Gyros AB

Gyros launches Gyrolab xP, featuring enhanced ease-of-use, 21 CFR part-11 compliance and extended validation support

Pressmeddelande   •   Apr 08, 2009 09:57 CEST

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 further information, please contact:

Erik Walldén, CEO

Tel: +46 18-56 64 00

erik.wallden@gyros.com

Press relations

Linda van Manen, BGA Group

Tel: +31 78 631 97 15

linda.vanmanen@bgagroup.net

Notes to editors:

About Gyros AB

Gyros is the world leader in immunoassays for therapeutic protein development.

Gyrolab, the company's automated and open platform, is a versatile analytical tool that dramatically reduces the time required to optimize and execute immunoassays. Time for assay optimization is often cut from weeks, to a matter of days. This results in increased efficiency in process development and in clinical evaluation of therapeutic proteins. The ease of assay transfer is unsurpassed in the industry.

Gyrolab enables assays to be conducted with a significantly reduced background, increased dynamic range and with higher throughput. All this is achieved using only nanoliter volumes of reagents and sample. More data can be generated in less time and with higher precision, consequently improving productivity and effectiveness. Applications span the entire spectrum for immunoassays and Gyrolab is now firmly established as the preferred solution for pharmacokinetic (PK) assays in the development of therapeutic proteins.

Many major pharmaceutical companies and service providers - CMOs/CROs - have already implemented multiple Gyrolab platforms to boost their drug development process and to meet increasing regulatory demands on testing. Several validated assays are already in some phase of clinical sample analysis. Gyrolab xP complies with the requirements of 21 CFR part 11 and comprehensive validation support is provided.

The company has over 60 employees based at its headquarters in Uppsala, Sweden and at regional sales and support offices in the USA and Europe.