Compressing Drug Development Timelines with Accelerated Immunoassay - Recently developed immunoassay technology platforms reduce sample volume requirements and improve cycle times. - BioPharm

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Compressing Drug Development Timelines with Accelerated Immunoassay
Recently developed immunoassay technology platforms reduce sample volume requirements and improve cycle times.


BioPharm International
Volume 25, Issue 8, pp. 52-54, 56

GYROS

The Gyros is an automated immunoassay platform using a CD spinning disk technology, microfluidics, and a laser-based fluorescence detection system to quantitate monoclonal antibodies, drugs, proteins, and biomarkers from nanoliters of biological fluids. The immunoassay can be developed and be ready for sample analysis in three to five days, compared with other platforms that require weeks (see Case History). Instead of a well or a bead, the Gyros uses nanoliter columns packed with streptavidin beads positioned at the periphery of a plastic disk that is subsequently spun. Each column has a microfluidics channel system etched in the disk to carry reagents and buffers for washing steps. As the disk spins, centrifugal force moves the reagents at the appropriate time over the columns.

CHOOSING AN IMMUNOASSAY PLATFORM IN A TIME-CRITICAL ENVIRONMENT

When tasked with choosing the best platform and completing immunoassay development and core validation in less than two weeks, scientists must identify, purchase, and test commercial reagents for the assay. Each immunoassay that is run on the Gyros takes 70 minutes, compared with other technologies which require four hours or more, and in some cases overnight incubation while the reagents bind in each step. Scientists using Gyros can complete a number of experiments in a single day and then have a method ready in less than three days.

The sample volume for the Gyros is very low, requiring as little as six microliters, while other technologies may require as much as 100 microliters per sample. Because of the wide dynamic range of the Gyros assay, sample repeat runs are greatly reduced when compared with a traditional ELISA. Fewer sample repeat runs means greater overall efficiency.

The Luminex can run many ELISAs simultaneously (multiplex) to search for biomarkers, whereas the Gyros does not offer multiplexing capabilities. The MSD is a versatile platform commonly used for measuring antidrug-antibodies (ADAs) and MSD offers a number of multiplexing assay kits. Due to long assay run times, however, it takes two or more weeks to build a customized immunoassay on the MSD.

While commercial Gyros kits are not widely available, CROs and biopharmaceutical companies with Gyros technology custom develop assays to boost time-critical workflows, thereby meeting increasing regulatory demands on testing. For small, medium-sized, and virtual sponsor companies especially, outsourcing immunoassays to a Gyros-equipped CRO has clear advantages—fast development times, cost-savings from reduced timelines, along with no requirement for capital investment. The CRO can then perform unattended analyses at nanoliter scale, saving labor and reducing costs while conserving sample and reagents.

Mark J. Cameron is senior manager of biomarkers and immunoassay, MPI Research, 54943 North Main Street, Mattawan, MI, 49071.


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