Element’s phase-appropriate antibody characterization and analytics services are tailor-made to meet your needs throughout the biopharmaceutical product lifecycle, from discovery to post-market surveillance.
Our consultative team can help guide drug developers through a steady, efficient path to regulatory approval, employing a range of essential analytical tests to ensure safety, reproducibility, and yield prior to large-scale biomanufacturing.
With a proactive quality control mindset, our biopharmaceutical scientists maintain a holistic view of cell productivity and critical quality attributes (CQAs), ensuring long-term manufacturing efficiency. Our purpose-built labs host a wide range of instrumentation to support antibody analysis and antibody characterization, including capillary electrophoresis, a mammalian cell culture facility, stability chambers with custom settings, fluorescent and UV plate readers, and a mass spectrometry and chromatography, including QExactive and Quadrupole Time of Flight (QTOF) systems.
Monoclonal antibody characterization services
- Assessment of purity
- Cellular potency and efficacy
- Concentration/yield determination
- Determination of glycosylation
- Forced degradation studies
- Impurity detection (host cell proteins, process impurities)
- Post-translational modification determination
- Protein identification
- Trace metal analysis
- Validation of cell culture media
The Element advantage
Element offers comprehensive GMP services at every development stage for large molecule therapies, and we understand the unique challenges that monoclonal antibody therapies present, including the need to screen multitudes of clonal variants for specificity. Leading biopharmaceutical developers trust Element to provide a robust analytical package that addresses monoclonal antibody specificity in addition to keeping CQAs at the forefront of phase-appropriate antibody analysis.
For more information about Element’s monoclonal antibody (mAb) characterization and analysis services or to request a quote, contact us today.
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