Process Development Seminar in San Diego
Regis Technologies invites you for a seminar on "Avoiding Potholes in Process Development" delivered by guest speaker Neal G. Anderson, PhD, author of Practical Process Research & Development. Read the abstract below for more details. A light breakfast will be served.
Join us for coffee and chemistry on Thursday, June 11th, 8-9:30AM.
Coffee served at 8:00am; presentation begins at 8:30am; Q&A at 9:30am.
Avoiding Potholes in Process Development
Neal G. Anderson, PhD
author of Practical Process Research & Development
The first questions that a scale-up organization asks are: How much material is needed? How soon? For what purpose?
All processes are developed to be fit-for-purpose, with different requirements at different stages of development. Safe operating conditions must be identified for effective scale-up; perhaps continuous flow chemistry offers advantages, or the chemistry could be outsourced to CROs that specialize in handling energetic chemistry. Mass transfer, heat transfer, and extended operating times can impact scale-up. Workups must be designed to thoroughly quench reagents and ideally deliver the product without decomposition. For early Phase studies products can be purified by chromatography, later perhaps by extraction and crystallization. The stability of intermediates can pose problems. Thorough analytical investigations are justified to unambiguously identify compounds. Screening for the optimal final form should be carried out early, unless the product is an oil or a lyophile. Structurally related impurities, potentially mutagenic impurities, and residual elemental metals must be controlled. As a compound progresses towards commercialization processes are developed to be more cost-effective.
This talk will discuss examples in the above areas, and how to anticipate and avoid problems in process development.
Neal G. Anderson, PhD
For the past 17 years Neal has consulted to the pharmaceutical and fine chemical industries on chemical process research and development. He has presented short courses internationally on process R&D for "small molecules" to over 1400 participants from more than 160 companies. Keys to efficient scale-up are anticipating and then avoiding diffiulcties. Prior to consulting he worked at Bristol-Myers Squibb for 17 years. During that time, he had extensive hands-on experience with chemical process R&D in the lab, pilot plant, and manufacturing sites, including 12 manufacturing start-ups and process development for four major drugs. He is the author of Practical Process Research & Development (Academic Press; 2nd edition 2012).
Education & Training
- 1977-1979, post-doctoral studies, McNeil Laboratories
- 1977, Ph.D., Medicinal Chemistry, University of Michigan
- 1972, B.Sc., Honors Biology, University of Illinois