We offer comprehensive solution for all your cGMP manufacturing needs. Stelis have fully integrated state-of-the-art facility with end to end capabilities located in Bangalore, India. The facility has the capability to produce simple and complex recombinant biotherapeutics from microbial cell culture system. The facilities have been designed to meet the latest guidelines and expectations of regulators in developed countries (US FDA, EMA) as well as WHO and PICS. We have adopted disposable systems with single-use components and flow paths extensively for better regulatory compliance greater operational flexibility.
|Cartridge||Bausch+Strobel filling line integrated with Steriline isolator||Diameter 7mm to 14mm Height 40mm to 90mm||20 million|
|Pre-Filled Syringe||Bausch+Strobel filling line integrated with Steriline isolator||0.5ml to 10ml||10 million|
|Vial||Tofflon filling line integrated with isolator and Lyophilizer||1ml to 100ml||40 million|
|Lyophilization||Attached to vial filling machine for both clinical and commercial use|| Commercial: 9.2 sq. m
Clinical: 5.11 sq. m
(*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.