Syngene offers cGMP manufacturing services for both microbial and mammalian cell-based processes. We specialize in the production of therapeutic biologics such as recombinant proteins and monoclonal antibodies for pre-clinical, clinical and commercial supply.
We have catered to multiple clients globally for their manufacturing requirements of material for pre-clinical and late phase clinical as well as commercial manufacturing. Multiple fermentation processes that include batch, fed-batch, and perfusion technologies are available. The team is experienced in transferring-in processes with minimal engineering and scale-up runs. Our facilities are independent state-of-the-art cGMP production units with combination of single use and reusable process equipment, for microbial fermentation and mammalian cell culture derived products.
Our capabilities include Clinical and Commercial scale production. We have extensive experience in novels and Bio-similar mAbs. We have well-established Quality Management System and Document Management System with Electronic Records and Electronic Signature (ERES)compliant equipment. Our facility is equipped to handle remote audits.
Our Biologic Manufacturing facility can cater to multiproduct production campaigns simultaneously based on single use technology platform. It is designed for supporting our clients for long term commercial manufacturing campaigns. We have a wide range of sophisticated and high-end equipment and rich experience on handling cell culture-based products.
Upstream Process Suites
Scale Details Of Dedicated Manufacturing Facility
Upstream: Two suites (from Inoculum to Production reactors), 3 x 2KL
Downstream Process Suites
Scale Details Of Dedicated Manufacturing Facility
Harvest:
Continuous centrifuge (up to 2000 LPH flow rate) and/or Depth Filtration (up to 44 sqm area)
Downstream:
- Pre-viral (two rooms – with all chromatography steps, UFDF, Viral filtration)
- Post viral (one room –UFDF and final filtration – closed operation),
- Can handle products with 4 chromatography steps – Flow rate up to 2000LPH
- Column size > 800mm (depends process and operating conditions), currently till 600mm
Biologics (Microbial) Manufacturing Plant
cGMP Microbial (facility to be operational by Q4 2020 )
Major Equipments
- 200L (SS) and 500L (SS) fermenters
- Continuous centrifuge
- Cell homogenizer
- Chromatogaphy systems
- TFF systems
Capabilities
- Recombinant proteins from bacteria and yeast with intracellular or secreted expression
- Live biotherapeutic products (LBP)
Scale
- Up to 500L (SS) fermentation, 1000L refolding, 60-cm column chromatography and 10-sq.m. tangential flow filtration
