New quality control method for monitoring biopharmaceutical product
A novel technique for monitoring biopharmaceutical product quality was recently put to the test by NIST and 28 labs representing the biopharma industry, tool and software vendors, and the federal government. The outcomes of this interlaboratory study were recently released in the Journal of the ASMS.
The novel multi-attribute method, or MAM, is an arising, mass spectrometry-based method for monitoring product quality and identifying various types of potential contaminants in biopharmaceutical products with a single-step analysis.
Participators assessed MAM utilizing the NIST Monoclonal Antibody (NISTmAb) Reference Product 8671 as a model test sample. They were offered numerous modified NISTmAb samples and requested to report any differences seen between those and the unaltered referral material.
The research revealed that participating laboratories successfully identified numerous sorts of modifications in the samples utilizing MAM, like impurities and chemical transformations that have to be snugly constrained when manufacturing biopharmaceutical products.
Additionally, the research identified the current abilities and difficulties related to the multi-attribute method and describes the finest practices that can enhance reliability.
Trina Mouchahoir, research chemist, NIST, stated that the utmost aim is to expedite the time-to-market for life-saving medications via more efficient quality control techniques, and this research offers a roadmap for getting there.
The Multi-Attribute Method Consortium was originally established as a venue to harmonize best practices, share experiences, and also create ingenious methods to help with the prevalent assimilation of the MAM system, which is an arising use of ultra-high-performance liquid chromatography-mass spectrometry.
Successful application of MAM as a purity-indicating assay needs new peak detection (NPD) of the potential procedure – and/or product-related contaminations. The NPD interlaboratory research outlined here was conducted by the Multi-Attribute Method Consortium to report on the industry-wide performance of new peak detection utilizing predigested samples of the NIST Monoclonal Antibody Reference Material 8671.
New biopharmaceutical quality control method for monitoring biopharmaceutical product