QA and Control

The BDU's QA/QC function has been developed to give the highest possible assurance that products manufactured by the BDU are safe, efficacious and of the highest quality.

A robust quality system is in operation. The BDU has its own onsite Qualified Person (QP), responsible for the manufacture of biologicals sponsored by Cancer Research UK.

Regulation and Guidelines

• European Clinical Trials Directive (2001/20/EC)
• EUDRALEX: Volume 4 medicinal products for human and veterinary use.  Good manufacturing practice.
• The rules and guidance for pharmaceutical Manufacturers and Distributors, and the principles of good laboratory practice.

The Quality Control lab uses a range of assays to determine the sterility, purity, identification, specificity and conformity of the drug products.

Assays routinely used in QC are electrophoresis (SDS-PAGE, IEF, AGE), HPLC (Size Exclusion, Ion Exchange), ELISA, LAL (Endotoxin Assay), Bioburden and pH.

The QC department has the capability to establish and run stability trials on final products.

All assays are standardised and controlled.