K.K. Jain, Textbook of Personalized Medicine, DOI 10.1007/978-1-4939-2553-7_9, 189
© Springer Science+Business Media New York 2015
Chapter 9
Personalized Biological Therapies
Introduction
Historically blood transfusion and organ transplantation were the fi rst personalized
therapies as they were matched to the individuals. Some cell therapies that use
patient’s own cells are considered to be personalized medicines particularly vac-
cines prepared from the individual patient’s tumor cells. More recently recombinant
human proteins might provide individualization of therapy. The number of
biotechnology- based therapeutics introduced in medical practice is increasing along
with their use in a personalized manner (Jain 2012 ).
Recombinant Human Proteins
There are a large number of therapeutic proteins approved for clinical use and many
more are undergoing preclinical studies and clinical trials in humans. Most of them
are human or ‘humanized’ recombinant molecules. Virtually all therapeutic proteins
elicit some level of antibody response, which can lead to potentially serious side
effects in some cases. Therefore, immunogenicity of therapeutic proteins is a con-
cern for clinicians, manufacturers and regulatory agencies. In order to assess immu-
nogenicity of these molecules, appropriate detection, quantitation and
characterization of antibody responses are necessary. Immune response to therapeu-
tic proteins in conventional animal models has not been, except in rare cases, pre-
dictive of the response in humans. In recent years there has been a considerable
progress in development of computational methods for prediction of epitopes in
protein molecules that have the potential to induce an immune response in a recipi-
ent. Such tools are already being applied in the development of therapeutic proteins.
It is expected that computer driven prediction followed by in vitro and/or in vivo
testing of any potentially immunogenic epitopes will help in avoiding, or at least
minimizing, immune responses to therapeutic proteins. It is possible to develop