Drug Development Office (DDO)
The Drug Development Office (DDO) has experienced and well-trained staff for managing all aspects of our drug development and early clinical trial portfolio and ensuring compliance with legal and regulatory requirements. Staff include:
- Project managers
- Clinical Research Associates
- Trial supplies specialists
- Data managers
- Database specialists
- Medical writer
- Pharmacovigilance manager
- Regulatory manager
- GCP manager
The DDO has in-house facilities for the manufacture and supply of investigational medicinal products for use in our trials. DDO has two facilities - the Formulation Unit at Strathclyde University in Glasgow, and the Biotherapeutics Development Unit (BDU) based at Cancer Research UK's London Research Unit just north of London. Both facilities are licensed by the MHRA for GMP production of IMPs.
The Formulation Unit primarily focuses on the analysis, formulation and production of small molecule drugs. It is shortly to move into a new state-of-the-art facility and can handle all classes of drugs including cytotoxic agents. The services it offers include:
- Analytical method development
- Full analysis and issue of certificate of analysis
- Physico-chemical characterisation
- Formulation development
- Stability studies
- Manufacture
- QP release
The BDU focuses on the production of biological agents for use in DDO clinical trials. It can produce antibodies, plasmid DNA and recombinant proteins, but at present cannot produce viral vectors. The services it offers include:
- Cell banking
- Process development - upstream and down-stream processing
- Analytical method development
- Full analysis and issue of certificate of analysis
- Stability studies
- Manufacture
- QP release
The DDO is subject to regular audits by its own internal audit group, collaborating companies and regulatory inspections by the MHRA, thus ensuring that it operates to current legal requirements.
For further details on the Drug Development Office, visit the DDO microsite.
