CMC & Process Development
CMC & Process Development
Robust process chemistry and comprehensive CMC services to take your lead compound from the discovery lab to scalable, reproducible synthesis.
Route Scouting And 20L Scale-Up
Robust process chemistry and comprehensive CMC services to take your lead compound from the discovery lab to scalable, reproducible synthesis.
Comprehensive process chemistry and CMC expertise to build a robust, scalable synthetic route for your API.
Systematic evaluation of alternative synthetic routes to identify the most scalable, cost-effective, and safe pathway to your API.
DoE-driven optimization of reaction conditions, workup procedures, and crystallization to improve yield, purity, and robustness.
Comprehensive identification, characterization, and control of process-related impurities and degradation products.
Systematic scale-up execution from milligram discovery quantities to multi-gram development and clinical supply batches.
A structured approach to moving from first synthesis to a robust, regulatory-ready process.
Evaluate all viable synthetic routes. Score for scalability, safety, cost, and regulatory suitability. Select the preferred route for development.
Systematic investigation of critical process parameters. Establish design space for key reactions. Identify critical quality attributes.
Identify all potential impurities, establish fate and purge studies, develop control strategy consistent with ICH Q3A/B guidelines.
Develop and validate analytical methods for all quality attributes. Establish specifications aligned with regulatory expectations.
Execute scale-up batches with full documentation. Prepare batch records and process descriptions ready for manufacturing transfer.
Our process chemistry team brings the expertise to develop scalable, regulatory-ready processes for even the most challenging molecules.
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