Our work and case studies

API Manufacture, Formulation Development, Capsule Product Manufacture Case Study

Challenge: Accelerate first-in-human and Phase II trials for an oral dosage form intended for treatment of CNS disorders. A fully integrated approach was required, to incl

Accelerated Development to Clinical Studies Rapid Manufacture - Precision Filling Case Study

Challenge: To rapidly manufacture a GMP-compliant API-in-capsule product for use in Phase I and Phase II clinical trials.  The product was being investigated for trea

Intravenous Formulation Phase 1 Study Challenge Case Study

Challenge: To develop stable sterile formulations of a drug substance for intravenous administration in phase I clinical trials.  The drug substance, intended for the

Chromatographic Development & Application Case Study

Challenge: Development of a modern, single, chromatographic procedure for a marketed tablet product that would allow the resolution and quantification of four active species and e

Biochemical Assay Case Study

Challenge: 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.

Accelerated Manufacturing Case Study

Challenge: A strategy of rapid clinical progression – dose determination to manufacture and to patient administration within 4 days, necessitating a timeline of dose determinati

API Development Case Study

Challenge: Rapid development of a scalable route towards an analogue of a new drug substance, with definition of an optimal salt form for formulation Customer:

Thermal Rearrangement - Continuous Flow Case Study

Challenge: Thermal rearrangement of 7.5 kg of an API intermediate – A technically challenging and labour intensive process in batch with a typical yield of 50% and a poor impuri

Stable Isotope Labelling Case Study

Challenge: MPK and Bioanalysis need to quantify parent and metabolite drug concentrations in biological samples from non-clinical and clinical trials. Customer: