Multiplexing Phenotype and Function for More Biologically Relevant Insights - 30

Related Article from

Cell-Based Assays Keep Biosimilars on Track
The Assessment of Biologics Extends Beyond the Testing Range
By Meghaan M. Ferreira

T

he cell-based assay has become a mainstay of drug development, addressing
new concerns raised by the advent of biologics. These concerns include the
difficulties inherent in characterizing drug efficacy and patient safety in the
context of immunogenicity. Whereas small molecule drugs may escape detection
by the immune system, larger protein therapeutics, such as monoclonal antibodies,
are apt to trigger alarms.
"With the biologic molecules that we're making nowadays, it's not unusual at all
for a patient to generate an immune response," observed David Rusnak, director,
BioAnalytical Operations, BioAgilytix. "Some of those responses can be pretty
benign and not cause a lot of problems, but some of those responses can be much
more serious."
The formation of anti-drug antibodies (ADAs) can elicit allergic responses in some
patients; but a less obvious consequence, the loss or "neutralization" of drug
activity, can occur if an ADA interferes with drug function.
In what Rusnak refers to as the "the dawn of immunogenicity," researchers
discovered a rare neutralizing antibody (NAb) response to the recombinant
erythropoietin protein, used to treat anemia, that also neutralized endogenous
erythropoietin. The inactivation of both the body's naturally produced erythropoietin and the recombinant version left it unable to produce red blood cells, resulting
in pure red cell aplasia-a potentially lethal condition. "So it's absolutely critical
that immunogenicity testing is done," insisted Rusnak, "It's not only a requirement,
but it's a requirement for a very good reason."
The increasing popularity of biologics has made immunogenicity assays a critical
component for delivering safe and efficacious products to the market, but the
development and implementation of these assays present new technical chal30

| January, 2019

BioAgilytix
scientists are
collaborating
with other
scientific
innovators on
strategies for
developing
cell-based
functional
assays for
neutralizing
antibody
detection and
lot release
testing.


http://www.genengnews.com

Multiplexing Phenotype and Function for More Biologically Relevant Insights

Table of Contents for the Digital Edition of Multiplexing Phenotype and Function for More Biologically Relevant Insights

Contents
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 1
Multiplexing Phenotype and Function for More Biologically Relevant Insights - Contents
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 3
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 4
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 5
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 6
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 7
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 8
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 9
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 10
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 11
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 12
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 13
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 14
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 15
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 16
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 17
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 18
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 19
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 20
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 21
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 22
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 23
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 24
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 25
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 26
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 27
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 28
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 29
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 30
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 31
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 32
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 33
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 34
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 35
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 36
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 37
Multiplexing Phenotype and Function for More Biologically Relevant Insights - 38
https://www.nxtbookmedia.com