Skills & Services

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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 (CapotenĀ®) process that I originated.
  • 34 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

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