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.

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