Molecular Size Variation Analysis Service
Molecular size variation analysis is an essential method for evaluating the integrity and aggregation state of protein molecules. It is widely used in the research, development, production, and quality control of biopharmaceuticals. By detecting the main protein peaks and their high- and low-molecular weight variants, this analysis can identify potential aggregates, cleaved forms, unfolded monomers, and degradation products. These insights are crucial for evaluating the stability, safety, and batch consistency of drugs.
As biopharmaceutical products become more complex, accurate molecular size quantification has become a key part of establishing quality standards and preparing CMC (Chemistry, Manufacturing, and Controls) documentation. Various analytical platforms provide complementary information under both denaturing and native conditions, enabling multidimensional analysis of protein molecular states. This provides critical data to support process optimization, impurity profiling, and final product release.
MtoZ Biolabs offers Molecular Size Variation Analysis Service by leveraging high-resolution electrophoresis and chromatography platforms. We integrate diverse molecular size analysis strategies to sensitively detect protein variants and provide comprehensive quality assessment support for biologics at every stage—from construct design and screening to commercialization.
Services at MtoZ Biolabs
MtoZ Biolabs offers a variety of complementary Molecular Size Variation Analysis Services, which can be applied independently or in combination based on specific research needs and protein properties:
1. SDS-PAGE
Using SDS denaturing polyacrylamide gel electrophoresis, protein bands are separated and molecular weight differences are visually displayed. This service is ideal for preliminary screening and verifying the structural integrity of protein expression products.
Figure 1. Analysis of Molecular Size Variability via SDS-PAGE
2. CE-SDS
This service combines SDS denaturation with capillary electrophoresis, offering high resolution and automation. It supports quantitative analysis under both reducing and non-reducing conditions and is widely used in quality research, process optimization, and regulatory submission support.
Figure 2. Analysis of Molecular Size Variability via CE-SDS
3. SEC
Using Size Exclusion Chromatography (SEC), proteins are separated under native conditions based on their molecular volume. This method is crucial for assessing the ratio of aggregates, oligomers, and monomers, providing insights into protein stability and aggregation tendencies.
Figure 3. Analysis of Molecular Size Variability via SEC
We also offer customized multi-platform collaborative analysis to enhance the depth and accuracy of structural variation detection based on sample characteristics and analytical goals.
Why Choose MtoZ Biolabs?
✔ High-Resolution Separation Platforms: Equipped with advanced capillary electrophoresis systems, Bio-Rad SDS-PAGE systems, and Agilent/Waters high-performance SEC systems, we ensure clear separation and accurate quantification of proteins.
✔ Multi-Platform Collaborative Analysis: Our multi-technique analysis supports both denaturing and native conditions, enabling the identification of structural differences in proteins and improving detection coverage and mechanistic analysis.
✔ Broad Protein Sample Compatibility: Our Molecular Size Variation Analysis Service is compatible with various sample types, including monoclonal antibodies, bispecific antibodies, fusion proteins, vaccine antigens, and enzyme preparations. It is suitable for proteins at different stages of development and from various production platforms.
✔ High Throughput, Standardized Testing Process: We provide automated testing and parallel sample handling capabilities, meeting the demands of multi-batch, high-repetition, and stability studies.
Sample Submission Suggestions
The Molecular Size Variation Analysis Service is suitable for various protein samples, including recombinant proteins, antibody drugs, and vaccine antigens. Samples should have good purity, and the buffer system should not interfere with the separation performance.
Please contact us for detailed sample preparation and shipping guidelines.
Applications
MtoZ Biolabs’ Molecular Size Variation Analysis Service can be widely applied in the following stages of research and development:
· Candidate Molecule Screening & Structural Integrity Verification: Evaluate the cleavage, degradation, or aggregation phenomena in expressed proteins or process constructs.
· Stability Studies & Stress Testing: Analyze protein structural changes under heat, freeze-thaw, or acid-base conditions, supporting process optimization and excipient selection.
· Batch Consistency & Quality Release Assessment: Compare molecular size distributions of proteins from different production batches to establish quality evaluation standards.
· Impurity Profile Construction & Regulatory Support: Identify high- and low-molecular weight impurities outside the main component, providing quantitative data and spectrum descriptions to support CMC documentation preparation.
· Formulation Development & Storage Stability Analysis: Verify protein molecular states under different pH, excipients, and buffer systems to provide data for drug formulation design.
MtoZ Biolabs is committed to providing scientifically rigorous and compliant Molecular Size Variation Analysis Service, helping accelerate product development and enhance quality control. Please contact us for a free evaluation and customized technical support.
FAQ
Q1: Can SEC differentiate between different types of oligomers, such as dimers and trimers?
SEC effectively separates oligomers with significant molecular weight differences, such as monomers, dimers, and trimers, with strong resolution when the molecular weight difference exceeds 10%. For high-molecular-weight oligomers or asymmetric molecular systems, we recommend combining with MALS (Multi-Angle Light Scattering) to improve molecular structural characterization accuracy. MtoZ Biolabs offers a complete SEC-MALS system, supporting high-precision oligomer state analysis.
Q2: How should low-concentration samples or those with complex excipients be handled? Will this affect the analysis?
Low-concentration samples may lead to unclear peaks or insufficient detection limits. Samples containing salts, glycerol, surfactants, or excipients may affect migration behavior or SEC column efficiency. MtoZ Biolabs’ experienced technical team can design desalting, dilution, or buffer exchange strategies based on sample properties to ensure sample compatibility and improve detection sensitivity, enhancing analysis success rates.
What Could be Included in the Report?
1. Electrophoresis or chromatography spectra and quantitative results
2. Brief description of experimental steps and methods
3. Reagent and instrument information used in the analysis
4. Technical analysis and conclusion summary
5. Complete technical report (PDF format), suitable for regulatory submission or internal archiving
Related Services
Molecular Weight Determination Service
Protein Molecular Weight Determination Service
How to order?
