mAb Characterization Services
Talk to Our Scientists
"*" indicates required fields
mAb Characterization services at CovalX
Full physicochemical characterization of a monoclonal antibody requires data from multiple complementary methods. Primary sequence, post-translational modifications, disulfide bond connectivity, glycan profile, intact molecular weight, conformational integrity, and aggregation state each address a distinct attribute of the molecule.
CovalX provides the complete set of MS-based characterization methods needed to build that package, run from a single CRO against the same sample. The services listed below correspond directly to the characterization attributes defined in ICH Q6B for biological products.
Need detailed characterization for your mAbs?
Our experts support you from R&D through submission.
Our services
Regulatory Context
ICH Q6B defines the physicochemical characterization program expected for biological products submitted to FDA, EMA, and other major regulatory agencies. The guidelines address primary structure, higher-order structure, PTMs, glycosylation, aggregation, and other product-related attributes.
Discuss your project with our scientists.
One CRO, Coordinated Data
Running mAb characterization across multiple vendors introduces variability in sample handling, documentation standards, and reporting formats. When the same molecule is analyzed for intact mass, PTMs, disulfide mapping, and conformational properties from a single sample submission, the results are directly comparable and can be consolidated into a single analytical package.
CovalX operates all methods in-house, with access to high-resolution LC-MS, High-Mass MALDI, nano-flow LC-MS/MS, and HDX-MS platforms. For programs that also require epitope mapping or de novo sequencing, these can be coordinated from the same sample, with combined reporting.