Bio-manufacturer Xoma has deployed SQL*LIMS Micro/EM to automate environmental and utility monitoring and processes at their biologics manufacturing facilities in Berkeley, CA.
Xoma, which develops antibody therapeutics, has experience of manufacturing biologics for its proprietary and partnered product programmes. 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.
Ric Reordan, Xoma's manager of Microbiology, said: ‘Environmental and utility monitoring are a critical part of our QC program. 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.‘
Reordan added: ‘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.’
Applied Biosystems has also partnered with Moda Technology Partners to expand the SQL*LIMS product line with SQL*LIMS Micro/EM, which combines paperless, mobile data acquisition with data visualisation and analysis capabilities, and Xoma has signed up for this product too.
Frank Bernard, Xoma's senior IT manager, said: ‘The SQL*LIMS Micro/EM package enabled us to achieve certain efficiencies. We were able to go into production within four months versus an alternative of eighteen months for a solution requiring customisation. 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.’