We offer comprehensive solution for all your cGMP manufacturing needs. Stelis’ fully integrated, end-to-end facility in Bangalore is expected to come on stream by end of 2018. The facility has the capability to produce simple and complex recombinant biotherapeutics from both microbial & mammalian cell culture systems. The facilities have been designed to meet the latest guidelines and expectations of regulators in developed countries (US FDA, EMA) as well as WHO, PICS. We have adopted disposable systems with single-use components and flow paths extensively for better regulatory compliance & greater operational flexibility.
|Presentation||Equipment||Working Range||Production Capacity / Annum*||Starting by|
|Cartridge Filling||Bausch+Strobel filling line integrated with Steriline isolator||Diameter 7mm to 14mm Height 40mm to 90mm||20 million||Q4-2018|
|Pre-Filled Syringe Filling||Bausch+Strobel filling line integrated with Steriline isolator||0.5ml to 10ml||10 million||Q4-2018|
|Vial||Tofflon filling line integrated with isolator and Lyophilizer||1ml to 100ml||10 million||H2 - 2019|
|Lyophilization||Attached to vial filling machine for both clinical and commercial use||Commercial: 9.2 sq. m
Clinical: 5.11 sq. m
|2 million||H2 - 2019|
(*on single shift basis)
We offer on-site cGMP analytical & microbiological testing services to support in-process and release requirements. We also offer thorough characterization of reference as well finished product for complete analytical comparability requirements.