High Throughput Formulation Development of Therapeutic Proteins

Advancements in the fields of molecular biology and biochemistry have led to a significant enrichment in therapeutic proteins pipelines. Currently there are greater than a thousand biotherapeutic products in development and clinical trials. The number of candidates and their variety demands more efficient decision making at both the early and late stage of development. Furthermore, the standard of product quality has improved tremendously throughout the biotech and pharmaceutical industry and it has become extremely critical to accurately assess therapeutic proteins as early as possible. Formulation development is a critical step in the process leading toward efficient, safe and stable commercial products. Due to tight timelines and constrained resources available during early and late formulation studies, the amount of information that can be obtained is often limited. For these reasons, methods with higher throughput capability provide a huge advantage by expanding the conditions and parameters that can be tested. This presentation is focused on the development and application of high throughput methods that can lead to a faster and better evaluation of formulation properties and the improvement of biopharmaceutical development. We describe several analytical and accelerated stress techniques combined into one methodology in order to obtain a comprehensive characterization profile and ultimately to predict quality parameters of protein formulations. Statistical methods of experimental design and analysis were used to estimate the interactions along with significance of multiple factors and to create robustness stability space. Case studies for monoclonal antibody formulations will be presented.