After successfully establishing our clinical trial manufacturing capability, in 2014 we were granted a commercial manufacturer/importer’s license by the MHRA for the GMP-manufacture of aseptically-filled licensed commercial products.
The license effectively enables us to offer exactly the same sterile product filling offering as we do for clinical trials, but for licensed products. We can therefore cater for the small scale commercial manufacturing of licensed biologic and small molecule products into vials.
Our commercial scale services are ideally suited for companies involved in niche markets and orphan indications that require relatively low volume or infrequent sterile filling to meet patient demands.
We can fill bulk liquid volumes under 100 litres, including products that require aseptic liquid filling and lyophilisation. These include:
- Biologics including mAb’s, proteins, peptides and RNA
- Cytotoxic, cytostatic and high potent APIs including ADCs
- Small molecules
- Our manufacturing capability is supported by a full range of associated analytical and drug product testing services.
As part of our commercial set-up, we always aim to meet the gold standard regulatory compliance guidelines demanded by the MHRA with respect to product manufacturing, segregation and storage.
So if you need to outsource the manufacture of your injectable product to support your niche pharmaceutical product, then contact us today. Even if we can’t satisfy your quantity requirements, we will aim to point you in the direction of a reputable CMO that can.