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API Development and Manufacture – Early Phase

Process Development

We have significant experience in the first time scale-up of APIs. Starting with the medicinal chemistry route, our knowledgeable chemists can quickly identify the most pressing parts of the chemistry to develop.

The thermal safety of each process is assessed in-house by the DSC and ARSST and the heat of reaction data is measured by calorimetry. Purity control is assured by a combination of reaction progress control and the development of an effective and scalable purification strategy.

Our biocatalysis expertise is just one approach we take to identifying ways of introducing chirality.

Our chemists work closely with our development analysts and production teams to ensure that controls are appropriately embedded into the process IPCs, intermediate specifications, and processing instructions. The salt form and polymorph landscape are explored within our physical sciences teams and drive the development of the API isolation process, and particle size is controlled through our micronisation suite.

In addition to a wide range of API structural types, our highly skilled chemists have experience working with ADC linkers, warheads and linker-warhead combinations.

Additionally, we have extensive experience in the synthesis and analysis of stable and 14C isotope labelled compounds – from drug discovery through to launch. We can label any compound at any stage, including small molecules, peptides, and antibody drug conjugates.

Expert Analytical Development

Our strong analytical teams are experienced in the development and phase appropriate validation of sensitive and specific analytical methods. Our seasoned analysts work closely with our chemists to develop IPC, isolated intermediate, and stability indicating API methods. Underpinning this work is a strong investment in a wide range of analytical equipment, including ongoing investment in equipment and software that increases the efficiency of our analytical workflows.

We have vast experience in the development of highly sensitive methods to demonstrate control of potential GTIs. Our stability teams work alongside our development analysts, routinely running multiple parallel API and drug product stability studies.

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