Introduction into Formulation Development of Biologics

Formulation development is an essential part of every biopharmaceutical development program and important for the therapeutic and commercial success of a protein drug product by assuring the quality, safety, and efficacy. The multiple phases of formulation development interact with other product development exercises as early as discovery research all the way until and beyond market approval. Every drug product demands a tailor-made formulation, due to the complexity of different degradation pathways potentially affecting product stability, the specific characteristics of the individual drug molecule, special patient needs, and even marketing considerations. Formulation development can be approached using various strategies, based on a rational design, relying on scientific knowledge in low or medium throughput, or high-throughput formulation screening of hundreds or even thousands of conditions employing miniaturized analytical methods. In this chapter, an introduction to the field of protein formulation development is given, the literature on current protein formulation development strategies is reviewed, and current challenges are summarized.