Abstract

Monoclonal antibodies (mAbs) are the fast-growing sector in biotherapeutics. Physical and chemical instabilities of those drug candidates pose different formulations and clinical challenges. Hence, this chapter will focus on the formulation of mAbs in the two different marketed dosage forms (dried powders and liquids) and how stabilization of therapeutic monoclonal antibodies can be enhanced with the application of techniques, buffers and excipients. Accordingly, lyophilization and diafiltration techniques will be covered in this chapter along with methods applied for characterization of their mAb products. Moreover, the current route of mAbs administration via parenteral route and its implication on formulation aspects (for example, high concentrated mAb liquid injections for subcutaneous route) will be discussed.