- Route Scouting, Fit for purpose Process development and optimization, Process safety studies, Analytical method development and validation, stability studies, scale-up of drug substance for Tox and clinical studies
- Well-equipped, QP-audited cGMP Kilo lab, pilot plant and commercial production plant
- An excellent scientific team of skilled, well-trained and highly experienced synthetic organic chemists, analytical chemists, and chemical engineers to follow a regulatory-driven, phase-appropriate process development strategy to support various stages of Chemistry, Manufacturing & Control (CMC)
- Experienced scientists with deep understanding of drug discovery and development to ensure speedy and flawless execution of CMC campaigns in a cost-effective manner
Chemistry Services Include:
- Gram to multi hundred kilo gram scale synthesis (non-GMP & cGMP)
- Focused libraries, Scaffolds, building blocks and Intermediates
- Reference and standard compounds
- Metabolite and impurity synthesis
- Stable label compounds (deuterium labelled)
- Scale-up support to DMPK and Tox studies
Route Scouting and Process Development:
- Design and demonstration of innovative and robust synthetic routes
- Phase appropriate process development and optimization
- Impurity isolation, identification and synthesis
- Design and development of scalable, robust, safe and cost-effective processes using systematic methodologies such as Design of Experiments (DoE) and Quality by Design (QbD)
- Process optimization to identify critical process parameters (CPP) and to obtain optimum yields and high quality of products
- Process validation studies to assure products meet specified quality parameters consistently and reliably
Process Hazard Analysis/Process Safety Assessment:
- Identification of potential hazards such as uncontrollable exothermic reactions, explosive reactions, unexpected release of toxic or flammable gases etc., by performing careful Process Hazard Analysis/Process Safety Assessment to eliminate unsafe operations
- Process Safety Assessment using Reaction Calorimetry (RC) and Differential Scanning Calorimetry (DSC)
Tech-Transfer and Scale-Up:
- Modern equipment, utilities, and state-of-the-art scale-up capabilities to supply drug substance for Tox, clinical studies and commercial use
- Seamless technology transfer from lab to pilot-plant and to commercial plant for large-scale manufacturing
Polymorph, Salt and Hydrate Screening:
- Polymorph screening, identification and evaluation
- Comprehensive salt, hydrate or co-crystal screening studies
- Synthesis of metabolites and their characterization using LC-MS/ MS and NMR spectroscopy
