Protein Aggregation Analysis Services
Detailed analysis and prevention of protein aggregation is one of the major challenges in the development and commercialization of biologics and biosimilars. Aggregation of protein-based drugs can occur at all stages of development, manufacturing and storage, as many biopharmaceuticals are inherently prone to physical and chemical instability. For robust quality control, stability studies and process optimization, it is essential to distinguish between reversible vs. irreversible and soluble vs. insoluble aggregates and to quantify and characterize their occurrence in detail.
Protein aggregation can directly affect efficacy, by reducing the fraction of functional monomer, and compromise safety, for example by inducing cytotoxic effects or unwanted immunogenicity. Regulatory authorities expect a science- and risk-based aggregation control strategy, supported by stability-indicating, orthogonal analytical methods.
At Biofidus, our experts design fit-for-purpose aggregation analysis panels aligned with your CMC and regulatory needs, providing you with suitable bioanalytical packages for development, release, comparability and troubleshooting.
In line with your requirements, we adapt and, where necessary, qualify (according to ICH guidelines) our platform methods, tailoring them to your drug substance, its formulation matrix and your specific analytical questions (e.g. formulation screening, process changes, scale-up, device compatibility).
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.
