Detailed analysis and prevention of protein aggregation is one of the major challenges during the development and commercialization of biologics. Aggregation of protein-based drugs can be observed at all stages of the product development and storage, as biopharmaceutical compounds tend to be inherently unstable. For appropriate quality control and targeted development steps, it is necessary to distinguish between different aggregate formations such as reversible, irreversible, soluble and insoluble forms and to characterize their quantitative and qualitative occurrence in detail.
Protein aggregation can have a direct influence on the efficacy of the therapeutic product, due to a limited value of functional molecules as well as compromised safety, by inducing cytotoxic side-effects or unwanted immunogenicity. Our experts at Biofidus AG guide you in accordance with regulatory requirements and will provide you a suitable bioanalytical packages for an appropriate aggregation analysis.
In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your API, its individual formulation matrix and your distinct analytical question.
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.
Standalone and integral bioanalytical services
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Please reach out to Our expert Dr. Anja Doebbe for all requests regarding the assessment of product aggregations.
Phone: +49(0)521 89 739 064