A Streamlined Compliant Ready Workflow for Peptide-Based Multi-Attribute Method (MAM)

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Nilini Ranbaduge, Ying Qing Yu
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A streamlined Peptide MAM workflow has been demonstrated on the BioAccord LC-MS System under the control of the compliant-ready waters_connect informatics platform. This MAM functionality can support and accelerate biopharmaceutical product development, process development, manufacturing, and QC lot release by enabling direct, sensitive, and selective attribute-based measurements that will complement and potentially replace existing conventional chromatographic and electrophoretic assays.

Specifically, this Peptide MAM workflow will generate clear and superior performance compared to previous efforts in this area: 1) The Peptide MAM workflow that is highly automated and intuitive to use by non-MS experts; 2) Automated RT alignment improves peak component tracking across injections, instruments and studies providing consistent attribute-based quantification; 3) Advanced algorithms and filtering tools minimize false positives for new peak detection; 4) Scientific Library functionality enables the seamless transition from characterization to monitoring with data traceability; and 5) SmartMS capabilities of the BioAccord System for attribute-based analysis allows experienced and novice MS users to operate a high-resolution MS instrument with confidence. These capabilities should enable routine adoption of peptide LC-MS attribute based biotherapeutic analysis not only within core biopharmaceutical development organizations, but also into the emerging areas of LC-MS process monitoring and QC lot release.

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