Successful completion of API process development is a tremendously challenging task, made even more difficult by the amount of analytical data collected. Furthermore, currently available batch tracking systems do not include any means to connect the batch family tree of a project with the analytical data collected for each batch. Batch information is typically handled in static Microsoft Excel worksheets, with all analytical data locked into various CDS and/or ELN platforms.

In response, new v2019.1 functionality in ACD/Labs Luminata, a CMC project decision support tool, now offers dynamic visualization of project analytical data through the process scheme and batch genealogy family tree.

Key Learning Objectives

Learn how Luminata can greatly boost your batch tracking analyses:

  1. Differentiate each experimental batch, and automatically arrange them into a comprehensive batch family tree.
  2. Perform inter-batch comparisons to clarify any differences in the presence and concentration of various reaction components.
  3. Investigate alternative catalysts and reagents for the same API endpoint through real-time access to the analytical data that supports batch genealogy frameworks.

Intended Audience

  • Process Development Teams
  • Chemistry, Manufacturing, and Controls (CMC) Specialists
  • Pharmaceutical/Medicinal Chemists