Sterile fill
  • 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