Abstracts Book - IMRC 2018

• SB2-P020
PHYSICOCHEMICAL CHARACTERIZATION AND COMPARISON OF
THE BIOLOGICAL ACTIVITY, IN A MODEL OF ARTHRITIS, OF THREE
ANTIBODIES ANTI TNF-α
Elvia Zárate 1,2
1 Dixpertia Investigación Biofarmacéutica y Farmacológica S.C, Laboratorio de biotecnología,
Mexico. 2 Universidad Autónoma de San Luis Potosí, Pharmacology, Mexico.
Background: As a result of that in recent years a lot of innovative biotech drugs
have lost their patent, So called biosimilares have been gaining ground in the
broad market. Because of this, it becomes crucial role comparability exercises
physico-structural and biological activity in vivo (preclinical assay) to ensure drug
safety level.
Objetive: To compare the physicochemical quality and biologic activity of two
drugs biosimilar ( drug 1 and drug 2) of Etanercept and that they were produced
by two different process respect innovator drug Enbrel® in a arthritis
experimental model.
Methods: The drugs of Etanercept (Drug 1 and Drug 2) were compared using
test of identy and structure as content of protein, mapping peptide,
Glycosylation profile and impurities profile by Size Exclusion Chromatography
and Ion Exchange Chromatography. The biological activity was tested with an
experimental animal model of arthritis induced by Complet Adjuvand Freun´s
in mouse. The arthritis induction were tested of comparative form in the
behaviors behaviors of pain, functional disability and edema knee as surrogate
an pharmacology respond of biosimilar of Etanercept.
Results: For identity assay by mapping peptide, the 3 drugs to show profiles very
similar. When tested of quality of biosimilar by SEC-UHPL and IEX-UHPL. One lot
of Enbrel® to show 3% in presence of dimer, while that a profiles of IEX is too
similar. The presence of glycations in each drug is similar, the one drug to show
higher density of G0 in the portion Fc and one additionally glycan not identify.
The biologic activity of Enbrel® and two biosimilar to show an activity similar on
control of pain behaviors, functional disability and edema knee their biosimilar
respect Enbrel®.