Overview
Pre-Conference Short Course
Day 1
Day 2
Day 3 
Register 
PDF Download 
Posters  
Hotel & Travel 
Sponsor 
Press Pass 
Request Brochure 


Stay on for the Second Annual
Drug Formulation
FRM Microbanner
November 19-20, 2008
Philadelphia, PA


codexis logo

Bio-IT World

Drug Discovery News

Drug Discovery Development

PharmCast

SelectScience logo

Science AAAS

The Scientist


Mastering Process Chemistry - Pre-Conference Short Course


Conference Proceeding CD Now Available
  • Speaker Presentations
  • Poster Abstracts
  • and More!

 

MONDAY, NOVEMBER 17


Pre-Conference Short Course: Demystifying Process Chemistry*

Neal G. Anderson, Ph.D., Anderson’s Process Solutions

7:30am Pre-Conference Short Course Registration and Morning Coffee

8:00 Start of Short Course
Currents of Green Chemistry Underlying Cost-Effective Process Development

Since green chemistry approaches can markedly decrease the cost of goods (COG), corporations are applying these approaches more often. 

  • Route selection can have the greenest impact, by reducing waste at source.
  • Selecting green solvents and catalytic reagents to minimize byproducts
  • Simplifying workups to minimize waste and optimize solvent recovery
  • Direct isolation guidelines
  • Process intensification.

Route Selection Goals
By designing a cost-effective route early in the development of a clinical candidate the cost of development may be markedly decreased in Phase 2 and perhaps earlier.

  • Identifying commercially available starting materials
  • Best location of convergent steps
  • Importance of crystalline intermediates
  • Exploiting enzymes for stereoselective processes
  • Recognizing opportunities for CIDR and CIAT processes

Optimizing Process Development by Minimizing Impurities
The quest to minimize and control impurities drives process development.

  • Developing appropriate in-process assays to monitor impurities preferentially
  • Setting suitable specifications
  • Anticipating impurities and byproducts
  • Recognizing opportunities for continuous operations
  • Removing metal salts from process streams
  • Anticipating and avoiding or minimizing genotoxins in the API
  • Preparing tox batches of suitably high impurity levels.

Developing Selective Crystallizations
Crystallizations offer opportunities to control processing to intermediates and APIs and physical characteristics of final form (salt, polymorph, solvate, particle size distribution), and are often under-utilized.

  • Considering the importance of water on final form
  • Designing crystallizations to dissolve impurities
  • Gradually applying crystallization pressure
  • Controlling isolation and physical characteristics of the crystals

Process Refinements
Often there is little time to refine a process before scale-up, but such considerations can avoid scale-up difficulties with relatively little additional effort.

  • Designing use-tests, abuse tests, and process tolerance tests
  • Using mass balances to assess processing unknowns
  • Simple guidelines for implementation: equipment cleaning, preferred charging sequence, Vmin & Vmax considerations, ability to transfer process streams, etc.
  • Optimizing within filed guidelines
  • Assessing the simplicity & ruggedness of processes

12:00pm Close of Pre-Conference Short Course

*  Separate Registration Required for Pre-Conference Short Course



By Series:
By Region:


Conference
& Course Catalog

CHI Catalog 


Short Course DVDs