Robust Processes for Seamless Commercialization
Transforming bench-scale chemistry into safe, scalable, and cost-effective manufacturing processes.
The transition from a medicinal chemistry route to a viable manufacturing process is one of the most critical stages in drug development.
Vikasith’s Process R&D team specializes in Route Scouting and Process Optimization, applying Quality by Design (QbD) principles to identify the most efficient, safe, and reproducible pathways.
Our focus remains on process safety, COGS reduction, and scalability, ensuring smooth technology transfer to our manufacturing partners.
Core Capabilities
Route Scouting & Selection
- Evaluation of existing routes for scalability & safety
- Design of novel non-infringing (NI) synthesis routes
Process Optimization
- Reaction screening (temperature, pressure, catalysts)
- Solvent selection & recycling (Green Chemistry)
Safety & Hazard Assessment
- Thermal screening & process safety studies
- Identification of critical process parameters (CPPs)
Scale-Up & Technology Transfer
- Bench (grams) to Kilo Lab (kilograms) scale-up
- Preparation of detailed Technology Transfer Packages (TTP)
Impurity Profiling
- Isolation & characterization of process-related impurities
- Fate of impurity studies & control strategy development