Explore the high-throughput pilot studies, rigorous stress-test data, and peer-reviewed research demonstrating that the RaPiD-mAb-MS™ platform delivers complete sequence coverage and high-quality peptide mapping in ~ 1 minute.
Industry Validation
A Head-to-Head Comparison on 275 mAbs
To prove our platform meets the rigorous analytical standards of top-tier biopharma, we partnered with a global top 5 pharmaceutical company to process a 275-sample forced-degradation cohort in a direct, head-to-head comparison against their standard workflow.
The Legacy Baseline:
Using an accelerated 40-minute LC-MS method, analyzing this cohort monopolized a mass spectrometer for 8 full days, not including sample preparation or analysis time.
The RaPiD-mAb-MS™ Reality:
Using our automated 96-well preparation kits and ~1-minute direct infusion method, the entire 275 mAb cohort was prepared, collected, and processed in just 12 hours.
The Result:
The RaPiD-mAb-MS™ platform delivered comprehensive molecular characterization and quantification that correlated perfectly with the company’s 8-day LC-MS results, proving you can eliminate the chromatography column without sacrificing data quality.
Proven at Scale
1,152-Sample Robustness Matrix
To demonstrate the scalability of the platform, we partnered with another global top 5 pharmaceutical company to execute a 1,152-sample high-throughput experiment analyzing four distinct monoclonal antibodies (NIST mAb, belimumab, nivolumab, and MAB1). We subjected these antibodies to a matrix of real-world pharmaceutical formulations and stressors, including:
Excipients:
Arginine, sodium chloride, proline, sorbitol, and sucrose.
Common Buffers:
Citrate, acetate, histidine, and Tris.
Surfactants:
Notorious MS-interfering agents like polysorbates (Tween 20 and 80).
Chemical Stressors:
Peroxide, methionine, iron, and EDTA.
The Result:
The automated 96-well workflow easily scaled to analyze the entire 1,152-sample set in just 35.5 hours of MS time. The platform provided exceptional, uniform data quality regardless of the formulation. Across the 1,152-sample matrix, the platform afforded a median sequence coverage of 100% for belimumab, nivolumab, and MAB1, and a 96% median coverage for the NIST standard.
Peer-Reviewed Innovation
The foundational technology behind CeleramAb was developed at the University of Wisconsin-Madison and rigorously validated in partnership with leading pharmaceutical scientists from AbbVie, Eli Lilly, Genentech, and Johnson & Johnson.
Read the Pre-Print Manuscript: Rapid Peptide Mapping of Monoclonal Antibodies with Direct Infusion Mass Spectrometry.
Massive Scale: Extensive proof-of-concept data spanning 28 unique therapeutic antibodies and over 2,000 successfully processed samples.
50X Acceleration: Detailed methodology demonstrating the elimination of chromatography to analyze 96 samples in under 2 hours (~1,000 peptide maps per day).
Uncompromised Quality: Direct comparisons to legacy LC-MS demonstrating consistent 100% sequence coverage and accurate quantification of critical quality attributes (oxidation, deamidation, isomerization, and glycosylation).
