RJC Process Chemistry Consulting provides an extensive background and expertise in small molecule and siRNA oligonucleotide synthesis in process research. Skilled in rapidly discovering, developing and implementing new chemistry in a timely fashion to meet project requirements of API for pre-clinical through Phase III clinical studies.
RJC Process Chemistry Consulting helps you to develop concise, cost effective, safe and sustainable syntheses of complex target molecules utilized in the preparation of API, all while maximizing results and minimizing resources.
Experience and skill in both solving and avoiding scale-up issues, as well as discovering and implementing solutions to complex chemistry processes in laboratory, 100L, pilot plant and manufacturing operations.
Practiced in technical transfers to manufacturing division, CMOs and strategic partners, and CMC chemistry IND filing. Experienced with DoE, cGMP, QbD, and PAT.
Specialties
• Route selection
• Cost effective, sustainable synthesis design
• Reaction development and optimization
• Technical reports, analyses, and transfer to CMOs
• Pilot plant/manufacturing scale performance analysis, reaction trouble shooting, and implemention of solutions
• Performance Analysis and Design, cGMP design space, Critical Process Parameters (CPP), Design of Experiments (DoE), Quality by Design (QbD)
• Polymorph, solvate, hydrate, salt selection of API, as well as crystallization of key intermediates which impact on final API purity
