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Dr. Michael Brown, Director of Immunoassay, ICON Laboratory Services, says a key strength of their Bioanalytical Services Group is their ability to take very difficult targets in difficult matrices and develop very robust and sensitive assays to support their Sponsors’ programs. Gyrolab xP workstation has helped them in this, providing high throughput, phenomenal precision, and an open system to support method optimization and validation.
ICON’s adoption of Gyrolab xP workstation has been driven by Sponsor requirements. As Michael explains, “We recognize the need to support the programs that our Sponsors outsource on the platforms that are most appropriate for their drug development challenges. Many Sponsors have the Gyrolab system in-house, so we’ve brought multiple systems on-line to meet demands in transferring Gyrolab assays into our GLP laboratory”. The Immunoassay Laboratory currently uses the Gyrolab systems to optimize, validate and run PK, biomarker and ADA assays.
A key strength of the Gyrolab system has been throughput, which is critical in Phase III trials. Michael explains, “A number of Sponsors transfer ELISAs to the Gyrolab system for Phase III studies to meet critical timelines, and this is where we see the key strength of Gyros technology – walk away automation to remove the throughput bottleneck often encountered in Phase III. The systems typically run at least twice a day, with minimal hands-on time compared to plate-based ELISAs”. For example, ICON and a pharmaceutical Sponsor met critical timelines by combining forces and running in parallel a total of six Gyrolab systems, each running five CDs two to three times per day, to analyze 27,250 samples in six weeks using two quantitative PK assays.
In a second example, Michael related how, over the course of two weeks, ICON analyzed 2,756 PK samples in a Phase III bioequivalence study using two Gyrolab xP workstations, together running up to 20 CDs per day. Only one of the 118 runs failed, due to QC failure. The inter-run CV was less than, or equal to 7.5%, and the RE ranged from 0.73% to 7.7%. All the ISRs met acceptance criteria.
The ability of the Gyrolab system to handle small sample volumes has also become a clear benefit for ICON in recent years, giving them the ability to address the increasing intensity of analyte testing. “The majority of the sample is often used for multiple biomarker assays, rather than for PK analysis, so getting more information from precious biological samples is crucial. The Gyrolab system can also handle high matrix levels, which means less dilution errors and higher sensitivity”.
The availability of tools such as Gyrolab Viewer, combined with flexible and responsive support, has speeded assay development. Conversion from ELISA to Gyrolab assays is very dependent on reagent quality, and the availability of anti-idiotypic antibodies is a clear advantage. When reagent quality threatens to compromise assay performance, Michael and his team appreciate the flexibility of Gyrolab technology, for example in accommodating off-line pre-incubations.
Michael concludes, “Pharma companies continue to increase outsourcing and CROs must boost efficiency to support them. So having very robust methods on a system like Gyrolab xP workstation will place CROs in a strong position to generate high quality data from large numbers of precious biological samples. This puts the Gyrolab system in a strong position to support CROs and pharma in developing and bringing to market medicines that will improve the quality of life for many.”
Operating from our GLP/GCP compliant laboratory, ICON has provided bioanalytical support for over 4,500 studies for both small and large molecules. Our responsive teams of experts have earned a reputation for innovative method development and timely, high-quality analytical services that are personalized to meet each client’s specific application. We provide both stand-alone immunoassay and mass spectrometry services, as well as the bioanalytical component of full-service packages across all phases of development.
We develop robust, reliable and fully validated assays to the highest of standards. We have extensive experience in the development and validation of assays that are highly sensitive, precise and accurate. With a standard-setting run repeat rate of less than 5%, we are able to generate timely results in keeping with our clients’ timelines. We deliver fully QC reviewed data to our Sponsors within 5 days of study completion.
We ensure that each client gets the close attention they require, with direct access to our senior scientists to help you overcome the most demanding drug development challenges.
ICON’s bioanalytical sciences group has developed over 3,000 new assays to serve our clients. The immunoassay services group offers ICON-proprietary assays to support the development of Biosimilars. Our mass spectrometry group offers a list of validated assays to support DDI studies, and generic drug applications.
ICON Laboratory Services offers leading expertise in laboratory biomarker solutions praised by our clients for our unique, customized approach to delivering personalized solutions.
We support the development and analysis of a broad range of biomarker assays across many therapeutic areas, using a large array of analytical platforms and technologies, including Immunoassay and LC-MS/MS at ICON Bioanalytical Laboratories; Flow Cytometry, IHC as well as chip-based and bead-based multiplexing platforms are used at ICON Central Laboratories. With close links to our in vivo clinical pharmacodynamics group, we can provide a full suite of clinical and analytical biomarker services to support our clients’ development efforts.
Find out more at www.iconplc.com