Process Research and Development

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.

Route Design 

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.

What Makes Us Different

• We utilize SELECT criteria and Green Chemistry principles to evaluate best routes towards the API
• Our investment into process safety ensures we deliver safe and robust

Experience: We’ve brought 21 candidates to the clinic for our clients in the last 10 years

Expertise: Based in Sandwich UK we recruit, retain, 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: Our facilities (established to large pharma standards) are MHRA accredited. Processes for clinical and commercial manufacture have been successfully audited by our global customer base

Quality Manufacturing:

• API synthesis for PK studies, GLP Tox, and clinical trials
• Continuous process de-risking

Analytical and Material Science:

• Phase-appropriate development & validation
• Support with IMPD / IND filing

Comprehensive Pre-clinical Evaluation:

• Safety, efficacy, and pharmacokinetics assessment

Regulatory Engagement:

• Open communication with agencies
• Early issue identification and resolution

Process Optimization 

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 tox batch or a multi kilo GMP delivery is required. 

Our Expertise 

• Deep experience in the optimization of reactions, work ups and purifications, including removing chromatography, help to identify hold points, simplify workflows, and streamline processes.
• Application of Design of Experiment software and parallel screening equipment helps to maximize yields, improve reaction robustness and de-risk future scale up campaigns by understanding the impact of variables, thus allowing a suitable reaction parameter window to be identified.
• A range of jacketed vessels allow large scale reaction conditions to be trialed on a small-scale saving time and precious material.

Materials Science 

The importance of solid form in drug development cannot be understated. We can support both salt and polymorph screening of API at the onset of the project, in parallel with route development as a de-risking exercise, as a standalone service, as a bolt-on following a large-scale synthesis campaign or anything in between. 

• This can be offered as part of a development project or standalone service. 
• A wide range of equipment including the Technofix Crystal16 and HEL Polyblock reaction center support both salt formation and polymorph screening. A suite of jacketed vessels offers proof-of-principle and the ability to take crystallization from milligram to multi-gram.  
• Cutting-edge solid form analytical equipment, including the gold standard PXRD provide solid form insight and can help solve problems.

Analytical Method Development and Validation 

Everything that we do is supported by analytics. Visit our analytical chemistry to find out more.