FDC is aggressively working in the field of Biotechnology, having it’s core competency in bacterial fermentation, purification and formulation of recombinant proteins.
The Biotechnology section has a well-equipped bioanalytical research laboratory for protein analysis, molecular biology, cell culture, and microbiology; and a process development laboratory for upstream and downstream processes. The section further has a specialized R & D microbial evaluation laboratory, dedicated exclusively for microbiological evaluation of New Chemical Entities, especially on antifungal activity, wherein in-vitro screening of NCEs is performed as per the standard guidelines, and NCEs are recommended for in-vivo efficacy and toxicity studies
With it’s research capability in Biotechnology, FDC has successfully produced, purified and formulated a recombinant protein, on a commercial scale. Preclinical toxicity trials of the recombinant product, as per DBT / RCGM approved protocol, have been successfully completed, and are to be followed by human clinical trials.
The biotechnology department has successfully converted three API molecules from non-sterile to sterile APIs, using novel methods and aseptic techniques. Further, the department has acquired an Indian patent IN251861 for the invention titled “Method for Determining the Potency of G-CSF”.