End-To-End Analytical Solutions For Biologic Development: Method Development, Drug Characterization, And Routine Testing

At Mabion, we provide a comprehensive range of analytical services critical for the development, manufacturing, and commercialization of biologic drugs. Given the complexity of biologics, our state-of-the-art laboratories and expert team ensure precise, sophisticated testing from early development through to commercial launch. Our services cover every stage of the product lifecycle, maintaining the highest standards of quality, safety, and regulatory compliance. We offer method optimization, validation, advanced drug characterization, and bioanalytics, all tailored to the specific needs of your biologic.

Our precise monitoring of critical quality attributes (CQAs) and process parameters (CPPs) ensures product consistency, while rigorous cGMP release testing meets regulatory demands. We also provide extensive stability studies to determine shelf life and optimal storage.

Unlike many CDMOs, Mabion offers a wide array of bioanalytical services, supporting in vitro studies, pharmacokinetics, pharmacodynamics, and immunogenicity in early trials. All services are performed in compliance with ICH guidelines, EP, and USP standards, following a robust Quality by Design (QbD) approach for reliable results at every stage.

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