Multiplexing Phenotype and Function for More Biologically Relevant Insights - 33

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facilitated the conversion of DiscoverX' bioassays to a ready-to-use format. Their
kit-based approach allows clients to "focus on what's most important for them,
which is running the assay," noted Abhishek Saharia, Ph.D., director, cell-based
assays and biologics, DiscoverX.
The simplicity of the ready-to-use format has another huge advantage for companies: transferability. "Our clients are working at multiple sites across the globe,"
explained Dr. Prasad. "It becomes imperative that any platform they adopt can be
easily transferred."
Developing NAbs for ADCs
Expiring patents for biologic drugs are ushering in the first generation of biosimilars. At the same time, a new generation of innovative therapies with complex,
multistep mechanisms is peeking over the horizon. For example, antibody drug
conjugates (ADCs)-targeted therapies comprised of an antibody, a linker, and a
toxin-rely on cell binding, internalization, and cytotoxicity steps for their therapeutic effect.
"If we think of the ADC as a guided missile, the antibody acts as the targeting
system and the toxin as the warhead" illustrated Shan Chung, Ph.D., senior scientist, bioanalytical sciences, Genentech. Although Dr. Chung emphasized that ADCs
have tremendous clinical potential, he also allowed that only a few ADCs, including
Genentech's Kadcyla for Her2-positive metastatic breast cancer, has made it to
market compared to the much larger number of monoclonal antibodies. He
attributed the discrepancy to the additional technical challenges ADC developers
face, including immunogenicity testing.
Dr. Chung asserted that the most formidable challenge in NAb assay development
is acquiring and characterizing antibodies that can serve as a positive control
for assay verification. Generally not available off the shelf, control antibodies are
produced by immunizing an animal with the drug, collecting and purifying the
ADAs generated, and confirming their ability to neutralize drug activity. ADCs
further complicate the acquisition process, because the control antibody needs to
react to all three components of the ADC.
"ADCs constitute one of the more difficult biologic classes when it comes to
developing NAb assays, and the primary reason for this is that you have both a
33

| January, 2019

Promega's PD-1/PD-L1 Blockade Bioassay consists of two genetically engineered cell lines:
PD-1 effector cells and PD-L1 aAPC/CHO-K1 cells. When the cells are co-cultured, the PD-1/
PD-L1 interaction inhibits the luminescence that is mediated by T-cell receptors (TCRs). When
the PD-1/PD-L1 interaction is disrupted, TCR activation induces luminescence via activation
of the nuclear factor of activated T-cell (NFAT) pathway. After addition of Bio-Glo Reagent,
luminescence may be quantitated with a luminometer.


http://www.genengnews.com

Multiplexing Phenotype and Function for More Biologically Relevant Insights

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Multiplexing Phenotype and Function for More Biologically Relevant Insights - Contents
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