Discovery Process Chemistry
Sai Life Sciences’ Process Research team develops practical and scalable synthetic routes to enable efficient transition from discovery to development. The focus is on route selection, early process understanding, safety evaluation, and phase-appropriate optimization. Work is driven by mechanistic understanding, structured experimentation, and data-led decision making to ensure reproducibility, safety, and cost control. High-throughput experimentation (HTE) and green chemistry principles are applied where they add measurable value in route selection and early optimization.
What Defines Our Approach
- Development-Aware Route Design: Route selection considers overall program goals, such as downstream manufacturability, impurity control risk, raw material availability, and safety early in the program.
- Data-Rich Early Decision Making: HTE and parallel experimentation support rapid route feasibility and condition screening.
- Early Safety & Scalability Thinking: Preliminary thermal and reactivity risk understanding is built during feasibility stage.
- Integrated Transition to Development: Close collaboration with Process Development and Analytical teams reduces rework during scale-up.
Our Capabilities
Route Scouting & Selection
Goal-oriented design and evaluation of alternative synthetic routes based on SELECT principles.
Feasibility & Early Optimization
Screening of reagents, catalysts, solvents, and conditions to define reaction feasibility and early impurity understanding.
Early Kilo-Lab Enablement
Generation of non-GMP material and process understanding to support toxicology and early development needs.
Green & Sustainable Chemistry
Solvent selection, yield improvement, and waste reduction integrated into route and process design.
Phase-Appropriate Process Maturity
Development aligned to preclinical, clinical, and commercial stage expectations.
Technology Transfer to Development
Structured data packages and process documentation to support downstream teams.
Our Capabilities
Route Scouting & Selection
Goal-oriented design and evaluation of alternative synthetic routes based on SELECT principles.
Feasibility & Early Optimization
Screening of reagents, catalysts, solvents, and conditions to define reaction feasibility and early impurity understanding.
Early Kilo-Lab Enablement
Generation of non-GMP material and process understanding to support toxicology and early development needs.
Green & Sustainable Chemistry
Solvent selection, yield improvement, and waste reduction integrated into route and process design.
Phase-Appropriate Process Maturity
Development aligned to preclinical, clinical, and commercial stage expectations.
Technology Transfer to Development
Structured data packages and process documentation to support downstream teams.
Reaction Types
Sai Life Sciences supports a broad range of synthetic transformations during route scouting and feasibility evaluation, with focus on scalability potential and early process risk identification.
- Air/moisture sensitive chemistry
- Standard chemistry (alkylation, SNAr, amide formation, reductive amination, etc)
- Catalysis (Suzuki, Hartwig-Buchwald, etc)
- Asymmetric transformations
- Biocatalysis
- Visible-light photochemistry
- Salt screening/classical resolution
Facilities, Equipment & Technical Infrastructure
Our Process Research laboratories are equipped with high-throughput experimentation platforms for rapid condition screening, supported by reaction calorimetry and thermal screening tools for early safety understanding. In-process and offline analytical capabilities enable reaction monitoring and impurity tracking. Access to kilo-lab infrastructure supports early scale verification, while integrated digital ELN and QMS systems ensure traceable, compliant data capture.
Frequently Asked Questions
Sai Life Sciences approaches route scouting and selection by combining deep scientific expertise with a structured, collaborative process. The team begins by ideating multiple Routes of Synthesis (ROS) based on literature and internal brainstorming, then evaluates each for feasibility, cost, scalability, HSE compliance, IP status, and sustainability. Shortlisted routes are discussed with the client’s technical team, followed by fast-track proof-of-concept (POC) studies using parallel synthesizers. Once validated, the selected route undergoes phase-appropriate development to ensure successful scale-up and timely delivery for clinical trials.
Sai Life Sciences ensures scalability and robustness of chemical processes through a structured, collaborative approach involving process chemists, engineers, and analytical teams. The Technology Transfer and Process Design teams evaluate multiple synthesis routes, optimize unit operations, and conduct safety assessments to ensure plant readiness. Advanced tools like CFD simulations, Dynochem, and MixIT are used to refine mixing and reaction parameters. Continuous monitoring and iterative improvements ensure reproducibility, safety, and efficiency across clinical and commercial phases.
Sai Life Sciences has extensive experience handling complex APIs and intermediates, serving highly regulated markets like the US, Europe, and Japan. The manufacturing infrastructure is designed for flexible, small-volume, and challenging chemistries, including hydrogenation, cryogenics, lyophilization, and commercial chromatography. With over 25 years of expertise, they support late-phase and commercial programs, offering cGMP manufacturing and robust analytical development. The facilities have passed inspections by the US FDA and Japanese PMDA, and they routinely deliver high-quality outputs for New Chemical Entities (NCEs) across diverse therapeutic areas.
Yes, Sai Life Sciences supports kilo lab and pilot plant scale-up through phase-appropriate development services tailored for preclinical and clinical-stage NCEs. The facilities include 64L to 250L reactors in Hyderabad and a GMP kilo lab in Manchester with 35L vessels, filtration, and drying equipment. These setups mimic commercial-scale conditions, enabling rapid process familiarization and optimization. Integrated teams of chemists, engineers, and analysts ensure smooth tech transfer, scalability, and safety. This infrastructure accelerates timelines from lab to clinic while maintaining quality and regulatory compliance.