Quay Pharma’s expertise and GMP accredited state-of-the-art manufacturing facilities mean that it is uniquely placed to offer the development of crucial early stage clinical formulations and clinical manufacturing for First in Man (FIM) trials for live biotherapeutics.
Notably, Quay Pharma is the only FDA inspected CDMO currently licensed to supply complex finished dosage forms containing live bacterial strains for pharmaceutical clinical trials supply.
Quay’s fully equipped facilities enable the complete manufacture of a wide range of products for clinical trials and have the full capabilities to manage complex formulations under rigorous regulatory and quality managed procedures.
By developing live biotherapeutic formulations specifically designed to achieve a client’s targets during the first clinical evaluations, Quay Pharma is then able to scale up and provide clinical supplies of the formulation in the most appropriate form for Phases II and III in their dedicated, contained GMP suites.
The well-proven early-stage manufacturing technologies that Quay Pharma provides include:
- Micro dosing.
- Tableting, including mini tablets.
- Capsule Filling – granule, liquids, semi-solids, pellets.
- Coating of tablets and capsules.
- Granulated powder – for reconstitution, offered in bottle or sachet form.
- Topical and oral liquids.
Quay Pharma’s experts ensure that products are seamlessly scaled-up and transferred to clinical quantity manufacturing, providing comprehensive support to clients through the often complex process of licensing their product or moving on to Phase III or commercial contract manufacturing by writing technical transfer packages and offering practical advice whenever required.
To find out more about a First in Man (FIM) programmes and learn how Quay Pharma could take your live biotherapeutic to clinical trials, please contact Quay Pharma now.