Gyrolab: The Platform
Gyros Protein Technologies AB developed Gyrolab platforms using “reproducible nanoliter microfluidics and sequential CD processing” for efficient immunoassay runs. The first immunoassay system for nanoliter-scale protein quantification was released in 2003 at Drug Development Tool (DDT), Boston. In 2009, Gyrolab xP launched a new software designed for 21 CFR part 11 compliance and extended validation support. It miniaturizes immunoassay and integrates reagents (capture and detection antibody), sample addition, and CD washing into a single machine. For pharmacokinetic (PK) studies, it has brought advantages like broader dynamic ranges, shorter time to results, reduced sample and reagent volumes, and automated programs.
The Gyrolab system works with its proprietary CD technology engineered with highly reproducible nanoliter microfluidics. Each CD has 96/112 channels depending on the CD type and each channel has an individual sample addition inlet. Through precise, automated control of CD spin, capillary forces steer liquid flow through nanoliter-scale microfluidic structures in each CD channel and form the sandwich format. Fluorescence data is collected from the assay and analyzed using the Gyrolab Evaluator software to obtain final protein concentrations.
Challenges and Advantages of Gyrolab
Different from MSD and ELISA platforms, which use disposal tips to transfer reagents and samples, Gyrolab uses needles to transfer samples. Because of the instrument’s design, carryover contamination checks are necessary to conduct during method validation. For optimal use of Gyrolab, Frontage’s bioanalytical team shows how carryover contamination checks can be performed to ensure smooth operation.
Unlike the MSD and ELISA platforms which can handle multiple plates parallelly, Gyrolab processes CDs in a sequential manner. One CD run can take 1 to 2 hours, and the last CD needs to wait about 4 to 8 hours on the machine to be processed. In this case, samples after MRD benchtop stability need to be established to make sure samples are stable on Gyrolab while waiting for analysis. For optimal use of Gyrolab, Frontage has performed “After MRD (minimum required dilution)” stability testing to mimic the delay in loading standards.
No doubt, the Gyrolab platform has several advantages over ELISA or MSD platforms. The broader standard curve range and the proprietary CD technology which uses affinity flow-through assay reduce the background noise significantly and increase the sensitivity. It runs in a shorter time and can utilize a smaller sample and reagent volumes, saving critical reagents. An ideal choice for preclinical drug development animal assays, which have limited sample volume, it is also suitable for clinical projects with many samples that need to be analyzed in a short time.
Using Gyrolab for your Immunoassays
With an increased need for high-throughput immunoassays using precious samples and uncompromised data quality in a limited time, it is critical to choose a CRO that can build quality assays and deliver robust data. Frontage’s Gyrolab team has deep expertise with analyzing any peptide, protein, or antibody, and with method validation using the Gyrolab platform either under GLP or Clinical environments.
Author’s Note: This article is written with support from Zhongqiang Qiu, Ph.D. from Biologics Service at Frontage Laboratories.