Biopharmaceutical characterization and development are complex, multi-faceted procedures which stretch from discovery to product release. The majority of product characterization takes place during relatively early development, and much of this work is designed to establish the comparability of different batches of material produced throughout the development pipeline, and to understand the influence of any process changes, measured against a reference standard. Comparability is a key attribute for biosimilar products in particular, and as the market for these drugs continues to swell, so will the analytical demands on their development. In addition, studies are performed in order to assess the stability of biotherapeutic molecules in formulation over a period of time, and discover whether temperature, pressure, time or pH, for example, impact the product's integrity and activity.
Protein therapeutics are inherently challenging to characterize because of their complexity and natural heterogeneity. There is therefore a requirement for comprehensive orthogonal testing to ensure meaningful and reliable characterization and provide as much data as possible in order to satisfy regulatory requirements concerning the product's identity, purity, concentration, impurity profile and potency. The more techniques employed to measure such parameters, the more sure the developer and regulators can be of product quality and safety.
We provide a wide range of solutions and tailored expertise to enable the thorough and reliable characterization of your product, ultimately assisting you to meet regulatory requirements and mitigate risks early on in development, accelerating your time to market and minimizing your costs.
Our suite of Zetasizer instruments can help you to monitor sample stability, detect early aggregate formation in protein formulations and study the thermal stability of proteins. Viscotek size exclusion chromatographs allow you to quantify the proportion of aggregates present, measure molecular weight and identify oligomeric state, and also study conjugation and structural changes. Our exciting new solutions, such as the Viscosizer TD, Archimedes, and the range of Nanosight instruments, will supply even further detail to support product development and characterization. Whatever the analytical challenge you face, Malvern has the perfect solution for you.