Application. A number of regulatory regulations and guidance documents have been referenced as vital sources for the content and format.