Clinical Manufacturing Microbiome Therapeutics
SGS Quay Pharma's expertise and GMP-accredited state-of-the-art manufacturing facilities mean that we are uniquely placed to offer the development of early-stage clinical formulations and manufacturing for First in Human (FIM) trials.
Notably, SGS 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.
SGS Quay Pharma'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 microbiome therapeutic formulations that are designed to achieve a client's targets during the first clinical evaluations, SGS Quay Pharma can scale up and provide clinical supplies of the formulation in the most appropriate form for Phases II and III in our dedicated contained GMP suites.
SGS Quay Pharma’s experts ensure that products are seamlessly scaled-up and transferred to clinical quantity manufacturing.
Continuous and comprehensive support is provided through the often complex process of licensing their product or moving on to Phase III or commercial contract manufacturing. SGS Quay Pharma deliver writing technical transfer packages and offers practical advice whenever required.
To find out more about a First in Human (FIH) programmes and learn how SGS Quay Pharma could take your microbiome therapeutics to clinical trials, please contact us today and let's talk project success.
The well-proven early-stage manufacturing technologies that SGS Quay Pharma provides include:
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.