Monoclonal Antibody (mAb) Characterization & Analysis services
Partner with Element to accelerate your mAb therapy development through regulatory approval. Our comprehensive characterization and analytical testing services help you overcome technical challenges, ensure compliance, and pre-empt manufacturing issues. From early development through commercial scale-up, we deliver the robust data you need to bring therapeutic antibodies to market faster in this rapidly expanding field.
What is monoclonal antibody characterization and analysis at Element?
Monoclonal antibody characterization and analysis are critical processes that evaluate the safety, efficacy, and quality of therapeutic antibodies before biomanufacturing. At Element, we provide comprehensive analytical testing and characterization services to ensure your mAb therapies meet regulatory requirements while maintaining optimal yield and reproducibility throughout development and manufacturing.
What can Element offer you for mAb characterization and analysis?
What we test
What we test
- Cell culture media
- Process impurities
- Host cell proteins
Key tests offered
Key tests offered
- 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
Methods and solutions offered
Methods and solutions offered
Benefit from our QC-minded approach to method development and validation, optimized for long-term manufacturing efficiency. Our skilled tech transfer capabilities ensure smooth transitions as you scale up, helping to prevent significant risks that could impact your monoclonal antibody characterization and analysis processes.
Cutting-edge equipment we use
Cutting-edge equipment we use
- 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
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Future-Ready Solutions
Future-Ready Solutions
Stay ahead of the rapidly expanding therapeutic antibody market (which is expected to double within the next decade) with our expertise in emerging technologies and scalable analytical methods. Our solutions are designed to support both current needs and future market developments, to help you build lasting therapeutic franchises.
Materials we test
What we test:
- Monoclonal antibodies
- Therapeutic proteins
- Clonal variants
- Cell culture media
- Process impurities
- Host cell proteins
Your Challenges, Our Solutions
Regulatory Compliance Complexity
Time-to-Market Pressure
Technical Development Hurdles
Manufacturing Scale-up Concerns
Why Choose Element
Complete Development Support
Quality-First Partnership
Advanced Technical Capabilities
Strategic Analytical Expertise
Frequently asked questions
What emerging technologies do you support in mAb development?
We support advanced technologies like phage display, helping you stay ahead of market growth while ensuring scalable process methods.
What is the market outlook for therapeutic antibodies?
The global therapeutic antibody market is expected to double within the next decade, driven by emerging technologies like phage display. This growth makes it crucial to have scalable, efficient analytical processes in place.
How do your testing services help with regulatory compliance for mAb therapies?
We provide comprehensive analytical testing that generates the data required for regulatory submissions, with a QC-minded approach that ensures the highest safety standards for your therapeutic antibodies.
What specific mAb characterization capabilities do you offer?
Our testing capabilities include concentration determination, purity assessment, protein identification, cellular potency testing, glycosylation and PTM determination, host cell protein detection, and stability analysis to support your development needs.
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