Process Research & Development

Route design

Designing and planning an effective route is key for API manufacture. A good route will facilitate the rest of your development journey and avoid dead-end unscalable synthetic routes.

• Considerable expertise utilising the SELECT criteria and applying Green Chemistry principles mean routes are designed to be scalable and have the minimum environmental impact.
• Investment in process safety equipment including DSC, TSU and Calorimetry facilitates the identification of suitable safety windows. Click here for more information on our PR&D capabilities.
• Concept Life Sciences’ chemists have made the final of the annual RSC/SCI retrosynthesis competition five of the last seven years demonstrating consistent, world-class problem-solving skills.
• Access to the latest literature and reaction databases support scientific thinking and allow synthetic protocols and methodologies to be updated accordingly.

Process optimisation

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 optimisation, ensuring the chemistry is fit-for-purpose, whether a 100 g tox batch or a multi kilo GMP delivery is required.

• Deep experience in the optimisation 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 maximise 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 trialled on a small-scale saving time and precious material. Click here for more information on our PR&D capabilities.

‍

Crystallisation and solid form

The importance of solid form in drug development cannot be understated. Concept Life Sciences can support both salt formation 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.

• A wide range of equipment including the Technobis Crystal16 and HEL Polyblock reaction centre support both salt formation and polymorph screening. A suite of jacketed vessels offers proof-of-principle and the ability to take crystallisations 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. Click here for more information on our analytical and solid form capabilities.
  
  

Analytical method development & validation

Everything that Concept Life Sciences do is supported by analytics. Close collaboration between the chemistry and analytical teams – as early as possible – is the most efficient way of supporting API development.

• Expertise in method development & validation using complementary analytical techniques to offer insights and support impactful, data-driven decision making. Click here for more information on our analytical and solid form capabilities.
• Close collaboration with chemists to support in-process method checks to track and monitor the formation and purge of impurities throughout a synthesis.
• A firm understanding of the regulatory requirements support the generation of detailed data packages in turn, supporting GMP batch release and IND applications.
• We offer forced degradation and ICH formal stability studies.