Macromolecular Reference Standards for Biotherapeutic Pharmacokinetic Analysis

Macromolecular Reference Standards for Biotherapeutic Pharmacokinetic Analysis  

Biologies may be considered a class of therapeutics directly purified from an original biological source. This category would include blood products, vaccines, and some hormones. Insulin, a peptide hormone (51 amino acids), is an example of a biologic that has been commercially available since about 1923 [ 1 ]. With the advent of 

This chapter is dedicated to Dr. Michael Hirsch, the invisible, unsung hero of so many, many immunoassays that he developed for all of us as his clients. His ready wit, sensibility, creativity, infectious enthusiasm, and pure love of life are sorely missed. The immunoassay world is simply not the same without him. 

Ligand Binding Assays Development, Validation, and Implementation in the Drug Development Arena. Edited by Masood N. Khan and John W.A. Findlay Copyright 2010 John Wiley Sons, Inc. 

Biopharmaceuticals and biologies, often grouped together as macromolecular therapies, or just macromolecules, differ in many ways from small-molecule chugs. The differences between these two general classes of therapeutics are summarized in Table 9.1. It is the very nature of these differences that necessitates different methods of bioanalysis as well as a dedicated look at both types of molecules as reference standards. 

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