New Modalities

Abstract

This chapter defines and discusses some novel modalities and specifically describes the current bioanalytical strategies and challenges associated with the development of these molecules. One of the new modalities that is currently under intensive investigation are bispecific therapeutics. Bispecific molecules have the potential to undergo biotransformation, or cleavage via proteases or other mechanisms into structurally distinct proteins that may retain all or some of their therapeutic effect. Immunogenicity testing for bispecific antibodies is generally conducted using traditional ligand-binding assays. The first successful gene therapy study for humans was conducted in May 1989. Informed by cumulative scientific data over several decades, the conventional wisdom regards the systemic drug concentrations as the driver for the pharmacological effects. This general principle has to be altered as tissue concentration is the driver for the pharmacological effects for the majority of available gene therapies.

Authors 2

1. Kelly S. Colletti corresponding Aachen Laboratory Sciences Charles River Laboratories

   Charles River Laboratories (Netherlands) · Charles River Laboratories (United Kingdom) · Charles River Laboratories (United States)

   Affiliation as printed

   Laboratory Sciences, Charles River Laboratories (corresponding author)

2. Mark Ma
   Affiliation as printed

   Translational Clinical Science, Rallybio