Integrated state-of-the-art manufacturing facility leverages microbial and mammalian platforms for the development and commercial manufacturing of biologics and biosimilars in multiple fill-finish formats.
As a CDMO partner for the global biopharmaceutical industry, Stelis is committed in helping you achieve your project goals and timelines by accelerating the development and commercialization of biologics, mutually benefiting in the growth trajectory. Our highly automated cGMP compliant facilities offer process development through clinical and commercial manufacturing, at various flexible scales to fit the individual client and product requirements.
With deep technical expertise and capabilities coupled with marquee partnerships, Stelis has developed biologics for diabetes, osteoporosis and haemorrhoids using mammalian and/or microbial systems from the pre-clinical stage through commercialization. We remain a preferred choice for our clients because we offer customized services according to their requirements in size, scale, design, and business model.
Manufacturing Capacity
Drug Substance
Microbial Facility
- 1 X 1000L stainless steel fermenter
- Homogenizer (GEA) and centrifuge (GEA) integrated with fermenters
- Capable of handling bacterial and yeast strains
- Flameproof area with a high-pressure chromatography system
- Filtration: viral filtration, ultrafiltration and diafiltration
- Dedicated area for conjugation, bulk filtration & lyophilization
Mammalian Facility
- 4 X 2000L bioreactors
- Single-use bags-based drug substance manufacture
- Dedicated pre-culture suites, media & buffer preparation rooms
- Controlled freeze and thaw system
- Production, testing and storage of master and working cell banks
- Filtration: viral filtration, ultrafiltration and diafiltration
Drug Product
- Drug product capacity- 40 million cartridges, 28 million pre-filled syringes, 70 million vials (liquid and lyophilized)
- Tofflon filling line integrated with isolator and lyophilizer
- High-speed vial lines attached to vial filling machine
- Bausch Strobel filling line integrated with steriline isolator
- 2 Boilers of the capacity of 3000 kg/hr and one of 5000kg/hr
- Cooling tower with a capacity of 180 TR and 4 HVAC chillers of capacity 180 TR
- Secondary packaging operations at a capacity of 100 cartons/ min
- High-capacity warehouse with cold chain inventory management
Quality Control
- On-site analytical and microbiology labs to support in-process and release testing
- Comprehensive monitoring of all in-process product quality parameters, drug substance and drug product release testing
- Usage of a fully automatic packaging line and 100% visual inspection of the entire process
- Routine facility contamination controls by utilities testing and environmental monitoring activities by active air sampling, passive monitoring by settle plate and surface monitoring for classified areas and inbuilt active air samplers within isolators in line with regulatory requirements. Environment isolates and organisms recovered from investigational samples are identified up to species level
