An assay for measurement of protein adsorption to glass vials

PDA J Pharm Sci Technol. 2010 Jul-Aug;64(4):305-15.

Abstract

Protein adsorption to primary packaging is one of the problems faced by biopharmaceutical drug companies. An assay was developed to quantify loss of proteins to glass vial surfaces. The assay involves the labeling of protein with a fluorescent dye, incubation of the labeled protein with the vial surface, elution of the adsorbed protein using a stripping buffer, and determination of fluorescence of the adsorbed protein using a fluorometer. The assay is simple to set up, accurate, sensitive, and flexible. The assay can be modified for indirect measurement of protein adsorption and offers an attractive alternative for researchers to quantify protein adsorption to glass vials and syringes.

MeSH terms

  • Adsorption
  • Biological Assay
  • Drug Packaging*
  • Drug Storage
  • Fluorescent Dyes
  • Glass
  • Proteins*
  • Syringes

Substances

  • Fluorescent Dyes
  • Proteins