Title:Immunogenicity in Protein and Peptide Based-Therapeutics: An Overview
VOLUME: 19 ISSUE: 10
Author(s):L. Fernandez, R.H. Bustos*, C. Zapata, J. Garcia, E. Jauregui and G.M. Ashraf
Affiliation:Evidence-Based Therapeutic Group, Clinical Pharmacology, Universidad de La Sabana, Chia, Evidence-Based Therapeutic Group, Clinical Pharmacology, Universidad de La Sabana, Chia, Evidence-Based Therapeutic Group, Clinical Pharmacology, Universidad de La Sabana, Chia, Evidence-Based Therapeutic Group, Clinical Pharmacology, Universidad de La Sabana, Chia, Riesgo de Fractura S.A.-CAYRE, King Fahd Medical Research Center, King Abdulaziz University, Jeddah
Keywords:Immunogenicity, biosensor, peptide, biological drugs, anti-drugs antibodies, ADAs.
Abstract:Currently it is well known that all biological drugs, including those with a fully human structure,
are capable of inducing a host immune response known as immunogenicity [1]. The presence of
ADAs can condition the drug´s level and action, thus modifying the therapeutic effect and even the
safety profile by its mechanism of action - neutralizing or non-neutralizing - and / or an increase in its
clearance. Immunogenicity is a dynamic factor to be taken into account in biological therapy, especially
in long-term treatments, and as a relevant aspect in the assessment of secondary response loss [2]. With
the above, not only the knowledge but also the management of the immunogenicity of the different biological
treatments, represent a useful instrument for optimization of the strategies of use for each drug,
and in the design of predictive models of response, which finally permits a significant improvement in
the efficacy and safety profile, aiming to a personalization of the therapies, especially in patients with
autoimmune diseases, genetic disorders and cancer [3]. This review summarizes the events of immunogenicity
that produce the biological drug, the factor that influence to immunogenicity and the assessment
of immunogenicity.