Development of high concentration protein biopharmaceuticals: the use of platform approaches in formulation development

Abstract

The development of highly concentrated solutions of monoclonal antibodies has become increasingly popular in biotechnology firms as doses increase, and the demand for sub-cutaneous injection formulations rises for reasons of convenience and compliance. Protein concentrations often exceed 100mg/mL. Unfortunately, the reduced success rate of commercialization of biotechnology products result in a situation in which the majority of biologics that enter clinical trials have a very low probability of becoming commercial products. Under these circumstances, the formulation scientist must make judicious use of his or her available time and resources and must avoid over-investing in early phase 1 compounds. This circumstance has driven many laboratories to develop so-called "platform formulations" in which a suitable, high concentration, robust formulation, or dosage form is utilized broadly across a number of early stage biologics at a savings of time and effort. This highly pragmatic approach increases the efficiency of developing early clinical candidates with fewer resources, while maintaining clinical flexibility, thus saving their effort for later stage candidates for which proof of concept has been demonstrated and for which a more optimized and robust formulation and process, suitable for commercial application, must be developed.