Protein aggregation is a major concern for biotherapeutics as the aggregates may compromise the safety (by enhancement of immune responses thus causing adverse clinical effects) and efficacy of a drug product.
Although there is still no specific guidance on biopharmaceutical protein aggregates, regulatory agencies have clearly highlighted the need for the in-depth characterisation and monitoring of aggregation.
Quality Assistance can provide you with a set of state-of-the-art analytical techniques covering the full range of particle sizes needed to characterise the aggregation in your product. All these techniques are available in a GMP environment with qualified equipment and validated software. Methods can be validated according to ICH guidelines for subsequent use in release testing and stability studies.