AI-Driven · CMC & Process Development

CMC & Process
Development

AI-driven route scouting and robust process chemistry to take your lead compound from the discovery lab to a scalable, reproducible synthesis — with step-wise cost workbooks and scale-matched routes (lab · kilo · commercial). Automation makes us fast; expertise makes us right.

Process Development Services

Build a robust, scalable route to your API

Route Scouting

Alternative routes proposed and evaluated for the most scalable, cost-effective and safe path.

  • AI-driven retrosynthetic analysis
  • Literature & patent landscape review
  • Feasibility studies for key steps
  • Route risk assessment

Process Optimization

Improve yield, purity and robustness.

  • Solvent & reagent screening
  • Temperature & time optimization
  • Workup & isolation improvement
  • Crystallization development

Impurity Profiling

Identify, characterize and control impurities.

  • Process-impurity ID (LC-MS / HRMS)
  • Impurity synthesis & characterization
  • Fate & purge studies
  • Genotoxic-impurity assessment

Scale-Up (mg → multi-kg)

Systematic execution from discovery to development quantities.

  • Laboratory to pilot scale
  • Scale-up risk identification
  • Heat & mass-transfer considerations
  • Clinical-supply batches

Cost & Process Workbooks

Step-wise costed workbooks for route selection.

  • Route-vs-route economics
  • Dominant-cost-driver analysis
  • Multi-tab schemes & conditions
  • Current-vs-recommended options

Non-Infringing Routes

Disconnection diversity and IP-landscape-aware design.

  • Alternative disconnections
  • Patent-grounded generic routes
  • IP-aware (informational, not legal FTO)
  • Ready for scale-up
7.4% → 24.6%
Overall Yield · ~3.3×

A step-wise cost workbook flagged the dominant cost driver on an oral PROTAC route; a late-stage asymmetric-hydrogenation strategy change tripled the end-to-end yield.

Development-Stage Progression

First synthesis to regulatory-ready process

  1. 1

    Route Assessment & Selection

    Score viable routes for scalability, safety, cost and regulatory suitability.

  2. 2

    Process Understanding

    Investigate critical process parameters; establish a design space for key reactions.

  3. 3

    Impurity Control Strategy

    Identify, track and purge process-related and genotoxic impurities.

  4. 4

    Scale-Up Readiness

    Scale-matched conditions and documentation, ready for manufacture.

Let's design your next route.

Bring us a target — known or novel. We return scale-matched, costed, verified routes your team can act on.

Start a Project