Drug Product Capacities
We solve the problems of today to create the products of tomorrow.
Drug Product manufacturing facility of Stelis is equipped for formulation development for liquid and lyophilized drug products, long-term and accelerated drug product stability studies according to ICH guidelines, Pen Device Assembly and release of the drug products as per ISO standards. Using a Quality by Design (QbD) approach, we evaluate and characterize unit operations, and choose the best materials/parameters to ensure successful drug product manufacturing.
Vials
Unit 2 and Unit 3
Facility
Bausch Strobel and Tofflon filling line integrated with isolator and lyophilizer
Equipment
1 – 100 ml
Fill Volume
400 million
Annual Capacity
Pre-Filled Syringes
Unit 2
Facility
Bausch Strobel filling line integrated with isolator
Equipment
0.5 – 10 ml
Fill Volume
28 million
Annual Capacity
Cartridges and Pen device assemblies
Unit 2
Facility
Bausch Strobel filling line integrated with isolator
Equipment
1.5 – 3 ml
Fill Volume
40 million
Annual Capacity
