Host Cell Protein Assay (HCP)
Using genetically modified microorganisms and cell lines for biopharmaceutical manufacturing can introduce contamination by process-related impurities. One of the most important sources of contamination during product development and production of biopharmaceuticals is host cell proteins (HCPs) originating in the production cell line. HCPs are inherent to all production processes that rely on mammalian cell culture, bacteria or yeast and they can reduce drug efficacy and even delay or derail potential drug candidates after many years of development. To avoid immunological reactions and ensure patient safety, regulatory authorities demand that biopharmaceutical companies eliminate contaminants or reduce them to the lowest levels practical.
Measurement of host cell protein (HCP) contaminants is essential for developing and monitoring an effective purification process for recombinant and non-recombinant proteins. Of the multiple techniques available to quantify the concentrations of these contaminants, the most popular format uses polyclonal antisera in a sandwich ELISA.
BioScale has developed a Chinese Hamster Ovary (CHO) Host Cell Protein (HC) Detection Kit for use on its ViBE® BioAnalyzer or Workstation that specifically meets the needs of drug manufacturers that start upstream with Chinese Hamster Ovary cell lines and need to assess their downstream processes for HCP contamination.
Develop your own HCP Assay
The ViBE’s flexible nature and proprietary AMMP® detection technology, allows complete customization for notoriously difficult host cell protein assays. Assay development is as simple as porting existing immunoassays onto the system. The ViBE® Workstation also allows reagent addition steps to be timed and automated for hands-off testing.
See how BioScale can offer you significant advantages in workflow and hands-on time. To discuss your upstream and downstream bioprocess application needs, contact us.
ViBE® Workstation Versus Traditional ELISA in a Host Cell Protein (HCP) Assay
The performance of the ViBE® Protein Analysis Platform powered by the AMMP® (Acoustic Membrane MicroParticle) assay was evaluated when compared with a commercially available ELISA. An assortment of bioprocess samples was selected from multiple stages of the purification process to demonstrate these comparison results.
ViBE® Workstation performance was evaluated for inter- and intra-assay precision, quantitation range, and the ability to accurately measure the concentration of controls spiked into a sample. Both measurement techniques were able to accurately measure the concentrations of Chinese Hamster Ovary (CHO) HCP contaminants in 102 bioprocess samples. The results agreed well across the entire quantitation range, with a 3 ng/mL average difference between the two data sets. These data show that the ViBE® Workstation produces results comparable to established techniques and offers significant advantages with respect to work-flow and hands-on-time. To view or download this data as a poster presentation from BioProcess International or as an Application Note, please visit our Publications area of the website.
See how BioScale can offer you significant advantages in workflow and hands-on time. To discuss your upstream and downstream bioprocess application needs, contact us.
