This post was contributed by Russ Peloquin, SQI Diagnostics, Inc.
Isotyping the ADA response to therapeutic
proteins has become a significant aid for pharmaceutical and biotechnology
companies who intend to bring their compounds to the FDA for approval. It’s
also a key component for drug efficacy and ensuring the safety of patients
worldwide.
The traditional method to obtain a full
immune response to a given therapeutic would be to develop individual assays as
standard ELISAs or individual ECL tests for each isotype and immunoglobulin
subclass. The time and expense to do this can be extreme as well as too costly
to outsource to a CRO.
However, the ability to multiplex these
various isotypes and in following recent FDA recommendations, performing
epitope mapping of the protein of interest, yields the highest quality results
from a single sample in one or a few wells provides many advantages. The
advantages include reduction in human error, variability from one assay to the
next, significant reduction in labor and method development cost, as well as
getting the most detailed information in a single reaction. Choosing a
technology that has also shown to have superior drug tolerance with minimal
matrix interference also deserves attention.
Automation is also a key driver for many
laboratories’ decisions on which technology to choose. Although each project
may require various throughput efficiencies at various stages in the
development process, finding a technology that is automated provides a “grow
into” model that can well suit a lab’s need for both high throughput needs, as
well as lower throughput testing. A software that runs this automation and
assay development that is 21 CFR part 11 should also be a strong consideration.
Automation also lends itself to the
importance of judicious use of both therapeutic compound and study sample.
That’s why the technologies being evaluated should only need a minimum amount
of patient sample and drug of interest in order to yield the kind of
information that a multiplex technology can produce from a single well. This is
especially true for those drugs that treat rare diseases and those study
samples that are in low volume, quantity, and availability.
Although certainly not required by
regulators, a manufacturer that is a provider of clinical diagnostic IVD
(in-vitro diagnostic) FDA-cleared kits and is cGMP and ISO-certified, gives
researchers confidence in the technology’s robust QA and QC practices.
These ideas are not new to the bioanalytics
arena, but are becoming increasingly more important in the evaluation of
existing and new technologies to assess immunogenicity.
You can hear more on the latest in the field at the Immunogenicity
for Biotherapeutics conference. Join us October 20-22 in Boston, MA. Download
the agenda to see what’s on tap.
SAVE $100. Register here and use code XP1938BLOG.
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