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Monoclonal Antibody Characterization

Monoclonal Antibody Analysis

Monoclonal antibody (mAb) therapies are the fastest-expanding class of protein therapeutics and a major emphasis for biopharmaceutical companies. The basic concept involves cloning targeted monoclonal antibodies from immune cells, unlocking an army of high-affinity molecules that can bind vital antigens on everything from pathogens to cancer cells. For drug developers, this presents significant potential but also significant risk. Immunogenicity is an ongoing challenge and in recent years, competition has gotten tighter with the introduction of biosimilars. Companies must actively push for the very best in safety and efficacy to build a therapeutic franchise that can last.

Avomeen has the instruments, methods, and expertise necessary to excel in monoclonal antibody characterization and analysis. We’re always thinking one step ahead, advising clients and performing a range of vital analytical tests to ensure top safety, reproducibility, and yield before large-scale biomanufacturing begins. Along with the data, our team can help guide a steady, efficient path through regulatory approval.

Avomeen brings:

Optimized method development and validation, for long-term manufacturing efficiency. Guidance on the data and documentation needed to meet regulatory requirements the first time around. Skilled tech transfer capabilities, smoothing the transition as you prepare to manufacture at scale.

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Monoclonal Antibody Characterization Capabilities:

We work with our partners to understand their specific needs, drawing on a range of analytical methods and equipment. This may include:

Services:

  • Concentration/yield determination
  • Purity assessment
  • Protein identification services
  • Forced degradation studies
  • Cellular potency and efficacy
  • Glycosylation determination
  • Post-translational modification determination
  • Host cell protein impurity detection
  • Trace metal analysis
  • Process impurity detection
  • Cell culture media validation

Instruments:

  • Capillary electrophoresis (CE, Protein Simple Maurice)
  • Ultra-performance liquid chromatography (UPLC, Agilent) with UV-DAD and FLD
  • High-performance liquid chromatography (HPLC, Agilent) with UV-DAD, Sedex, Varian, ELSD
  • Dionex ICS-3000 Ion Chromatography System
  • Seivers Total Organic Carbon Analyzer
  • Agilent 7500ce ICP-MS
  • AB Sciex Triple Quadrupole API 2000 and 3000 Mass Spectrometers
  • Waters Acquity UPLC with Xevo G2-S Quadrupole Time of Flight (QTOF)
  • Mammalian cell culture facility
  • Caron stability chambers (custom settings)
  • Metrohm 899KF Karl Fisher Coulometer
  • Perkin-Elmer Spectrum 65 and Spectrum 100 Fourier Transform Infrared Spectrometers (FTIR)
  • Perkin Elmer Lambda 365 UV/Vis Spectrophotometer
  • Fluorescent & UV plate readers

Looking for other drug development services? Check out our extractables & leachables and formulations services.

Technical Advances in Monoclonal Antibody Specificity and Sensitivity Testing

The foundational technology behind monoclonal antibodies, hybridoma generation, was first described in 1975. Since then, the global therapeutic antibody market has ballooned, with an estimated annual revenue of more the billion. This is expected to double within the next decade, in part due to the addition of new technologies such as phage display.

With this increased competition, research teams need to think proactively about the scalability of their process methods, while navigating the longstanding analytical challenges. Monoclonal antibody discovery and development suffers from the same issues as other protein therapeutics, with the added challenge of having to screen multitudes of clonal variants for specificity.

Here, Avomeen is a dynamic partner. We understand the impact of solubility, stability, and distribution in monoclonal antibody development. Likewise, we know the process and work to generate the data you need efficiently and effectively. We apply proactive QC-minded thinking to pre-empt manufacturing challenges, while maintaining a holistic view of cell productivity and critical quality attributes. Even with the additional complexities brought on by antibody humanization and glycosylation, we help companies advance steadily towards their commercial goals.

 

How can we help advance your antibody pipeline?
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