Customer Corner
XOMA Deploys SQL*LIMS Micro/EM to Automate Critical Monitoring Processes
XOMA Ltd, a leader in the discovery, development and manufacture of therapeutic antibodies, has deployed SQL*LIMS Micro/EM™ to automate environmental and utility monitoring processes at their biologics manufacturing facilities in Berkeley, CA.
SQL*LIMS Micro/EM is a revolutionary new solution that combines paperless, mobile data acquisition with unparalleled data visualization and analysis capabilities. It is the result of a partnership between Applied Biosystems and MODA Technology Partners (MODA) to expand the SQL*LIMS® product line with capabilities and functionality important to our customers.
“Environmental and utility monitoring are a critical part of our QC program,” explains Ric Reordan, XOMA’s Manager of Microbiology. “As part of our manufacturing activities, we are required to provide a contaminant free environment for the production of a wide range of therapeutic products. With SQL*LIMS Micro/EM, we have transformed our environmental and utility monitoring program to a paperless operation. Improvements in productivity and compliance enable my team to focus on high value science-based activity rather than administrative paperwork. And ultimately this enhances XOMA’s manufacturing operations.”
XOMA has extensive experience manufacturing biologics for its proprietary and partnered product programs. XOMA’s quality and operational infrastructure enables the manufacture of product candidates through every phase of product development in compliance with cGMP using mammalian and microbial systems.
“The SQL*LIMS Micro/EM package enabled us to achieve certain efficiencies,” adds Frank Bernard, XOMA’s Senior IT Manager. “We were able to go into production within four months versus an alternative of 18 months for a solution requiring customization. Support and administration are greatly simplified with a single, unified platform for QA and QC users. And our user community loves the functionality and efficiencies gained in their processes.”
To develop and deliver SQL*LIMS Micro/EM, Applied Biosystems partnered with MODA Technology Partners, a software company that provides mobile data acquisition solutions to the pharmaceutical manufacturing industry. MODA products power SQL*LIMS Micro/EM, delivering an integrated solution for quality assurance and quality control, and help ensure that a first class environmental monitoring program is maintained for all of XOMA’s extensive manufacturing processes.
Worrying about the logistics of data acquisition and accuracy in a clean room environment should be the least of the issues addressed by biologics manufacturing facilities. The integrated SQL*LIMS Micro/EM solution enhances operations while keeping work activities streamlined, and thus enables manufacturing facilities to stay focused on the work at hand.
About XOMA
A leader in the discovery, development and manufacture of therapeutic antibodies, XOMA Ltd’s expanding pipeline includes XOMA 052, an anti-IL-1 beta antibody, and XOMA 629, a synthetic peptide compound derived from bactericidal/permeability-increasing protein.
XOMA's proprietary development pipeline is primarily funded by multiple revenue streams resulting from the licensing of its antibody technologies, product royalties, development collaborations, and biodefense contracts. XOMA's technologies and experienced team have contributed to the success of marketed antibody products, including RAPTIVA® (efalizumab) for chronic moderate to severe plaque psoriasis and LUCENTIS® (ranibizumab injection) for wet age-related macular degeneration.
The Company has a premier antibody discovery and development platform that incorporates leading antibody phage display libraries and XOMA's proprietary Human Engineering(tm) and bacterial cell expression (BCE) technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, more than 50 pharmaceutical and biotechnology companies have signed BCE licenses.
In addition to developing its own products, XOMA develops products for premier pharmaceutical companies including Novartis AG, Schering-Plough Research Institute and Takeda Pharmaceutical Company Limited. XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to product launch, and a team of 300 employees at its Berkeley location. For more information, please visit www.xoma.com.
About MODA Technology Partners
MODA Technology Partners (MODA) is a commercial software company whose primary focus is addressing the growing need for effective automation and efficient regulatory compliance within pharmaceutical manufacturing. MODA's software leverages mobile computing technology to help their clients increase operational efficiency, improve quality and reduce manufacturing costs. Additional information is available at www.modatp.com.
