Element’s industry-leading expertise, methods, and purpose-built laboratories help to guide a steady, efficient path through regulatory approval for monoclonal antibody (mAb) therapies, the fastest-expanding class of protein therapeutics.
To build a lasting therapeutic franchise, leading healthcare brands must actively push for the very best in safety and efficacy while bringing therapies to patients as quickly as possible. Monoclonal antibody therapies have significant potential, but they also present significant risks, reinforcing the need for a partnership with trusted a CDMO that excels in monoclonal antibody characterization and analysis.
When targeted monoclonal antibodies are cloned from immune cells, a mass of high-affinity molecules are released that can bind vital antigens to everything from cancer cells to pathogens. However, immunogenicity is an ongoing challenge, and competition in the market is growing with the introduction of biosimilars. At Element, we’re always one step ahead, exceling in QC-minded monoclonal antibody characterization and analysis. We offer a range of critical analytical tests to ensure the highest safety, reproducibility, and yield prior to large-scale biomanufacturing. As a true partner, we advise and work alongside clients to develop a robust data package and efficient regulatory submission strategy.
Monoclonal antibody characterization capabilities
- 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
Industry-leading support for monoclonal antibody specificity and sensitivity testing
Within the next decade, the global therapeutic antibody market is expected to double, partly due to the addition of emerging technologies such as phage display. In addition to navigating established analytical challenges, including screening multitudes of clonal variants for specificity, drug developers and researchers must be proactive about the scalability of process methods.
Element’s scientists understand the impact of solubility, stability, and distribution in monoclonal antibody development. With a proactive QC-mindset, our teams work alongside clients to pre-empt manufacturing challenges, ensuring a holistic view of cell productivity and critical quality attributes is maintained throughout the entire engagement. Even with the additional complexities brought on by antibody humanization and glycosylation, we generate needed data efficiently and effectively, helping companies reach their commercial goals.
The Element advantage
Element is committed to providing comprehensive scientific and regulatory support to the world's leading healthcare brands as they develop and bring leading-edge monoclonal antibody therapies to market. From optimized method development and validation for long-term manufacturing efficiency, to providing guidance on data and documentation needed to meet regulatory requirements the first time around, Element’s full-service solutions extend across the entire product development lifecycle. Facilitate a smooth transition as you prepare to manufacture at scale and realize the full potential of your mAb with our skilled tech transfer capabilities.
For more information about Element’s monoclonal antibody (mAb) analysis and characterization services or to request a quote, contact us today.
- 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
Biopharmaceuticals and Biologics Analysis
Element’s significant expertise in all stages of biologics R&D, from in-house protein biochemistry and molecular biology to cellular biology and QC experience, supports the entire product development life cycle.
Therapeutic Protein Analysis
Element provides a variety of therapeutic protein analysis and characterization services to design molecule-specific analytical strategies in support of IND and BLA regulatory pathways.
Element’s comprehensive bioanalytical testing services are dedicated to bringing industry-leading scientific expertise to help customers advance drug development programs.
Aseptic Manufacturing & Sterile Fill-Finish
Element offers comprehensive sterile fill-finish solutions tailor-made to support clinical studies, compounding pharmacies and small-scale batches, including small bulk fills.