New High-Performance System for Quality Control Applications Reduces Time for Assay Development and Validation
New High-Performance System for Quality Control Applications Reduces Time for Assay Development and Validation Biacore launches its first analytical SPR-based system for quality control applications in the regulated Pharmaceutical and Biotechnology sector Uppsala, Sweden, September 18, 2001. Biacore International AB (Biacore) (SSE: BCOR; Nasdaq: BCOR) today announced the launch of its BiacoreC system for rapid concentration analysis in drug development, manufacturing quality control (QC) and in-process control applications. Biacore C is the first SPR-based system for QC applications designed specifically for compliance with regulatory requirements. As drug companies are increasingly faced with the pressure of bringing new products to market faster while still maintaining strict compliance with Good Laboratory (GLP)/Good Manufacturing Practice (GMP), the validation of analytical systems and procedures becomes a major rate- limiting step. Biacore C was specifically developed with regulatory requirements in mind, and is expected to reduce time for biomolecular analysis while meeting the highest demands for accuracy, sensitivity and reproducibility. Biacore C combines the advantages of the Company''s non-label Surface Plasmon Resonance (SPR) technology with advanced instrumentation and software to offer an unparalleled level of performance and reliability. The new system is optimized for fully automated concentration analysis with advanced data evaluation and automatic report capabilities. Biacore C Control Software is designed to support the GLP/GMP regulated working processes with built-in validation features for observance of worldwide regulations. Biacore C provides improved quantitative and qualitative concentration determinations that offer: · Real-time data analysis · Wizard based software for assay development and concentration analysis · State-of-the-art validation features · · Low sample usage/ low reagent usage Launched in conjunction with Biacore C is a new customer validation service, which further supports the customer''s efforts to conform to generally accepted GLP/GMP standards. This unique package provides for installation and operational qualification (IQ/OQ) documentation upon system delivery and on-site IQ/OQ performance. A maintenance requalification service is also included to ensure the system is maintained in a validated state. ""Biacore C incorporates the knowledge, experience, engineering and validation skills of Biacore International in expanding and improving QC applications with the highest performance systems available"", commented Fredrik Sundberg, Marketing Manager for Drug Development, QC & Validation, Pharmaceutical and Biotech Business Unit at Biacore. ""We are fully committed to bringing new technologies to market that offer drug discovery and drug development companies advantages in quality, reliability and throughput of data from the early stages of research to the strict regulatory environment of drug manufacturing."" -- Ends -- This press release contains certain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, which, by their nature, involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Notes to Editors: Biacore is a global market leader in Surface Plasmon Resonance (SPR) based technology with its own sales operations in the U.S., across Europe, in Japan, Australia and New Zealand. The technology is protected by a strong patent portfolio. Target groups consist primarily of medical and life science research laboratories and pharmaceutical and biotechnology companies all over the world. Biacore focuses on drug discovery as the prime area for future growth. The Company currently has seven systems on the market with its Biacore®S51 for applications downstream of high-throughput screening (HTS) including rapid characterization of HTS hits and comprehensive preclinical evaluation of lead compounds. Biacore®3000 offers specific applications in drug discovery upstream of HTS. A new SPR array system is currently under development. Based in Uppsala, Sweden, the Company is listed on Stockholmsbörsen and Nasdaq in the U.S. In 2000 the Company had sales of SEK 438.8 million and an operating income of SEK 78.0 million. Further information on Biacore can be found on the web: www.biacore.com Address and phone: Biacore International AB Rapsgatan 7, SE-754 50 Uppsala, SWEDEN Phone: +46 (0)18-675700 Fax: +46 (0)18-150111 info@biacore.com For further information, please contact: Fredrik Sundberg, Biacore AB Marketing Manager Drug Development, QC and Validation Pharmaceutical and Biotechnology Business Unit +46 (0) 18 67 5700 Scientific/Trade Press Enquiries: Michelle Lerner, HCC De Facto Group +44 (0) 207 496 3354 ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2001/09/18/20010918BIT00810/bit0001.doc http://www.waymaker.net/bitonline/2001/09/18/20010918BIT00810/bit0001.pdf