At Creative Biolabs, our Antibody Purity & Structural Integrity Assessment Services integrate advanced analytical platforms and expert data interpretation to deliver precise, high-resolution characterization. Our multi-tiered approach provides clients with detailed insights into antibody composition, structural integrity, isoform distribution, and aggregation profile, supporting reliable experimental results and informed decision-making.
Our services are structured into six focused subcategories, each addressing a critical aspect of antibody quality:
This service assesses antibody homogeneity and identifies contaminants, fragments, or degradation products. Key techniques include:
Antibody integrity reflects the preservation of molecular structure and functionality. This service employs complementary methods such as:
Determining amino acid composition provides insight into the primary structure and supports verification of antibody identity. Using hydrolysis followed by HPLC or LC-MS, we quantify individual amino acids, enabling detection of sequence inconsistencies, post-translational modifications, or production-related anomalies. This service is particularly valuable for engineered antibodies or novel constructs.
Isoforms and charge variants can arise from glycosylation, deamidation, or other post-translational modifications. We utilize ion-exchange chromatography (IEX), capillary isoelectric focusing (cIEF), and LC-MS to profile antibody isoforms, quantify charge heterogeneity, and identify minor variants. These assessments are crucial for understanding structural diversity and ensuring consistency across production batches.
Aggregation affects antibody stability, solubility, and biological activity. Our platform combines DLS, SEC-HPLC, analytical ultracentrifugation (AUC), and nanoparticle tracking analysis (NTA) to detect and quantify aggregates, measure particle size distribution, and evaluate aggregation propensity under stress or storage conditions. These data guide formulation optimization and long-term storage strategies.
Peptide mapping provides an in-depth, sequence-level characterization of antibodies. Using enzymatic digestion coupled with LC-MS/MS, we map peptide fragments to the expected sequence, verify modifications, and confirm disulfide bond formation. This service ensures that antibodies conform to design specifications and facilitates identification of sequence or structural deviations.
Our workflow is designed to ensure rigor, reproducibility, and actionable insights:
Clients should provide:
Combines electrophoresis, chromatography, mass spectrometry, and biophysical methods for a complete profile.
Detects minor impurities, aggregates, isoforms, and charge variants.
Flexible to accommodate monoclonal, polyclonal, fragments, and engineered antibodies.
Comprehensive reports with actionable insights for optimization and quality control.
Aggregation and structural analyses under stress conditions inform storage and handling strategies.
Full-length IgGs, Fab fragments, scFvs, bispecific antibodies, and other engineered constructs are all supported.
Yes. Ion-exchange chromatography and cIEF provide precise quantification of minor variants.
Yes. All clients receive detailed reports including raw chromatograms, electrophoresis gels, spectra, and analyzed data.
Yes. DLS, SEC-HPLC, and other biophysical assays allow assessment of aggregation propensity under thermal, pH, or mechanical stress conditions.
The ultimate value of an antibody lies in its biological function. We provide functional assays such as cell proliferation, cytotoxicity, neutralization, ADCC, and CDC to evaluate biological activity. These data are crucial for therapeutic antibody development and mechanism-of-action studies.
Learn More →Safety evaluation focuses on detecting potential contaminants and immunogenic risks. We measure endotoxin levels, host cell protein (HCP) residues, and nucleic acid contaminants, as well as monitor aggregation-related risks.
Learn More →Antibodies must remain stable under storage and handling conditions. We conduct forced degradation studies, thermal stability testing, freeze–thaw cycle analysis, and accelerated stability studies to establish optimal storage conditions and predict shelf-life.
Learn More →Our Antibody Purity & Structural Integrity Assessment Services provide a thorough, multi-dimensional evaluation framework, encompassing six specialized analyses that collectively ensure antibody quality, structural fidelity, and functional reliability. By integrating complementary analytical techniques with expert interpretation, we deliver comprehensive insights to support research, development, and laboratory optimization.
For research use only. Not intended for any clinical use.
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