Process Development

Purpose & What We Do

• •Optimize the selected synthetic route for performance, yield, impurity profile, scalability, and containment
• •Define Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and establish control strategies

• •Lab / pilot scale optimization: reaction conditions (temp, time, concentration), solvent selection, reagent equivalents, catalysts, purification procedures
• •Developing purification / isolation strategies tailored for HP compounds (e.g. minimizing cross-contamination, ensuring deactivation of residual HP residues)
• •Mechanistic / kinetic studies, determining reaction order, rate-limiting steps
• •Analytical method development and validation (for potency, purity, residuals)

• •Fully optimized synthetic process with defined CPP ranges
• •Analytical methods for release AND in-process testing
• •Pilot batches for scale-down / scale-up studies
• •Process safety plan (including handling, containment, waste management)