HPAPI Process Development

Overview

We provide end-to-end HPAPI services from early route identification through commercial-scale cGMP supply. Our facilities include multiple dedicated HPAPI suites (OEL / OEB compliance), isolator technology, enriched analytical lab support, and a robust payload/linker library. We support both oncology & non-oncology high potency compounds.

2. 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

Key Activities

•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)

Deliverables

•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)

Process Research Focus Areas

•Catalyst and reagent screening
•Asymmetric and chiral synthesis
•Solvent selection
•Yield improvement

Scale-Up Pathway

Process development at Shilpa follows a defined scale-up pathway from laboratory to kilo lab to pilot to commercial scale, with process safety assessment and thermal hazard evaluation performed at each stage.

Process Development