Rapid quantification of contaminants enables data-driven decisions throughout the biotherapeutics workflow, from cell line development and clone selection through to bioprocess development and production.

An open immunoassay platform ensures flexibility in assay specificity and format, for example, to determine host cell protein (HCP) contaminants from different cell lines or the presence of leached Protein A from affinity chromatography purification.

Save analyst time, increase lab productivity

		Multi-application platform producing high quality data
		Fast development - new assays can be running within days
		Fast assay turnaround - automated platform
		Fewer dilutions or repeats - broad dynamic range and reduced matrix effects
		Minimizes sample and reagent consumption

Transfer easily between labs or into regulated environments

		Template methods simplify outsourcing and assay transfer
		Regulatory support available, Gyrolab software 21 CFR Part 11 compliant

Data examples

Monitor HCP production during clone selection

Results demonstrate the efficiency of using a multi-application immunoassay platform. Different cell lines can be monitored for IgG and host cell protein production using the same immunoassay platform.

Multi-application platform producing high quality, reproducible data

Impurity testing (HCP), Host cell proteins, Monitoring, Contaminants, Activity binding assay, IgG, AstraZeneca

Data courtesy of Astra Zeneca

Comparison with established ELISA HCP format

Medimmune compared their established ELISA process with that of the process used on their Gyrolab workstation. Their findings demonstrated significant savings in labor and time, including a significantly higher ‘first run’ success rate, thereby improving productivity. In addition, sample and reagent consumption were lowered and dynamic range increased.

Improved productivity

Impurity testing (HCP), Host cell proteins, Monitoring, Contaminants, Activity binding assay, MedImmune, ELISA

Correlation with established ELISA - increased dynamic range

Data courtesy of E. Bishop, Medimmune, Gaithersburg, USA. Results presented at BPI 2009.

Monitor HCP production during optimization of cell culture conditions

This work determined the effect of parameters such as temperature and media on the production of HCP contaminants as well as target IgG.

Efficient use of a multi-application platform

Product quantification (lgG titer), Expression, Cell line development, Clone selection, Monitoring, GE Healthcare, HCP

High reproducibility

Impurity testing (HCP), Host cell proteins, Production, Monitoring, Contaminants, Activity binding assay, IgG, GE Healthcare

Data courtesy of GE Healthcare

High sensitivity quantification of CHO HCPs during bioprocess development

The assay was needed to determine the presence of HCPs in products manufactured by recombinant expression in Chinese hamster ovary cells. A Gyrolab Bioaffy 200 CD was chosen to achieve high sensitivity. Using a Bioaffy 20HC CD could increase the upper limit of quantification by a factor of 50 if required.
The assay was successfully transferred from an ELISA format (Cygnus Technologies Inc).