Drug Development Office

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 is a state-of-the-art facility capable of developing and manufacturing biological agents for use in DDO clinical trials. It can produce antibodies, plasmid DNA and recombinant proteins and 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.

See Cancer Research UK Funding & Research for more information about the Drug Development Office.