Further, SynSmart’s sourcing team works on identifying starting material from global sources while focusing on risk-mitigation via diversification while keeping costs and timelines in control.
SynSmart offers process research and services to help partners accelerate the scale-up of their candidates/intermediate to bridge the gap between research and commercialization. Our process research team works expeditiously to reduce time and costs of synthesis in a structured way by identifying areas of high impact and striking a balance on time and cost.
Typically, potential candidate compounds from the Discovery Stage of research are produced in gram quantities. Initial processes can be scaled to produce materials up to hundreds of grams. Scaling to a kilogram or larger scale can require substantial process modifications, and until that step occurs; the economics, product consistency and quality are uncertain.
Our team is able to carry out process and scale-up chemistry, and help you with a smooth transition from discovery to pre-clinical development, and subsequent Non-GMP manufacturing.
Route scouting and development
Designing of synthetic routes based on prior art and combined wisdom of scientists. Selection and Screening of routes based on ease of availability of raw materials, safety, economics and robustness.
Process optimization and scale up
Developing scalable manufacturing processes using systematic methodologies such as Design of Experiments (DoE)/Quality by Design (QbD). Process optimization to identify critical process parameters (CPP) and to understand Proven acceptable Range (PAR) and Normal Acceptable Range (NOR)
Analytical methods and quality control
Developing analytical methods and quality control procedures, Preparing technology transfer packages
Reference Standard/Impurities
Impurity characterization and management. Reference standard preparation and characterization
Our expertise in developing and scaling up processes involve below reactions
- Grignard Reactions
- Reduction by using NaBH4 / LiAlH4
- Friedel-Craft’s reaction
- Chlorination (using SOCl2, POCl3, HCl, Cl2)
- Bromination (using bromine/HBr in acetic acid)
- High pressure hydrogenation reactions (using Pd/C, Pt/C, and Raney Ni up to 15 bar)
- High temperature reactions up to 200 ⁰C
- Nitration
- Sulfonation using SO3H
- Chiral resolutions
- Alkylation and Acylation
- N-BuLi, sec-BuLi, and Dimethyl zinc
- Amination
- Condensation
- Oxidation
- Suzuki and Heck coupling
- Diazotization
- Azidation
- Aminations (Reductive / Chiral)
- Cyanation using NaCN, KCN, and CuCN