Cell Culture and Downstream Processing Integration Using Proteinchip® Technology Application to Protein Analysis and Purification in Biopharmaceutical Manufacturing

Abstract

Ciphergen Biosystems has recently developed a novel technology called the ProteinChip® System that enables analysis of complex biological mixtures. The ProteinChip System employs a unique family of protein biochip arrays carrying functional groups (e.g. ion exchange, reverse phase, IMAC). These ProteinChip Arrays have been designed to bind proteins and peptides from complex biological mixtures such as fermentation or cell culture supernatants.

The technology is referred to as SELDI (Surface Enhanced Laser Desorption Ionization — Mass Spectrometry) which highlights the key elements of the technique: selective sample binding/desorption on functionalized surfaces followed by mass spectral analysis of retained components. This molecular weight-based analysis also reveals important information about protein integrity (e.g. proteolytic degradation, glycosylation) that can be exploited for the purpose of process optimization, lot acceptance criteria or product specifications.

Applications of Surface enhanced laser desorption ionization for protein expression analysis and fast purification optimization from cell culture and fermentation media are discussed in this paper.