Project challenge: Identication of suitable chiral reagent for chemical resolution, process validation, desired polymorph. Solution design: Often API development is bound by IP constraints. In order to develop a scalable and robust process to address IP challenges, the following approach was adopted by the CPS team. Non-infringing route to circumvent IP barrier was proposed Screening of chiral resolving agents and solvents to yield the maximum eciency in terms of yield and highest desired enantiomer Polymorph screening with dierent solvent systems and a range of temperatures furnished the requisite Process developed in lab was demonstrated in plant by performing three process validation batches yielding the product with desired quality and culminating in regulatory filingConclusion: Our team has demonstrated the ability to develop processes for commercial API that are already in the market with restrictions in IP and enable the submission of a regulatory filing.
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