Our work and case studies

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:

Analysis of Insulin Analogues Case Study

Challenge: A client has developed new product to fulfil an unmet patient need. Pivotal clinical studies require highly sensitive, precise measurement of multiple insulin analogues

Drug Substance Salt Selection Case Study

Challenge: To manufacture drug substance and screen a selection of corresponding pharmaceutically acceptable salt forms.  From the resulting salt forms, choose a candidate wh

Analytical & Microbiological Support to Clinical Research Unit

Challenge: Development and validation of analytical and microbiological methods for Intravenous (IV) products manufactured extemporaneously (EP) at Clinical Research Unit. Testing

Radiosynthesis via Chemically Unstable Intermediate

Challenge: Process chemistry route to API required hydrogenation, then salt formation. The hydrogenation product was chemically unstable until the salt was formed. On a large scal