Agile BioScience: Unmatched Aggregate Analysis with SEC-MALS
SEC-MALS is a gold-standard technique for characterizing protein services aggregates and determining absolute molecular weight. Agile BioScience offers expert SEC-MALS analysis to ensure the quality and safety of your biopharmaceuticals, supporting your regulatory submissions.
Why SEC-MALS Matters:
- Size & Quantitation of Aggregates: SEC-MALS simultaneously separates protein species based on size and determines their precise molecular weight, enabling accurate quantification of aggregates.
- Independent of Reference Standards: Provides direct molecular weight determination, unlike traditional SEC that relies on standards.
- Supports Regulatory Expectations: Delivers the type of robust aggregate characterization data often requested by regulatory authorities.
Our Approach:
- Integrated Analysis: We combine SEC-MALS with complementary techniques (e.g., SDS-PAGE, AUC) for orthogonal confirmation of aggregation.
- The MALS signals, along with UV absorbance and/or differential refractive index (dRI) signals, are analyzed to quantify the analyte’s physical properties.
- Data-Driven Guidance: We go beyond data generation, providing insights to aid in troubleshooting aggregation and ensure product quality.
Benefits of Choosing Agile BioScience:
- Confidence in Aggregate Characterization: Obtain accurate and reliable data on aggregation levels.
- Streamlined Development: Identify and address aggregation issues early, accelerating your timeline
- Regulatory Success: Our SEC-MALS data supports your product submissions and demonstrates a commitment to quality.
Contact us to learn how SEC-MALS can empower your biopharmaceutical development.
Characterization
- Dynamic Light Scattering (DLS)
- Micro Flow Imaging (MFI)
- Liquid Chromatography
- Circular Dichroism (CD)
- SV-AUC
- Fourier-Transform Infrared (FTIR)
- Differential Scanning Calorimetry (DSC)
- Secondary, Tertiary and Higher Order Protein Structure
- CE-SDS
- Image Based Capillary Electrophoresis
- Intact Molecular Weight Analysis
- Oligosaccharide Profiling Services
- Disulfide Bond Mapping Services
- N- and O-linked glycosylation services
- Peptide Mapping Services
- C-terminal Sequencing
- N-Terminal Sequencing
- Amino Acid Analysis
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