Process Chemistry 

Developing a robust and scalable process is essential for transforming a medicinal chemistry type of synthesis into a viable route for large-scale manufacturing. At Enantia, we have over two decades of experience in route scouting, optimizing reaction conditions, reducing transformations, and improving step efficiency. As a result, we deliver processes with enhanced yield, purity, scalability, and cost efficiency.

Our Process Chemistry team ensures a seamless transition from lab-scale synthesis to industrial production. For this, we focus on key aspects of Chemistry, Manufacturing and Control (CMC) development, cost efficiency, sustainability, and process safety.

Chemical reactor at Enantia for process chemistry CRO services, including route scouting and route optimization, impurity profiling, scale-up, and custom synthesis.
Our process chemistry services include:
  • Route Design and Route Scouting: Proposing efficient, innovative, safe and scalable synthetic routes.
  • Process Optimization: Performing optimization and fine-tuning of reaction parameters to maximize efficiency, ensure high purity, and facilitate scale-up.
  • Critical Process Parameter (CPPs) Identification: Identifying and understanding the key variables within the chemical process that have a direct impact on the critical quality attributes of the final product — such as purity, yield, particle size, or polymorphic form.
  • Proven Acceptable Range (PAR) and Normal Operating Range (NOR): Establishing acceptable conditions for consistent production quality and determining process robustness.
  • Impurity Studies: Isolation, identification, and synthesis of impurities and their standards, including nitrosamines and Out of Specification (OoS) impurities. Carry-over, spiking and impurity profiling to support CMC documentation.
  • Scale-Up: From lab-scale to kilo-lab custom synthesis, delivering batches for preclinical and GLP studies.
  • Technology Transfer: Packages including comprehensive CMC–compliant documentation to ensure smooth process transfer to larger scale manufacturing.