Gennova’s Process Development Laboratory (PDL) fills in the huge gap in the availability of resources (instruments, equipment and manpower) through its Product Development Program (PDP) using diverse production platform (Microbial/Mammalian) that can develop the processes right from cell banking to cGMP pilot manufacturing, validating all methods (in-process, analytical etc.) and processes making it suitable for required technology transfer for manufacturing of clinical studies.
Under the National Biopharmaceutical Mission, an initiative of Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology, Ministry of Science and Technology, Govt. of India, Gennova is creating a shared PDL facility to enable ease of bench to bed side transition from taking a product at the proof-of-concept stage to Phase III CT material production and assist in preparing regulatory documentations for submission.
Gennova would like to collaborate with interested academics, institutions and small start-ups and welcomes all who are likely to benefit from this symbiotic association.
To participate in the Product Development Program (PDP) at Gennova’s PDL, please contact Ankita.Bhargava@gennova.co.in with the following information:
a. Name
b. Your organization
c. Brief description of your project
d. Service that you seek
With a state of the art Research and Development (R & D) facility — ‘Gennova Vaccine Formulation Centre and Research Laboratory’ which is recognized by Department of Scientific and Industrial Research (DSIR) with lab space of over 44,000 sq. ft.
The R & D facility was established with the following primary objectives:
- Recombinant cell line development for protein therapeutics and antigens as vaccine candidates;
- Process development for protein therapeutics and antigens as vaccine candidates;
- Product characterization and analytical method development; Formulation development.
The current PDL unit has molecular biology, upstream process development, downstream process development, analytical development and formulation development laboratories for making research and clinical grade for phase-1 biologics for therapeutic and vaccine purpose. Gennova have proven expertise in three expression platforms which includes mammalian cells, yeast cells and microbial expression technology. Gennova has the capability of designing and execution of processes from gene to finish products. Our formulation facility can produce GMP grade material for clinical trials up to phase-1. Gennova as a company focuses on optimizing processes that will eventually result in healthcare transformation.