NEAL G. ANDERSON, Ph.D. Consultant

PROCESS RESEARCH AND DEVELOPMENT SKILLS AND SERVICES

• Advising pharmaceutical and fine chemical industries on developing and troubleshooting processes for large-scale preparation of drug substances and intermediates
• Helping guide the process R & D efforts of Contract Research Organizations and Contract Manufacturing Organizations
• Assisting in preparing the API / CMC portion of regulatory filings, focusing on process descriptions, specifications, and impurities such as genotoxins
• Assisting in technology transfer to manufacturing sites
• Advising on equipment selection for scale-up laboratories
• Presenting short courses publicly and in-house on developing practical scale-up processes for “small molecules”

UNIQUE QUALITIES

• Author of Practical Process Research & Development (2nd edition, 2012; 1st edition, 2000; Academic Press)
• Developed and introduced processes for the manufacture of four major drugs and intermediates for E. R. Squibb / Bristol-Myers Squibb
• Proven success in developing practical, cost-effective processes. Example: Savings of about $3.7 M annually through the implementation of the simplified captopril (Capoten®) process that I originated.
• 40 years of experience in developing processes for practical scale-up
• Courses on process R & D presented internationally to more than 1400 participants from more than 160 companies
• Co-chair for the  2016 Organic Reactions & Processes Gordon Research Conference.