Within our dedicated development facilities, we have cleanrooms for the cGMP production of solid, liquid and semi-solid formulations and a sterile suite for the production of sterile vials. Our development facilities allow us to cater for a range of clinical trials from preclinical to smaller Phase III trials. Efficient sourcing of raw materials guarantees that there are no unnecessary delays. For very large clinical batches we can arrange manufacture in one of our commercial manufacturing units. So whatever stage you’re at, we can support your project.
Non-sterile clinical trial production
Our labscale equipment is suited to your preclinical or Phase I material. The pilot-scale equipment is suitable for Phase II and smaller Phase III trials. The dosage forms range from pure API in capsules or granulates in sachets, to more advanced controlled release products. For coated pellets we have a specialised development unit where we have the ability to produce GMP batches for clinical trials from Phase I to full commercial batch size.
Sterile clinical trial production
Our sterile suite consists of a Grade C area where the solution preparation takes place. This includes the rinsing of vials and the loading of the autoclave and dry heat steriliser. Grade B is compatible with a filling machine (ROTA), a crimping machine and an LAF (Holten) for manual filling.
The size of this sterile suite is perfect for customers looking for smaller batches. The ROTA filling machine is validated for 10, 20, 50 and 100 mL vials. The batch size is limited by the dry heat steriliser with room for approximately 700 of 100 mL vials and up to 3000 of 10 mL vials. If hand-filling is required for small batches, unusual containers, sensitive or very expensive material, this can be done in our LAF, Grade B.
Our Part 11 validated Facility Monitoring System keeps track of temperature, humidity and pressure as well as recording particles, online. We also have in-house WFI and clean steam.
Packaging and labelling
We perform packaging and labelling of active and placebo material as needed for your trial.
Our development units have onsite QC labs working in close collaboration with the analytical chemists that develop our analytical methods.
We have in-house QA and QP who are accustomed to clinical trial material and the diversity between one batch and the next. We perform QP release and we can offer audits of DS suppliers.
Clinical trial distribution
Storage and distribution services for clinical trials are offered in collaboration with a partner. This includes distribution all over the world through a network of depots in four continents.