Syngene can handle integrated development of large molecule candidates including antibodies, recombinant proteins and protein-based vaccines from an identified candidate to IND submission. This includes cell line generation, cell banking and characterization, process, analytical and formulation development, scale up, and manufacturing of tox lots and clinical lots – Drug Substance and Drug Product. Process development till supply of tox lots is the key rate-limiting step in early stage development and hence, timeline is a critical factor at this stage.
Syngene has well equipped development labs, and the technical and regulatory understanding to provide rapid, phase-appropriate development and data package for IND submission. Our cGMP manufacturing facilities are compliant with USFDA and EMA guidelines, and we have experience in scaling up from the laboratory scale to the pilot production scale with minimal experimentation. Our regulatory department can also prepare or assist in the preparation of IND submission package. Rodent toxicity studies can be handled at the state-of-the-art Syngene vivarium, while larger-animal studies are conducted through partnerships where Syngene can manage the third-party contract in terms of protocol design, study monitoring and project management, in consultation with the client.