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SEC-MALS is a gold-standard technique for characterizing protein 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:

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• 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.

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Our Approach:

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• 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.

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Benefits of Choosing Agile BioScience:

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• 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.

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Contact us to learn how SEC-MALS can empower your biopharmaceutical development.