Our R&D and Product Management teams partnered with a division of Johnson & Johnson to write and submit a peer-reviewed paper to Analytical Chemistry.
Titled "Mobile Affinity Selection Chromatography Analysis of Therapeutic Monoclonal Antibodies," the paper explores why the 'Mobile Affinity Selection Chromatography (MASC)' that powers our Proteometer-L is a critical element of quality evaluation.
A full abstract along with a download link is posted below. We’re immensely thankful for our talented team who put months of hard work and research into this achievement!
“Federal regulatory agencies require continuous verification of recombinant therapeutic monoclonal antibody (mAb) quality that is commonly achieved in a two-step process. First, the host-cell proteome and metabolome are removed from the production medium by protein A affinity chromatography. Second, following recovery from the affinity column with an acidic wash, mAb quality is assessed in multiple ways by liquid chromatography–mass spectrometry (LC–MS).
However, lengthy sample preparation and the lack of higher-order structure analyses are limitations of this approach.
To address these issues, this report presents an integrated approach for the analysis of two critical quality attributes of mAbs, namely titer and relative aggregate content. Integration of sample preparation and molecular-recognition-based analyses were achieved in a single step utilizing an isocratically eluted mobile affinity selection chromatography (MASC) column.
MASC circumvents the protein A step, simplifying sample preparation. Within 10 min, (i) mAbs are fluorescently coded for specific detection, (ii) monomers and aggregates are resolved, (iii) the mAb titer is quantified, (iv) relative aggregate content is determined, (v) analytes are detected, and (vi) the column is ready for the next sample.
It is suggested herein that this mode of rapid quality assessment will be of value at all stages of discovery (screening, clone selection, characterization), process R&D, and manufacturing. Rapid monitoring of variant formation is a critical element of quality evaluation.”
The ‘canary in a coal mine’ symbolizes a sensitive alarm system portending health hazards. A simple, fast, low-cost, and single-column mobile affinity sorbent chromatography method for critical quality analysis of therapeutic monoclonal antibodies is described that circumvents multiple separation modes and sample preparation steps currently employed for flagging quality issues.