Chemical Process R&D

AMRI’s chemical development team, comprised of over 150 scientists, practices a pragmatic culture in which scientists exceed expectations even on the most challenging projects. Working in state-of-the-art laboratories, equipped with the latest process and analytical instrumentation, AMRI scientists can efficiently conduct rapid process development, optimization of reaction conditions and scale-up of materials for preclinical trials or large-scale manufacturing.

Examples of AMRI’s services are:

• Custom Synthesis
• Process Safety Assessment
• Scale-up Capabilties
• Route evaluation and development of new synthetic routes for target molecules.
• Optimization of reaction conditions to reduce cost and maximize throughput by classical methods or statistical design of experiments (DOE).
• Development of reliable methods for in-process testing and analysis of intermediates and API’s.
• Scale-up of existing routes in jacketed glass reactors (50-200 L) and fixed reactors (up to 400 L capacity) to meet your API supply needs.
• Development of robust crystallization procedures for intermediates and final products.
• Salt selection and polymorph screening.
• Ability to perform work under cryogenic conditions (-78 °C) or high pressures (> 100 psi).
• Preparation of API’s for non-clinical safety studies (NCSS) under GLP conditions.
• Rapid screening of reactions conditions by utilizing parallel equipment (Mettler-Toledo MultiMax®, Radley’s carousels, Barnstead STEM RS-10, Radley’s Tornado system).
• Process safety assessment (multiple RC-1 calorimeters).
• Critical process parameter assessment.

With support from our expert team of analysts, chemical engineers and QA professionals, AMRI can rapidly and efficiently develop scalable manufacturing processes to meet any need, including highly potent compounds and controlled substances.