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.
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