- Project: Medicinal chemistry
- Lead: Prof K Dhaliwal, Dr E Scholefield
- Start date: 1 September 2021
- PSH Theme: Therapeutics
Medicinal Chemistry and Sterile Fill
We have the capability to synthesise and certify new compounds for administration in humans.
We have developed a pathway for translational clinical studies in Edinburgh with full investigational supplies capability (GMP storage, labelling and QP release) and also small scale API and product fill capability
- in-house pharmaceutical grade sterile-fill facility
- safely deliver new medicines to humans
We can manufacture these reagents in-house, to clinical grade and at scale, enabling thousands of clinical assays in a micro-dosing delivery regime.
The team has already produced several molecular reagents that have been tested in first in- human trials, including technologies for imaging of bacterial pathogens and enzymatic activity in the alveolar space.
Our chemistry laboratory provides a suitable environment for the preparation of active pharmaceutical ingredients (API) for phase 0/1 clinical studies.
The chemistry laboratory is aligned with principles of Good Manufacturing Practice (GMP). The sterile fill unit is a fully GMP compliant MHRA licensed facility, operating under a comprehensive quality system.
Activities at the chemistry laboratory include:
- development of synthetic pathways for the manufacture of chemical probes or APIs,
- manufacture and analysis of chemical probes or APIs
- stability and in vivo toxicological studies