R&D Process & Scale-Up Pathway

A systematic, stage-gated development journey from laboratory concept to commercial reality

Lab Research
2 - 4 Weeks
Route scouting, literature review, feasibility assessment. 1 g - 100 g scale synthesis for proof-of-concept and preliminary characterization.
Process Development
4 - 12 Weeks
Route optimization, DoE (Design of Experiments), impurity profiling, and process parameter definition. 100 g - 5 kg scale for parameter validation.
Pilot Scale-Up
8 - 16 Weeks
Kilogram to 50 kg scale demonstration runs in pilot plant. Process safety assessment, solvent recovery, and engineering data collection.
Validation Batches
4 - 8 Weeks
GMP validation batches with full analytical release. Process capability analysis (Cpk), cleaning validation, and regulatory documentation preparation.
Commercial Production
Ongoing
Metric-ton production under full GMP with continuous process monitoring, annual product quality review (APQR), and lifecycle management.

Customization & Co-Development Services

How we partner with clients to turn concepts into commercial products through collaborative development

The Co-Development Journey

01

Technical Consultation

Initial engagement to understand your target molecule, specifications, timeline, and budget. Our scientists assess feasibility against our technology platforms and provide a detailed technical proposal including synthetic route options, cost estimates, and development timeline.

02

Process Optimization

Joint optimization of the synthetic route with DoE-based parameter screening. We work iteratively with your team -- sharing analytical data, impurity profiles, and process safety assessments at each stage to align on critical quality attributes (CQAs) and critical process parameters (CPPs).

03

Sample Preparation

Rapid delivery of gram to kilogram quantities for your internal evaluation, formulation studies, and regulatory testing. Each sample is accompanied by a full analytical data package including CoA, HPLC/GC chromatograms, NMR spectra, and residual solvent/metal reports.

04

Commercial Transfer

Seamless technology transfer to commercial manufacturing with validated processes, full documentation packages, and ongoing technical support. We maintain a dedicated project manager as your single point of contact throughout the product lifecycle.

Co-Development Service Models

Custom Synthesis (FTE-Based)

Dedicated full-time equivalent (FTE) scientists assigned to your project for a defined period. Ideal for early-stage discovery support, route scouting, and library synthesis where flexibility and rapid iteration are priorities. Weekly progress updates and real-time data sharing via secure portal.

Process Development & Scale-Up

End-to-end development from bench-scale feasibility through pilot demonstration and commercial scale-up. Includes process hazard analysis (PHA), design space definition, control strategy development, and technology transfer documentation. Suitable for late-stage clinical and commercial programs.

Quality & Regulatory Support

Comprehensive CMC support including impurity identification and qualification, reference standard preparation and certification, forced degradation studies, ICH stability testing (long-term, accelerated, intermediate), DMF preparation and filing, and responses to regulatory agency queries.

Toll Manufacturing

Utilize our manufacturing assets under your quality system. We provide reactor capacity (glass-lined, stainless steel, Hastelloy), isolation equipment, and analytical support while you retain full IP ownership and supply chain control. Flexible capacity from pilot to commercial scale.

Integrated Supply Solutions

Combine custom synthesis with our existing catalog of 500+ intermediates to create a streamlined supply chain. We manage multi-step synthesis across our partner network, providing a single point of accountability for complex supply chains with full traceability from raw material to final product.

Lifecycle Management

Ongoing support beyond launch: process improvements for cost reduction (COGS optimization), second-source qualification, supply security planning, regulatory change management, and sunsetting strategy. We treat every product as a long-term partnership, not a one-time transaction.