Press Releases
Electronic Batch Records Critical as Biopharmaceutical Company Moves Toward Commercialization
of its Lead Product Candidate
CHARLOTTE, N.C. (August 3, 2006) - 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 (MES), InSite,
to replace the company’s current paper-driven batch records to streamline processes.
Favrille is currently in Phase III clinical trials for FavId®, an active immunotherapy
for the treatment of follicular 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, Electronic Document Management (EDM), and various
instrumentation and data collection devices. IBM 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 Medical Device Suite application manages, monitors, and synchronizes
manufacturing activities across globally distributed plants, and integrates them
in real-time with core business processes. Rapid to implement, it provides 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, CIBA
Vision, ZOLL, Zeiss, BIOTRONIK, Kinetic Concepts, IBM, Kodak, AMD, Philips and Hitachi
rely on Camstar as a trusted software partner.
For more information about Camstar and its InSite product solutions, call (704)
227-6600 or (800) 588-0030 or visit www.camstar.com.
About Favrille Inc.
Favrille, 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 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. For more information, please visit www.favrille.com.
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