Case Studies

Chromatographic Development & Application Case Study

Department: CMC
Customer: Multinational Consumer Goods Company
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 each of their associated impurities / degradation products.

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Accelerated Manufacturing Case Study

Department: CMC - Manufacturing
Customer: Japanese Big-Pharma Corporation
Challenge: Very tight deadline; from dose determination to manufacture and to patient administration within 4 days.

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Biochemical Assay Case Study

Department: DMPK
Customer: UK Speciality-Pharma
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.

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API Development Case Study

Department: API Development
Customer: US Biotech
Challenge: Rapid development of a scalable route towards an analogue of a new drug substance, with definition of an optimal salt form for formulation.

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Analysis of Insulin Analogues Case Study

Department: DMPK
Customer: European Biotech Company
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 from a small volume of plasma.

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Thermal Rearrangement - Continuous Flow Case Study

Department: API Development
Customer: US Biotech
Challenge: A technically challenging and labour intensive process in batch with a typical yield of 50% and a poor impurity profile.

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Stable Isotope Labelling Case Study

Department: ICMS
Customer: Multiple biotechnology and Big-Pharma clients
Challenge: MPK and Bioanalysis need to quantify parent and metabolite drug concentrations in biological samples from non-clinical and clinical trials.

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Drug Substance Salt Selection Case Study

Department: CMC - Formulation
Customer: US Pharmaceutical
Challenge: Manufacture drug substance and screen a selection of corresponding pharmaceutically acceptable salt forms. From the resulting salt forms, choose a candidate which exhibits optimal characteristics for formulation and bioavailability.

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Analytical & Microbiological Support to Clinical Research Unit

Department: CMC - Microbiology
Customer: UK Clinical Research Unit
Challenge: Development and validation of analytical and microbiological methods for Intravenous (IV) products manufactured extemporaneously (EP) at Clinical Research Unit.

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