This new state-of-the-art, flexible fill and finish facility, was acquired by Cobra from UniTech Pharma at the end of 2011 and expands the current service offering to include sterile drug product production and freeze drying / lyophilisation from clinical to commercial supply.
Medicines can be filled in either single-use syringes or injected vials while meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.
Project Management
Dedicated Project Manager
Multi-functional project teams
Detailed timeline planning and milestone tracking
Program managed by single point of contact
Regular process update through telecom or face-to-face meetings
Risk management
Aseptic pharmaceuticals manufacture
Batch sizes from 1 to 100 litres
Clinical and routine commercial scale supply
Sterile filtered (aseptic)
Capability for terminal sterilization by autoclave
Finished product can also be manufactured in frozen solution
Full disposable systems utilized
Freeze drying/ Lyophilisation
5,000 bottles/ hour (10 ml)/ batch
Syringes
Filling of pre-sterilized syringes (0.5 ml – 10 ml)
4,000 syringe units/ hour
Vials
Filling of vials (3ml – 100 ml)
3ml- 3600/hour
25ml- 3000/hour
100ml- 1000/hour
Pharmaceutical products can be both sterile filtered (aseptic) with also the capability to terminally sterilize by autoclave.