Our Scientists and Process Engineers have vast experience in developing novel, safe, efficient, and environmentally friendly routes for the synthesis of complex molecules.
Our capabilities include route scouting, fit-for-purpose process development, process safety evaluation, analytical method development and validation, stability studies and scale-up of drug substances for toxicity assessment and clinical studies. The scientific team is well versed with spike/purge studies, impurity identification, in silico analysis to assess Potential Genotoxic Impurities (PGIs) in drug substances. Eurofins Advinus can also support clients in developing Salt Forms, Co-Crystals and Solvates to enhance Stability/Solubility, polymorph screening and QbD based process development for late phase compounds. The chemistry services are offered in both Fee-For-Service (FFS) and Full-Time Equivalent (FTE) basis.
- Development team consists of skilled and well-trained process scientists, analytical chemists and chemical engineers to follow a regulatory-driven, phase-appropriate process development strategy to support various stages of Chemistry, Manufacturing, & Controls (CMC) services.
- Fully functional synthesis laboratories equipped with sophisticated instruments, kilo-lab and modern pilot-plant for rapid scale of drug substances for Preclinical/Tox Studies.
- Well-equipped, flexible & adaptive manufacturing suits for advanced intermediates and NCEs/APIs.
- QP-audited cGMP plant and clean-rooms for manufacturing of drug substances for clinical and commercial use.
- 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.
- Phase appropriate process development and optimization
- Development of scalable 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)
- Impurity isolation, identification, characterization, and synthesis
- Well-equipped crystallization lab to generate solubility curve and understand the Meta Stable Zone Width (MSZW)
- Crystallization Studies to understand the Polymorphism and Stable form
- Experience in developing salt forms, Co-Crystals and solvates to enhance stability/solubility
Eurofins Advinus has excellent expertise in developing and scaling up processes involving below reagents
- Cyanation using NaCN, KCN, and CuCN
- Carbonylation using CO (Carbon Monoxide)
- Grignard Reactions
- Reduction by using NaBH4 / LiAlH4
- Friedel-Craft’s reaction
- Chlorination (using SOCl2, POCl3, HCl, Cl2)
- Bromination (using bromine/HBr in acetic acid)
- Fluorination (using electrophilic and nucleophilic fluorinating agents)
- 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
- Alkylation and Acylation
- N-BuLi, sec-BuLi, and Dimethyl zinc
- Amination
- Condensation
- Oxidation
- Suzuki and Heck coupling
- Diazotization
- Azidation
- Aminations (Reductive / Chiral)
- Cryogenic reactions
- Chiral resolutions