Clinical trial manufacturing
We hold an MIA (IMP) license for the manufacture, testing and certification of products for use in human clinical trials and we have equipment suitable for provision of IMP’s for Phase I and Phase II studies.
Xcelodose®
API into capsule shells using our Xcelodose® precision powder dispenser. Xcelodose® is a precision powder micro-doser that can accurately fill capsules or vials with just the drug material alone and therefore requires no initial formulation development, allowing rapid progress to the clinic leading to a shorter drug development process by reducing the need for expensive and time-consuming stability studies. This in turn, reduces the time taken to reach the ‘first in human’ clinical trial decision point, which facilitates a significant increase in throughput of candidate compounds for development.
In addition to dramatic time-frame reduction, the system offers highly consistent dose accuracy and operates with generation of very little waste. The system can be easily contained to prevent operator exposure. This is particularly valuable for supporting development of drugs which are highly potent and toxic, such as oncology drugs.
- Phase I & IIa clinical trial manufacture
- IND / IMP / CTD drafting support