Gyros launches Gyrolab xP, featuring enhanced ease-of-use, 21 CFR part-11 compliance and extended validation support
Gyros AB, the leader in immunoassays for therapeutic protein development, is pleased to announce the introduction of Gyrolab™ xP. Based on the company’s proven and highly successful platform for miniaturized protein quantification at all stages of drug development, this second generation system delivers enhanced ease-of-use, 21 CFR part 11 compliance, and extended validation support for smooth implementation in GLP-regulated environments. Gyrolab xP was presented at the opening of the 5th PEGS meeting in Boston, April 6 –10.
“Gyrolab is already firmly established within the pharmaceutical industry, as the preferred technology for applications such as pharmacokinetic (PK) assays and many biomarker assays,” stated Erik Walldén, CEO and president of Gyros. “With the introduction of Gyrolab xP, we now offer a complete solution which effectively addresses the need for enhanced productivity in the development of protein-based therapeutics by significantly reducing project timeframes and costs.”
“Seamless assay transfer is one of the hallmarks of this technology. With the added benefits that Gyrolab xP delivers, we now offer a system that is easier to use, and contributes significantly to a more robust workflow, increasing reliability, a key factor when outsourcing validated assays,” asserts Peter Steffner, VP marketing at Gyros. “European CROs and CMOs who have successfully implemented Gyrolab technology, are actively promoting this service as it gives them a competitive edge. Many organizations have validated assays that are currently in some phase of clinical sample analysis. Therefore, as Gyrolab xP enables straightforward implementation into GLP laboratories, we foresee a significant increase in; the demand for services performed with Gyrolab, and installed capacity during 2009,” he concludes.
Gyrolab xP was unveiled to over 50 European and US industry delegates from pharma, biotech, CRO and CMO organizations who met March 19 – 20 to specifically discuss how the accelerated development of therapeutic proteins brought by the Gyrolab technology improves the prospect for their respective organizations.
For Gyros AB
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About Gyros (www.gyros.com)
Gyros AB is the world leader in utilization of microfluidic technologies to miniaturize and automate immunoassays. The GyrosTM immunoassay platform increases productivity and efficiency during development of biotherapeutics and vaccines, saving time and labor. Major biopharmaceutical companies and their service providers utilize the Gyros platform to boost time-critical workflows and meet increasing regulatory demands.
Spanning the entire spectrum of immunoassays, the platform cuts the time to result significantly. Faster development times, and unattended running of assays at nano-liter scale, save labor and sample. The ease of assay transfer between sites and from development to regulated environments is unsurpassed in the industry.
The company is based in Uppsala, Sweden and has regional sales and support offices in the USA and Europe, and a growing network of distributors.