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Favrille Selects Camstar's MES For the Manufacture of Personalized Medicines in the Biotech Industry; Electronic Batch Records Critical as Biopharmaceutical Company Moves Toward Commercialization of its Lead Product Candidate.


CHARLOTTE, N.C. -- Camstar, the leading provider of enterprise manufacturing execution and quality management solutions, announced today that Favrille, a biopharmaceutical company developing patient-specific cancer immunotherapies, has selected Camstar's manufacturing execution system

Manufacturing execution system (MES) describes a set of integrated functions within a packaged software system or it can also describe the accumulated functionality within the production management infrastructure of a manufacturing or production company.
 (MES (Manufacturing Execution Software) Software that provides real time access to plant activities that include equipment, labor, orders and inventory. An MES integrates the data with enterprise resource planning (ERP) systems so that management has complete control of ), InSite, to replace the company's current paper-driven batch records to streamline processes.

Favrille is currently in Phase III clinical trials for FavId(R), an active immunotherapy active immunotherapy The administration of substances to evoke a protective immune response in the form of specific antibodies. Cf Passive immunotherapy, Vaccine.  for the treatment of follicular fol·lic·u·lar
adj.
1. Relating to, having, or resembling a follicle or follicles.

2. Affecting or growing out of a follicle or follicles.
 B-cell non-Hodgkin's lymphoma. As the company moves toward commercialization of this product, it is focusing on the implementation of Electronic Batch Records to help scale manufacturing efforts.

"Commercializing a patient-specific immunotherapy product like FavId requires a manufacturing process with an extensive paper batch record," said Tamara A. Seymour, Favrille's Chief Financial Officer. "Camstar's MES solution will replace our paper batch record with an Electronic Batch Record that can streamline the collection and management of manufacturing data. Camstar's advanced technology platform is ideal for handling processes and calculations that are necessary in producing a therapy based on each patient's unique genetic information."

Camstar's InSite will provide Favrille with real-time production information with full traceability and control. The solution will be tightly integrated into an IT environment that consists of ERP (Enterprise Resource Planning) An integrated information system that serves all departments within an enterprise. Evolving out of the manufacturing industry, ERP implies the use of packaged software rather than proprietary software written by or for one customer. , Electronic Document Management (EDM (Engineering Data Management) An information system that maintains the details of all engineering data while the product is in the design and concept phase. This includes geometry and changes to geometry. See PLM.

EDM - Electronic Data Management
), and various instrumentation and data collection devices. IBM (International Business Machines Corporation, Armonk, NY, www.ibm.com) The world's largest computer company. IBM's product lines include the S/390 mainframes (zSeries), AS/400 midrange business systems (iSeries), RS/6000 workstations and servers (pSeries), Intel-based servers (xSeries)  Business Services, a Camstar Systems Integration partner, will lead the implementation effort.

"Camstar's integration with core systems such as ERP and EDM is vital as it ensures that all of our data is current and consistent," said Brad Phillips, Favrille's Senior Director of Information Technology. "Because Camstar partners with IBM Business Services, we have a single, experienced point-of-contact to manage the entire implementation process."

"We are very pleased to be working with Favrille and IBM Business Services," said Rob Rudder, Camstar's Vice President of Sales and Marketing. "Camstar's solutions offer extensive configurability and interoperability, which make them a perfect fit for Biotech companies looking to rapidly commercialize and distribute their products with minimum risk."

About Camstar Systems, Inc.

Camstar is a leading provider of enterprise Manufacturing Execution and Quality Systems. Camstar's InSite and Medical Device Suite applications manage, monitor, and synchronize manufacturing activities across globally distributed plants, and integrates them in real-time with core business processes. Rapid to implement, they provide the manufacturing control needed to help eliminate scrap, rework, paperwork errors and redundant checks. As a result, manufacturers improve yields and product quality, shorten lead times and reach volumes quickly, respond to changing demand, and reduce the cost of compliance. More than 100 leading companies, including Johnson & Johnson, Roche, Tyco, ZOLL, CIBA Vision, Zeiss, Kinetic Concepts, BIOTRONIK, IBM, Kodak, AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. , Philips, Hitachi, SCHOTT, Amkor, ASAT ASAT
abbr.
antisatellite

Adj. 1. ASAT - of or relating to a system to destroy satellites in orbit; "antisatellite weapons"
antisatellite
, Renesas, Arcelor and Industeel rely on Camstar as a trusted software partner.

For more information, please visit www.camstar.com.

About Favrille

Favrille, Inc. is a biopharmaceutical company focused on the development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system. The Company's lead product candidate, FavId, is based upon unique genetic information extracted from a patient's tumor. FavId is currently under investigation in a pivotal Phase III clinical trial for patients with follicular B-cell NHL NHL Non-Hodgkin's lymphoma, see there  and Phase 2 clinical trials in other B-cell NHL indications. The Company is developing additional applications based on its immunotherapy expertise and proprietary cost-effective manufacturing technology, including a second product candidate, FAV-201, for the treatment of cutaneous T-cell lymphoma Cutaneous T-Cell Lymphoma Definition

Cutaneous T-cell lymphoma (CTCL) is a malignancy of the T-helper (CD4+) cells of the immune system.
Description
.

For more information, please visit www.favrille.com.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Aug 3, 2006
Words:562
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