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Whether you require assistance in transitioning from milligram to kilogram scales or seek a discrete work package to achieve your upcoming milestone, our proficient team of process chemists is poised to accelerate your project. We meticulously balance cost, quality, and time to guarantee the creation of a purpose-fit chemical route. Our cutting-edge manufacturing facilities which are MHRA accredited, play a pivotal role in supporting the seamless delivery of your API.
Designing and planning an effective route is key for API manufacture. A good route will de-risk your asset and facilitate the rest of your development journey.
Experience: We’ve brought 21 candidates to the clinic for our clients in the last 10 years
Expertise: Based in Sandwich and Chapel-en-le-Frith, UK, we recruit and develop staff from a thriving chemistry ecosystem.
Capabilities: Our ability to work with a wide range of chemistries, including high potency APIs, steroids, carbohydrates, and nucleosides/tides, is second to none
Quality Manufacturing:
Analytical and Material Science:
Regulatory Engagement:
A good route that fulfils the SELECT criteria lays the foundation for a future scale up campaign. But good route design is one part of the puzzle – the other is process optimization, ensuring the chemistry is fit-for-purpose, whether a 100 g Toxicology batch or a multi kilo GMP delivery is required.
The importance of solid form in drug development cannot be overstated. We support salt and polymorph screening of APIs from the start. This can run alongside route development as a de-risking exercise or as a stand-alone service. It can also follow a large-scale synthesis campaign or be tailored to your needs.
Everything that we do is supported by analytics. Visit our analytical chemistry page to find out more.