Rob Crook, our Director of Chemical Science, explores the 3 CMC Challenges that can derail your programme's success, along with strategies on how you can overcome scale-up risks, complexity, and speed-vs-strategy pitfalls.
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Work-up
Discover how CatSci rapidly developed a robust and inherently safe process which enabled our customer to support their early clinical supply without surprises or delays.
The CatSci team was set the task of developing a robust scalable manufacturing process suitable for transferring to plant. Discover how they used Lumi, an AI computer vision tool, to monitor and record the reaction, which enabled us to make critical decisions more efficiently and effectively.
Org. Process Res. Dev. 2022
Org. Process Res. Dev. 2022, 26, 5, 1398–1404
Org. Process Res. Dev. 2022, 26, 5, 1458–1469
General points to consider on solvent selection for scale-up
Solvent Selection Considerations
Dr Alan Steven explains why environmental sustainability and “big picture thinking” should be key considerations when selecting solvents for scale-up.
CatSci was tasked with designing a new bromination method for a key reaction intermediate. Use of bromine rendered the previous process unsuitable for a larger campaign and would require expensive and time-consuming alterations to the plant.
The route supplied by the client involved the use of phenyl cyanate for functionalising a heterocyclic intermediate with a nitrile group. Its ongoing use would require cyanide monitoring, a dedicated waste stream treatment step, and there were concerns over the sourcing of material of appropriate quality over the long term.
CatSci was tasked with designing a new bromination method for a key reaction intermediate. Use of bromine rendered the previous process unsuitable for a larger campaign and would require expensive and time-consuming alterations to the plant.
CatSci was tasked with performing route-scouting, route selection and early-phase process development over a 6-month period to meet a pilot plant manufacturing slot.
CatSci was tasked with the development of a regioselective Buchwald-Hartwig amination for the final bond forming step of an API. The inherited conditions were not robust with respect to reaction conversion leading to stability concerns.
WO2020023438
Org. Process Res. Dev. 2020, 24, 6, 1131–1140
The importance of physical parameters
Our article offers tips on how to manufacture your API in the right quantity, at the right cost, and in the right time frame - and not burn your factory down in the process!
Some scale-up considerations
Optimisation of an Acid-mediated Rearrangement with DoE
Optimisation of an Asymmetric Hydrogenation