Exhibitor News-Day 2
Court Square Data Group Helps Bridge Gap Between IT and Quality AssuranceCourt Square Data Group, Inc. (Springfield, MA, www.csdg.com) offers organizational management and technology services to help resolve the disconnect between the quality assurance and IT departments in biopharmaceutical firms.
Court Square attributes the bulk of IT compliance problems to a cultural and organizational disconnect between IT and quality assurance and to the fact that few IT departments use operating procedures that are aimed at ensuring compliance. According to company representatives, “the two departments speak different languages,” leading to communication problems and, possibly, failed audits.
Court Square’s goal is to make compliance a predictable outcome for IT, just as it is for quality assurance, and to help the two departments work together effectively.
Emerson Demonstrates Risk-Reduction Tools
Emerson Process Management (Austin, TX, www.emersonprocess.com) featured its portfolio of measurement, analytical, and control solutions at the Interphex2007 Conference and Exhibition. The company set up a “Plant of the Future” for reducing risk, including the company’s “PlantWeb” digital plant architecture as part of a fully integrated system. The system was designed to reduce risk, manufacturing cycle time, and cost. Emerson also offers its “OpX Advantage Program,” which combines consulting and engineering expertise, PlantWeb digital automation technology with Six Sigma and Lean Manufacturing business process improvement methodologies for leveraging the US Food and Drug Administration’s CGMPs for the 21st century initiative.
Hollister-Stier Acquired by JubilantHollister-Stier Laboratories LLC (Spokane, WA, www.hollister-stier.com) announced its acquisition by Jubilant Organosys (Uttar Pradesh, India, www.jubl.net). The total purchase price is $122.5 million.
The acquisition provides Jubilant with a growing contract injectables manufacturing business as well as a stable allergy business. The acquisition is expected to be completed by June 2007.
NextDocs Releases Document Management SystemNextDocs Corporation (Wayne, PA, www.nextdocs.com) is releasing version 2.0 of its Enterprise document management system software suite. The new version adds quality and compliance management products to the company’s product portfolio. Enterprise is 21 CFR Part 11 compliant and is easy to use and rapidly deployable. Enterprise provides process-specific workflows and digital signatures and easily integrates with desktop applications such as Microsoft Office 2007.
Pall Life Sciences Unveils Wide Range of Fluid Management Technologies
Pall Life Sciences (East Hills, NY, www.pall.com) launched several technologies for the biotechnology and vaccine markets. During a press conference, Ian Sellic, marketing director; Ken Frank, president of Pall Biopharmaceuticals and vice-president of Pall Corporation; Helene Pora, marketing director; Xuemin Liu, PhD, marketing manager, and Thomas Scholz, marketing manager, each highlighted the benefits of these technologies.
Pall’s “Allegro” systems, integrated single-use platform includes flexible biocontainers for collection and transport of process solutions, product intermediates, and cell-culture media. “Single-use technologies are used by more than 90% of biopharmaceutical manufacturers,” said Pora. “They increase efficiency by eliminating the need for cleaning and cleaning validation and reduce cross-contamination costs.”
Pall also introduced the industry’s first tangential-flow filtration capsule, its “Kleenpak” TFF microfiltration capsule for clarifying, concentrating, and purifying proteins. The release of Pall’s line of ultrafiltration technologies, “Omega” T-series membrane cassettes-for reducing extractables and ensuring effective mass transfer-and the disposable version, the “Minimate II” capsule, also were announced.