We Also Provide Services LikeRead More
Process Research and Development
Process Research and Development
Our scientists and process engineers have a lot of expertise coming up with new, safe, efficient, and environmentally friendly ways to synthesise complicated compounds.
Route scouting, fit-for-purpose process development, process safety review, analytical technique development and validation, stability studies, and scale-up of therapeutic compounds for toxicity assessment and clinical trials are just a few of our competencies. Spike/purge studies, impurity identification, and in silico analysis to identify Potential Genotoxic Impurities (PGIs) in pharmacological compounds are all skills that the scientific team possesses. Mavens can also help clients build Salt Forms, Co-Crystals, and Solvates to improve stability and solubility, as well as polymorph screening and QbD-based process development for late-stage drugs. Both fee-for-service (FFS) and full-time equivalent (FTE) chemical services are available.
- To support various stages of Chemistry, Manufacturing, and Controls (CMC) services, the development team consists of professional and well-trained process scientists, analytical chemists, and chemical engineers who follow a regulatory-driven, phase-appropriate process development strategy.
- Fully functional synthesis laboratory, kilo-lab, and modern pilot-plant for quick scale-up of medicinal compounds for Preclinical/Tox Studies.
- Manufacturing suits for advanced intermediates and NCEs/APIs that are well-equipped, flexible, and adaptable.
- Manufacturing of drug compounds for clinical and commercial usage in a QP-audited cGMP plant and clean rooms.
Route Scotting and Process Development:
- Synthetic route design based on earlier work and the collective expertise of scientists.
- Routes are chosen and screened based on raw material availability, safety, economies, and resilience.
- Development and optimization of phase-appropriate processes
- Systematic approaches such as Design of Experiments (DoE)/Quality by Design are used to develop scalable procedures (QbD)
- Process optimization to identify key process parameters (CPP) and to comprehend the Proven Acceptable Range (PAR) and the Normal Acceptable Range (NAR) (NOR)
- Isolation, identification, characterization, and synthesis of impurities
Salt and Polymorph Screening:
- To construct a solubility curve and comprehend the Meta Stable Zone Width, a well-equipped crystallisation facility is required (MSZW).
- Studies of crystallisation to better understand polymorphism and stable forms.
- Experience with salt forms, Co-Crystals, and solvates to improve stability and solubility.
Expertise on Scales:
Mavens has a wealth of experience creating and scaling up processes employing the reagents listed below.
- Cyanation using NaCN, KCN, and CuCN
- Grignard Reactions
- Carbonylation using CO (Carbon Monoxide)
- by using NaBH4 / LiAlH4
- Friedel-Craft’s reaction
- Reduction
- 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
- Sulfonation using SO3H
- Fluorination (using electrophilic and nucleophilic fluorinating agents)
- Oxidation
- Alkylation and Acylation
- N-BuLi, sec-BuLi, and Dimethyl zinc
- Amination
- Diazotization
- Nitration
- Condensation
- Suzuki and Heck coupling
- Azidation
- Chiral resolutions
- Aminations (Reductive / Chiral)
- Cryogenic reactions