Biochemical Assay Case Study
CASE STUDY: Biochemical Assay Optimisation, Validation and Application
Build and validate an assay to measure non-haem iron in tissues thereby supporting one of the pivotal objectives for a regulatory non-clinical safety study.
UK Speciality-Pharma Company
A GLP-compliant assay for quantification of non-haem iron in liver, kidney and spleen was validated. Analysis of non-clinical samples was achieved. Results supported continued development of the molecule in question.
- Procedures for tissue extraction of non-haem iron were optimised and partnered with a colorimetric assay.
- Following validation, the assay was used to support a non-clinical study: non-haem iron was detected in all tissues and exhibited a dose-response.
- The data supported the aims of the study and proved the utility of a non-haem iron assay in a GLP setting.