Key Elements of an Effective Testing Program to Identify Extractables and Leachables
May 30, 2013
By BioPharm International Editors
Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Ferdinand Dabu, director of marketing at SGS live at Interphex 2013 about extractables and leachables. In this interview they discuss the key elements of an effective testing program to identify extractables from materials and leachables in drug products.
In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.