AboutUs Profile

Giving life to process and product innovation by leveraging protein analysis at a commercial scale to innovate tomorrow's healthcare.

The evolution of biotechnology from the 1980s has propelled healthcare into exploring new dimensions of working with large molecule drugs which have led to the incorporation of innovative processes for Recombinant Therapeutics.

The Biotechnology team at FDC has built a strong competency in bacterial fermentation, purification and formulation of recombinant proteins.

Similar to the Formulation development and Organic Synthesis departments, the Biotechnology department is also powered by world-class laboratories that are backed by complementary labs like bioanalytical research laboratory for protein analysis, process development laboratory for upstream and downstream processes. We also possess a specialized Microbial evaluation laboratory solely developed for the microbiological evaluation of new chemical entities. Acute oral toxicity studies was conducted for three shortlisted NCE's and found to be non-toxic & classified as Category 5. These molecules have been further taken for formulation development activity.

FDC holds an Indian Patent for determining the potency of G-CSF. (IN251861)
We have been successful in the production, purification and formulation of recombinant protein on a commercial scale. Preclinical toxicity trials of one of the recombinant product, as per DBT / RCGM approved protocol have been successfully completed and we have received a go ahead for conducting clinical trial batches. FDC has received an NOC from CDSCO/FDA to conduct clinical trial batches at their Bioprocess facility at Jogeshwari.