Antibody Drug Evaluation & Testing
A complete analytical package from primary to higher-order structure — concentration, purity, charge heterogeneity, post-translational modification, aggregates and fragments, bioactivity and residual impurities.
Antibodies and other large-molecule biologics are structurally complex: their activity, safety and stability hinge on precise molecular structure and are affected by post-translational modification and process-related impurities.
SanjingBio's characterisation service analyses and controls the critical quality attributes (CQAs) — structure, purity, activity and impurities — in depth, supplying reliable data and quality assurance from early research through process development so a candidate meets both expectations and regulatory requirements.
High-precision mass spectrometry and chromatography provide full QC analysis of antibody structure, purity, charge heterogeneity and more.
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The platform analyses everything from primary to higher-order structure — concentration, purity, charge heterogeneity, post-translational modification, aggregates and fragments, bioactivity and residual impurities.
Standard operating procedures and a quality management system built on Chinese and international pharmacopoeias and industry guidance keep methods accurate, reproducible and traceable, with compliant, reliable data.
Equipment includes HPLC/UPLC, capillary electrophoresis, mass spectrometry, circular dichroism and differential scanning calorimetry, safeguarding sensitivity and precision.
The technical team combines deep expertise with hands-on experience across hundreds of drug development projects, responding quickly with precise characterization strategies for monoclonals, bispecifics, fusion proteins and more.
Five stages, with the panel tailored to project stage — early programmes usually cover purity and structural confirmation, while process development adds charge variants, glycosylation and stability.
Characterisation dimensions and methods are set by molecule type and project stage
Samples are received, checked and registered into the controlled workflow
HPLC/UPLC, CE, MS, CD and DSC platforms run to SOP
Data from every dimension is consolidated and interpreted against the development stage
A compliant, traceable analytical report with all raw data
Coverage spans four classes — purity and impurities, structural confirmation and post-translational modification, biological activity, and higher-order structure — combined to suit the project stage.
Standard operating procedures and a quality system built on Chinese and international pharmacopoeia and industry guidance keep methods accurate, reproducible and traceable, with data fit for regulatory use — running on HPLC/UPLC, capillary electrophoresis (CE), mass spectrometry (MS), circular dichroism (CD) and differential scanning calorimetry (DSC).
Share the intended application and what you already have in hand. A scientist — not a sales rep — will scope feasibility, suggest the right route and send a quote, usually within one business day.
