Syngene International Limited is the largest Contract Research Organization of India offering a suite of integrated, end-to-end discovery and development services for novel molecular entities across small and large molecules, antibody-drug conjugates and oligonucleotides. Our nearly 300 global clientele covers diverse sectors including pharmaceutical, biotechnology, agrochemicals, consumer health, animal health, cosmetic and nutrition companies. The Company’s integrated discovery and development platforms help organisations conduct discovery (from hit to candidate selection), development (including pre-clinical and clinical studies, analytical and bio-analytical evaluation, formulation development and stability studies) and pilot manufacturing (scale-up, pre-clinical and clinical supplies) with a distinctive economic advantage.
Our broad capabilities in Biologics include:
- Bio-therapeutic discovery & cell line development
- Development & manufacturing of proteins ranging from <5 kDa to 10,000 kDa
- Tox, Clinical and Commercial Drug Substance (DS) supplies
- Product/process development & characterization including bio-similarity assessment
- Disposables based (2000L X 3 trains) manufacturing facility
- Antibody expression ~4 g/L and E. coli expression ~5 g/L
- Viral testing services (first ever in India), Immunogenicity assays and Antibody drug conjugates under one roof
- Gene to clinic in 16 months
We have supplied 8 novel Biologics in 5 years for clinical trials to US, EU, Australia, Singapore & India. Our new Biologics Manufacturing facility has three single use bioreactors each having a capacity of 2,000L. It will also have two upstream suites that will enable parallel operations, and one downstream train with post-viral segregation.