Antibody Stability Assessment

Antibodies are complex protein molecules that can be affected by a variety of factors, such as temperature, pH, agitation and storage conditions. These factors can lead to changes in the structural integrity and function of antibodies, ultimately affecting their stability. The stability of antibodies is critical to maintaining their potency, specificity and binding affinity.

To ensure the quality and efficacy of antibodies, a thorough stability assessment is essential. Creative Proteomics offers comprehensive stability studies using advanced technology and expertise gained over many years.

What We Can Do:

  • Utilize dynamic light scattering (DLS) to analyze the size distribution and aggregation state of antibodies.
  • Employ nano differential scanning fluorimetry (nanoDSF) to assess the thermal stability and unfolding behavior of antibodies.
  • Utilize hydrophobic interaction chromatography (HIC) to evaluate the hydrophobic properties and stability of antibodies.
  • Apply size exclusion chromatography with multi-angle light scattering (SEC-MALS) to determine the molecular weight and oligomeric state of antibodies.
  • Combine these advanced techniques to provide a comprehensive assessment of antibody stability, structural integrity, and quality.
  • Generate data-driven recommendations for optimal formulation, storage, and handling conditions based on the results obtained from these techniques.
  • Assist in the development of strategies to enhance antibody stability, prevent aggregation, and improve overall product quality.
  • Offer expertise in interpreting and analyzing the complex data generated by these techniques to provide actionable insights for clients.
  • Ensure efficient and timely delivery of stability assessment results to support clients' antibody development and manufacturing processes.
  • Collaborate closely with clients to understand their specific needs and goals, providing customized solutions for their antibody stability assessment requirements.

Technology Platform for Antibody Stability Assessment at Creative Proteomics

Assessment of colloidal stability by dynamic light scattering (DLS):

DLS provides information about the size distribution and aggregation state of antibody samples by measuring the intensity fluctuations of scattered light.DLS is able to identify and quantify the presence of aggregates, which may lead to reduced efficacy or adverse immune responses.

Characterisation by dynamic light scattering (DLS) of stability of SLN-ACharacterisation by dynamic light scattering (DLS) of stability of SLN-A (Francis et al., 2020)

Thermal stability assessment with NanoDSF:

NanoDSF enables precise assessment of the thermal stability of antibodies. By measuring the fluorescence of intrinsic tryptophan and tyrosine, NanoDSF detects changes in the tertiary structure of antibodies with temperature. This information enables the determination of melting temperature (Tm) and the assessment of protein stability under various thermal conditions. Using NanoDSF technology, it can help optimize the formulation and storage conditions of its antibody therapeutics.

Analysis of mAb stability by nanoDSF with backreflection aggregation detectionAnalysis of mAb stability by nanoDSF with backreflection aggregation detection (Breitsprecher et al., 2016).

Chemical Stability Assessment with HIC:

HIC is used to assess antibody chemical stability. HIC separates molecules based on their hydrophobicity, providing information about structural changes, aggregation and degradation products.

References

  1. Francis, Jasmine E., et al. "Solid lipid nanoparticle carrier platform containing synthetic TLR4 agonist mediates non-viral DNA vaccine delivery." Vaccines 8.3 (2020): 551.
  2. Breitsprecher, D., et al. Getting the Full Picture: Predicting the Aggregation propensity of mAbs Using Chemical and Thermal Denaturation on a Single, Fully Automated Platform. Application Note NT-PR-011, 2016:[7 p.], 2016.
* This service is for RESEARCH USE ONLY, not intended for any clinical use.