Research & Development Facilities- BioGenomics

Facilities

R&D Facilities

Empowered through research. Enriched through innovation

Indigenous to the core

Completely indegenous technology at each stage of development, including cell lines and process development.
All manufacturing processes established for robustness, using modern ‘Quality by Design’ concepts.

cGMP Production Facility

WHO GMP certified.
Advanced formulation capabilities.
ISO 9001:2015, ISO 14001 and ISO 18001
Aiming to be FDA facility.

Quality that matches only the best

BioGenomics establishes biosimilarity by a thorough characterization proces, using modern technologies which are compliant with global regulatory requirements.
Animal-origin free products.

International standard clinical safety and efficacy trials

EMA and GCP compliant clinical studies.
Statistically significant and meaningful clinical trials.
Clinical trials aimed at establishing biosimilarity, immunogenicity and efficacy using globally sourced reference products

Strong IP portfolio for Value Creation

BioGenomics’ innovations cover supervectors for mammalian and microbial expressions, codon optimised gene sequences, protein folding technologies, novel purification and isolation technologies.

Surface plasmon resonance for receptor binding studies, at R&D Centre, Thane.

Automated DNA sequencing, at R&D Centre, Thane.

LC/MS/MS-Q-TOF, at R&D Centre, Thane.

Gene expression studies, at R&D Centre, Thane

Freeze dryer for active biological substance, at R&D Centre, Thane.

Clones and Cell banks, at R&D Centre, Thane.

Manufacturing

Advanced Biotechnology for Human Health

BioGenomics has a proven expertise in the production of enzymes for the biopharmaceutical industry.Due to its GMP manufacturing, Animal-Origin Free processes and with best-in-class performance, BioGenomics is the preferred provider of these high-quality enzymes to various global biopharmaceutical companies.The portfolio includes recombinant Trypsin, recombinant Cabroxypeptidase B, recombinant Enterokinase and various unique formulations of enzymes.

Automated DNA sequencing, at R&D Centre, Thane.

Fermentation and upstream process at GMP manufacturing plant at Puducherry.

Cell harvesting & homogenisation at GMP manufacturing plant at Puducherry.

Refolding & Protein purification at GMP manufacturing plant at Puducherry.

Combi fill-finish for vials, cartridges & pre-filled syringes at GMP manufacturing plant at Puducherry

cGMP compliant man material flow at manufacturing plant at Puducherry.

Puducherry Manufacturing plant upgrade

Puducherry capacity enhancement underway to meet enhanced market demand

Currently WHO-GMP approved, PICs/EMEA compliant, audit expected post EU filing in 2025

Sanand Facility Ahmedabad

M/s Biogenomics Limited is coming up with a state of art biopharmaceutical manufacturing facility to produce Human Insulin and its analog products, at Sanand GIDC II, Ahmedabad.

The facility shall comprise of Drug Substance manufacturing unit, Drug Product manufacturing unit, with dedicated warehouse and supporting utilities and future expansion space for Admin building, Drug Substance, Drug Product and Warehouse expansion.

The new facility will be designed and implemented for supplying products to India, EU, US and across the global market.

The process operations and equipment shall be designed in accordance with guidelines of WHO, PIC/s, EMA, US FDA and Schedule M.

DS Manufacturing suite at 5000 L Fermenter (Working Volume) scale with Production capacity of 330 Kg DS at Phase 1 and add on 120 KG at Phase 2.

Drug Product Facility shall be equipped with Primary packaging machines, secondary and tertiary packaging machines with capacity of producing 20Million cartridges and 6 Million Vials per annum.