Cancer Research UK Analytical testing
The Cancer Research Formulation Unit has dedicated analytical laboratories for tests carried out from the pre-formulation to the post-production stages of drug development.
Tests include:
- characterisation of raw drug materials
- final product Quality Control (QC) tests
- stability profiling and drug expiry date extension.
1. Analysis of the raw drug (that is, the pure, unformulated active pharmaceutical ingredient) is made to ensure consistency between manufactured batches. This includes detection of possible impurities such as synthetic intermediates and manufacturing reagents (including solvents and heavy metal catalysts).
Testing methodologies are developed and validated in-house. For the raw materials a Certificate of Analysis is established: that is, a series of tests designed to assess the suitability of the material for human use. The assessment criteria are based upon the available ICH and pharmacopeial guidelines, and the route of administration and clinical requirements of the drug.
2. Quality Control (QC) tests fall into three categories:
i. chemical testing, including chromatographic analysis, pH, water content and osmolality
ii. physical testing, including particulate counting, dissolution and disintegration testing
iii. biological testing, including microbiological and endotoxin/pyrogen testing for parenterals.
3. Raw drug materials and final products are stability tested. This is to ensure that the shelf life of any product can be reliably predicted and that, should degradation occur over time, the products can be identified and defined.
Analytical equipment includes:
- HPLC's
- Capillary Electrophoresis with mass spectrometer interface
- Ion trap LC mass spectrometer
- Densitometer
- FTIR (with attenuated reflectance capability)
- Osmometer
- Melting point apparatus
- Head space gas chromatography
- UV spectrometer
- Dissolution testing apparatus
- Karl Fisher titrimeter
- Conductivity meter