Creative BioMart Chromatography offers professional protein aggregate analysis services to provide safety and quality monitoring for your therapeutic proteins. Protein is the ultimate executor of various activities needed to sustain life. Generally, the polypeptide chain from the ribosome in an unfolded conformation must adopt a defined three-dimensional structure (natural state) to be functional. In many cases, when this active conformation cannot be obtained or maintained, misfolded proteins tend to self-assemble to form insoluble aggregates (Fig. 1). Protein aggregates can be formed at any stage of the development or manufacturing process. The aggregation of proteins can lead to wrong drug doses, and can even trigger severe immune responses and other side effects. Therefore, the degree of such aggregation must be accurately characterized and analyzed under various conditions. We use the latest methods and technologies, our solutions include but are not limited to size-exclusion chromatography (SEC), SEC-HPLC, SEC-MALS, UPLC, HIC, micro-flow imaging (MFI), dynamic light scattering (DLS), capillary electrophoresis (CE), asymmetrical flow field-flow fractionation (AF4), etc.
Fig. 1 Overview of the proteostasis network (PN). (Pallarès I.; Ventura S., 2016)
Protein Aggregate Analysis Techniques
- SEC-MALS: MALS technology is a technology to determine the absolute molecular weight of proteins based on the direct correlation between the molecular weight of proteins and the intensity of light scattering. It does not require the use of standard proteins and does not depend on elution volume. The components separated by SEC enter the multi-angle light scattering detector, and MALS simultaneously measures the intensity of scattered light through multiple angles. The absolute molecular weight of the analyte can be directly calculated by using a formula. It is commonly used to detect and quantify irreversible aggregates ranging from oligomers to ultra-high order aggregates.
- Micro-Flow Imaging (MFI): MFI is a flow microscope technique in which bright field images are captured in successive frames as a continuous sample flows through a flow pool centered on the field-of-view of a custom magnification system with a well-defined and extended depth-of-field (Sharma D. K., et al, 2010). It can be used to distinguish protein aggregates from other particles.
- Dynamic Light Scattering (DLS): DLS is a technology based on the Brownian Motion, and the particle size was calculated according to the Stokes-Einstein formula by measuring the diffusion coefficient (D) of the particles. It often used to measure proteins ranging from microns to nanometers.
Our Specialty
- The technical team is experienced in testing and arranges the experiments in a timely and rigorous manner.
- We set up aggregation analysis in accordance with ICH Q6B guidelines, offering studies to either GLP or GMP.
- Standard calibration of testing equipment on time to ensure accurate and reliable test data.
- Professionals analyze test data and assist in solving technical problems effectively.
- Perfect and thoughtful pre-sales and after-sales service, and timely solve customers' questions.
Creative BioMart Chromatography has unique expertise and experience in protein aggregate analysis to meet your requirements for quality control, comparability, stability, submission, or batch release testing. We also provide custom services to meet the analysis of specific aggregation. Our customers have direct access to our experts and give timely feedback to any online inquiries. If you are interested in our services, please contact us.
How to Place an Order
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References:
- Pallarès I.; Ventura S. (2016). Understanding and predicting protein misfolding and aggregation: Insights from proteomics. PROTEOMICS. 16 (19), 2570-2581.
- Sharma D. K., et al. (2010). Micro-Flow Imaging: Flow Microscopy Applied to Sub-visible Particulate Analysis in Protein Formulations. AAPS J. 12, 455-464.
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