Thanet Labs is developing a clinical trial supply capability for sterile peptide investigational medicinal products (IMPs). This service is planned, not yet active. It is subject to the grant of a Manufacturer’s Investigational Medicinal Products Licence (MIA) from the MHRA. Organisations planning peptide-based clinical programmes are invited to register interest and discuss requirements ahead of service launch.
Background
The supply of sterile peptide investigational medicinal products for UK clinical trials is a specialist area with limited domestic manufacturing capacity. Sponsors running Phase I and Phase II peptide trials frequently face long lead times, complex cross-border logistics, and limited visibility over the manufacturing process.
Thanet Labs is building a UK-based sterile IMP manufacturing capability designed specifically for peptide programmes. The planned service will cover aseptic fill and finish, lyophilisation, GMP batch documentation, clinical trial labelling, and Qualified Person (QP) release — providing sponsors with a single UK manufacturing partner from IMP production through to site delivery.
Planned Scope
The planned clinical trial supply service will encompass the manufacture of sterile peptide IMPs in liquid and lyophilised presentations, clinical trial labelling to Annex 13 and UK CTR requirements, and QP release of IMP batches for use in UK and EU clinical trials. Batch documentation will be compiled to GMP standards and structured to support IMPD submissions.
Thanet Labs does not perform peptide synthesis. Sponsors supply the bulk peptide API, and Thanet Labs provides the downstream manufacturing infrastructure. The service is intended for Phase I and Phase II programmes at development and small-scale clinical supply volumes. Larger Phase III supply requirements will be assessed on a case-by-case basis.
Planned Capabilities
Authorisation basis
Manufacturer’s Investigational Medicinal Products Licence (MIA) — planned
Product types
Sterile peptide IMPs, lyophilised IMPs, small molecule IMPs
Trial phases
Phase I and Phase II supply — planned scope
Batch documentation
GMP batch records, certificate of analysis, IMP release documentation
Labelling
Clinical trial labelling to Annex 13 / UK CTR requirements
Comparator supply
Under evaluation
QP release
Qualified Person release for IMP batches — planned
Regulatory support
IMPD section support available on request
All parameters are indicative and subject to change pending MHRA MIA grant. This service is in development and not yet commercially available. Thanet Labs welcomes early-stage conversations with sponsors planning peptide-based clinical programmes.
Register Interest
If you are planning a Phase I or Phase II peptide clinical trial and are looking for a UK-based IMP manufacturer, Thanet Labs would welcome an early conversation. Registering interest now allows us to understand your programme timeline and ensure that our planned service is structured to meet your requirements. We aim to respond to all enquiries within two working days.
