The Eurofins CDMO, India facility successfully completed a complex process chemistry pathway for its US based partner. The scope of the project was to develop a robust process while controlling impurities to minimum. Our team completed 14 steps complex chemistry involving Suzuki and Chan Lam coupling, salt selection and polymorphic screening based on thermodynamic solubility, hygroscopicity etc. Team also supported customer with CMC documentation to file IND.
Our team improved the turnover number and turnover frequencies in Suzuki and Chan Lam coupling, customized the catalyst for site selective reduction. We also developed seeding crystallization by determining the Metastable Zone Width (MSZW). With all this the scientists were able to improve the overall yield by 9% and control heavy metals within ICH limit without using any metal scavengers.
With excellent problem-solving skills and expertise the team was able to deliver high quality Drug Substance on time. To our partners delight we were able to deliver extra quantity within reduced timeline, hence being a CDMO of choice for our partner.