Scientific Publication - PERSPECTIVES, An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics
AUTHORS
Deepak K. Sharma, Dave King, Peter Oma, Clark Merchant
Published Online at Springerlink DOI: 10.1208/s12248-010-9205-1
ABSTRACT
The need to monitor, measure, and control sub-visible proteinaceous particulates in biopharmaceutical formulations has been emphasized in recent publications and commentaries. Some of these particulates can be highly transparent, fragile, and unstable. In addition, for much of the size range of concern, no practical measurement method with adequate sensitivity and repeatability has been available. A complication in measuring protein particulates in many formulations is the simultaneous presence of other particle types such as silicone micro-droplets, air bubbles, and extrinsic contaminants. The need has therefore been identified for new analytical methods which can accurately measure and characterize sub-visible particulates in formulations. Micro-flow imaging has been shown to provide high sensitivity in detecting and imaging transparent protein particles and a unique capability to independently analyze such populations even when other particle types are present.
KEY WORDS: light obscuration; micro-flow imaging; particle sizing; protein aggregation; protein formulation.
The complete article can be found at:
http://www.springerlink.com/content/a12w05k58362482g/
Application Note - Dilution Series Measurements on Protein Formulations with MFI
OVERVIEW:
Characterization of sub-visible particle populations in protein formulations is a regulatory requirement during formulation development. Analytical method development and validation recommends the use of linearity studies to help determine the suitability of a particular analytical technique. Many protein formulations are highly sensitive to dilution and sample preparation techniques, and therefore may produce an inherently nonlinear subvisible particle population. The purpose of this application note is to illustrate this effect using a particle counting system (Micro-Flow Imaging).
The complete article can be found on our website: Click Here for Application Note
Further data on this subject was recently presented at the 2010 AAPS National Biotechnology conference. Please contact me directly for a copy of the poster.
REQUEST POSTER on Dilution Series Experiments
