Introduction

The advent of recombinant biotechnology and efficient synthetic processes has facilitated the development of a wide variety of protein and peptide therapeutics. Although a plethora of delivery routes and methods have been examined for the administration of these materials, to date the administration of these molecules is dominated by injection. Of these injected molecules, only a few, mostly high-dose antibodies, are administered by intravenous (IV) infusion; the vast majority being delivered by subcutaneous (SC) injection. Further, efforts are ongoing to identify formulation strategies to allow delivery of highdose biopharmaceuticals such as antibodies that can also be administered by SC injection. Although SC injection is a prominent delivery route for many biopharmaceuticals, relatively little is known about specific events that might occur to these therapeutic agents following their injection into a SC site that could affect their pharmacokinetic (PK) properties, pharmacodynamic (PD) outcome(s), and metabolic fate.

The marketing of protein and peptide therapeutics has focused on SC injections as this route of administration can be performed at home by patients with minimal training. This strategy of limiting the involvement of health care professionals for the administration of therapeutic protein and peptide drugs has proven to be a critical component for widespread use of biotherapeutics. Further, the pharmaceutical industry has strived to make SC injections as pain-free, fast, and simple as possible to increase patient compliance and maximize the consistency of delivery for self-administered SC injections. This is particularly important for some protein or peptide therapeutics where, because of their PK and PD characteristics, patients perform multiple injections every day.

Presently, one of the few assessments made regarding the SC injection of a protein or peptide therapeutic is to compare its PK profile and overall bio-availability to that observed following an IV infusion. In some ways, this comparison is an important indicator of potential events that might occur at the SC injection site. These SC to IV comparisons, however, provide little, if any, specific information about events at the SC injection site. This chapter will examine some potential events that could occur to a protein or peptide therapeutic following its SC injection that might affect its PK profile, PD outcome, and metabolic fate. The goal of this examination is to highlight potential mechanisms that could result in undesirable outcomes for injected protein and peptide therapeutics.

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