Aggregate Analysis Service

The aggregation of biological drugs occurs during the development, production, and use of biological drugs and is frequently triggered by the nature of biological drugs (such as the properties of different proteins), the stimulation of external temperature or other physical factors, and the mixing of foreign substances.

Aggregation not only reduces the effectiveness of the medicine but also causes shock and other immune-related symptoms, which in extreme circumstances can be fatal. Our company provides knowledgeable aggregate analysis services to assist customers in accurately defining, recognizing and quantifying protein aggregates.

Service Overview

To identify potential protein aggregates that can improve the biotherapeutic's overall purity, an aggregation analysis is carried out. Numerous factors, such as storage conditions, handling circumstances, formulation buffer composition, etc., can cause aggregates to form. Traditional tests for subvisible aggregated particles often combine numerous assays to get coverage of the whole particle size range due to the constraints of the particle size range.

Our company uses separation with size exclusion chromatography (SEC) and quantification with a UV-VIS detector to determine any aggregates or subvisible particles in a dosage formulation. To monitor bioanalytical reagents both before and after binding to biotin, sulfate tags, etc., we also use a number of tools and methods.

Our protein aggregation analysis techniques include, but are not limited to:

• Analytical Ultracentrifugation (AUC)
• SEC, SEC-MALS
• Dynamic Light Scattering (DLS)
• Zeta Potential
• Circular Dichroism (CD)
• Capillary Electrophoresis CE (CZE, MECC, gel CE, cIEF/iCIEF)
• Gel Electrophoresis (Native, SDS-PAGE, IEF)
• Electron Microscopy (TEM and SEM)

Our company can expedite your protein aggregate characterization requirements to support client formulation development, quality control, stability studies, comparability, release testing, and aggregation studies thanks to our exceptional level of knowledge and experience.

Research Capabilities

To identify and measure aggregates in solution, Our company uses a variety of protein aggregation analysis techniques, including:

• The development of aggregates or oligomers in solution can be studied using differential scanning calorimetry (DSC), AUC, and DLS.
• AUC enables the qualitative assessment of the existence of aggregates in a wide range of molecular weights, from a few kDa to MDaltons, as well as the homogeneity of protein/peptide solutions. Multiple species can be uniquely analyzed using AUC in the same dataset.
• SEC is frequently used to identify and measure irreversible aggregates, ranging from oligomers to ultra-high order aggregates, in submicron aggregates. This method is frequently combined with multi-angle static light scattering to estimate the molecular weight of the detected aggregates.
• Protein particle size distribution in solution, particle size analysis, and electrostatic aggregation can all be measured using data produced by DLS. DLS can be used to analyze and detect nanoparticles in nutraceuticals, such as nanoliposomes that have been encapsulated.

Overall Solutions

For more information, please feel free to contact us.

It should be noted that our service is only used for research, not for clinical use.