We provide technical expertise, guidance, mentorship, and training on all aspects of drug substance crystallization and drug product solid dispersion formulation, from laboratory R&D, pilot plant scale-up to commercial manufacturing including:
• Research and development in the areas of crystallization, purification, crystal form & physical property control for drug substance and solid dispersion formulation for drug product.
• Enhancement of knowledge and use of tools such as automated and advanced equipment, modeling, PAT, and perspectives on line of sight for commercial production.
• Enhanced understanding and training on fundamentals, industry-wide best practices, and perspective on emerging technologies.
• Guidance and assistance in optimizing the salt / crystal form / crystallization / formulation workflow among Drug Substance, Drug Product and Analytical Development. Propose opportunities and solutions for optimizing the drug substance and drug product interface between the final API crystallization and formulation.
• Assistance in the identification, assessment, prioritization, and implementation of external contacts and collaborations with key contract organizations, external specialists and/or academic institutions
• Guidance on general aspects of chemical engineering development in drug substance and drug product area, including reaction engineering, extraction, heat and mass transfer, mixing, blending, process safety, distillations, scale-up principles, quality by design, and modeling.
• Guidance includes recommendations on equipment selection, data collection and interpretation, and best practice development.
675 US Hwy One, Room 117
North Brunswick, NJ 08902