Drug Development

New Drug Development and Scale-up
IDT provides support services for new drug development and scale-up projects through its newly upgraded laboratory facilities. These facilities are divided into two areas: Research and Development (R&D) and Analytical.

Features of the R&D laboratories and services provided:
Development and optimisation of the synthesis of API’s;
Containment facilities for synthesis of highly toxic and highly potent materials;
Manufacture of new API’s to GLP standards suitable for preclinical and toxicological testing;
Scale-up of API manufacture to GMP standards for clinical use;
Formulation development;
API process validation to FDA standards;
Synthesis of Reference and Impurity standards.

Features of the Analytical Laboratories and services provided:
A high level of expertise in the development of analytical methods for both pharmaceutical quality control and stability testing. Equipment includes gradient HPLC systems fitted with diode array UV detectors to enable development of stability indicating methods;
Validation of analytical methods to current ICH and FDA standards;
Stability testing of both API’s and finished dosage forms. (Stability chambers at ICH temperature stations);
Impurity identification by HPLC-MS;
Analysis of residual solvents using a capillary GC fitted with a headspace autosampler;
Containment laboratories to enable analysis of highly toxic or highly potent products.