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, February 26th, 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.