Scientists at Micromet AG, Munich have used Biacore technology to help them rapidly establish a validated assay according to current ICH guidelines
Biacore International AB has announced the availability of a new application notedetailing the use of surface plasmon resonance (SPR) technology for determining the concentration of monoclonal antibodies (Mabs), under production for the treatment of prostate cancer.
Scientists at Micromet AG, Munich have used Biacore technology to help them rapidly establish a validated assay according to current ICH guidelines.
Biacore was selected as the instrument of choice for monitoring Mab concentration across the production process, since the quality of principal assay parameters can be easily and rapidly validated.
Within just three months, the highly robust assay was constructed according to the ICH Guidelines, and was designed to determine the concentration of MT201 - a monoclonal, fully human anti-EpCAM IgG1 antibody in solution.
Protein A was immobilized on certified Sensor Chip CM5 to serve as the IgG-specific binding molecule.
Ligand immobilisation conditions were optimized and a concentration range of Mab MT201 was passed over each flow cell, with Protein A-MT201 binding levels measured.
Once the ligand immobilization conditions were optimized, focus turned to other critical assay validation parameters and experimental design.
The influence of assay components, such as, surfactant, Protein A and buffer composition, upon concentration measurements were determined in order to achieve an optimal assay.
Such rigorous optimization of the Biacore assay allows Micromet to establish an accurate assay for Mab concentration measurements in GMP-regulated laboratories. Biacore's system also gave both lower standard deviations and variances in the data, in a single, direct comparison with identical samples between Biacore and ELISA.
According to Fredrik Sundberg, Marketing Manager, Drug Development, QC and Validation, Biacore International SA, "As demonstrated by Micromet's work, Biacore lends itself to speedy qualification for use in concentration measurement applications in GMP-regulated laboratories.
This is just one of a number of examples of Biacore's broad application in the GMP environment." Biacore is designed for rapid concentration analysis of protein-based therapeutics in drug development, in-process control applications and manufacturing quality control (QC).
Biacore is the first system based on SPR for QC applications designed specifically for compliance with current GxP (GLP, GCP, GMP) requirements and 21 CFR Part 11.
Copies of the application note entitled: "Rapid development of a GMP-compliant Biacore assay for the determination of antibody concentration" are available on request.
