Our process & scale-up chemistry team has over 100 years of combined experience. The team strives for and maintains excellence in pre-clinical process research and chemical development, enabling a smoother transition between medicinal chemistry and pilot-scale manufacture.
Charnwood Discovery’s dedicated group of process and scale-up chemists are able to work with clients from the outset to think ahead to the unique demands and challenges of chemical development. It is vital to ensure that pre-clinical supply is forthcoming at the appropriate stage, and to speed up and reduce the costs of an eventual clinical supply.
We work with you at early- or late- stage chemical development ensuring you get the best out of the scale-up process, taking your route from milligram to kilogram scale. The team’s considerable experience is also evident in the synthesis of key intermediates and active pharmaceutical ingredients for pre-clinical toxicological studies.
Process Development
Early process development involvement in any drug discovery program can often lead to considerable long-term benefits such as a shorter development time to key materials and implementation of routes more amenable to scale-up, potentially shaving months off any drug discovery program.
At Charnwood Discovery we further develop the route to your drug candidate by ensuring a robust and scalable route amenable to pilot-scale manufacture.
Staying abreast of the most cutting edge and current literature allows our process and scale-up chemists to construct your target molecules and include a cost of goods analysis and green chemistry metrics.
Impurity Synthesis
At Charnwood Discovery we have a long history of supporting pharmaceutical manufacturing through the identification, isolation, and synthesis of process impurities, often in support of analytical development and for regulatory requirements.
Additionally, we can study the origin and fate of process impurities conducting sample spiking and purging experiments to further improve process robustness.
Chemical Manufacturing
At Charnwood Discovery we have been synthesizing key intermediates, building-blocks and API for 25 years.
Using a combination of thoughtful route selection and rapid route development, from round bottom flask to jacketed vessel, we can deliver your desired molecule anywhere from 1 g to 1 kg.
Our chemical development team can perform the synthesis in our state-of-the-art Radley’s Reactor Ready Jacketed vessels ranging from 1 L to 20 L, with cryogenic processes possible. For thermal safety considerations we have a DSC in-house, allowing our team to make the safest decisions as your project progresses.
In support, we also have capabilities in electro- , flow- , photo-, and high-pressure chemistry plus an OEB4 facility.
Crystallization and Purification
To support isolation of large quantities of material, we utilise a Technobis Crystal16 crystallizer to determine solubility profiles of materials of interest. With as little as 100 mg of sample solubility curves can be generated. We have used this to great effect to successfully eliminate silica gel chromatography from key reaction steps. For solid form studies, we partner with Solitek.
When chromatography is required, our Teledyne Torrent can be utilized to purify hundreds of grams of material at a time, using up to a 3 kg pre-packed silica gel cartridge.
Reaction Screening
Analytical Method Development
We have a dedicated, in-house, analytical chemistry team to support drug discovery projects from hit identification through to commercial release. We can develop and validate analytical methods in-house and support the transfer of these methods to GMP/GLP laboratories.
Our analytical scientists also provide a purification service capable of delivering purifications on a milligram to multigram scale. The team has significant expertise in impurity isolation.
The timeley and successful development of the chemistry for the synthesis of ANT3273 has facilitated the preclinical studies for this potential drug.
The expertise and flexibility of Charnwood Discovery has made them one of our key partners for chemisty."
Continued support of the program has enabled efficient technical transfer of the process to larger scale. GMP versions to meet the growing API needs of the program as we progress into later-phase clinical development."
Regular, clear and concise information was appreciated."
