Process familiarisation, optimisation & development
Phase-appropriate process development to ensure successful scale-up and timely product delivery for your clinical trials
The teams at Sai Life Science are extremely conscious of developing clinical phase appropriate, yet compliant and robust processes to expedite your drug development program.
- Significant experience in handling wide range of chemistries, sensitive reagents / catalysts and category compounds
- On-site technology platforms, for complementing process development
- Modern infrastructure, tools and techniques for efficient process development
- Constant collaboration with process engineers for successful scale-up
Our Process R&D team has significant experience in developing and scaling up multi-step processes for complex heterocycles, carbohydrates, nucleosides and nucleotides, organometallic compound, Vit D analogues, peptides as well as prostaglandins, to name few. We have successfully developed and commercialised several asymmetric synthesis, Suzuki, Sonagashira, Kumada and Heck coupling, turbo Grignard, classical halogenations, carbonylation, Ozonolysis, Buchwald amination, chiral reduction, among others.
We have internally developed standard procedures for efficiently handling sensitive reagents and catalysts.
The team members are well-versed with all process development aspects like route scouting, alternate reagents and catalysts screening, solvent selection, Impurity profiling with control strategy, NoR and PaR studies, DoE / QbD, plant simulation studies, Identification of CPP – CPA and controls to ensure operational feasibility, Cost competitiveness and sustainability. Experiments are carried out in our modern laboratories equipped with parallel synthesisers, catalyst screening autoclaves, double-jacked flask with fully-automated and controlled utilities and data acquisition software.
Simultaneously dedicated team of experts explores our technology platforms like Flow Reactors, Crystallisation control set ups, bio catalysis, chemo catalysis, ATFE, Short path distillation, LLE, photochemical reactors and Lyophilisation, to augment the mainstream process development.