July 2010

Detection of Microbial Contaminants in Water Samples Using the Milliflex® Quantum System

          Water is a key raw material used in manufacturing products within the healthcare, pharmaceutical, and biopharmaceutical industries. Microorganisms found in these water systems are mainly stressed, slow-growing strains characterized by long incubation times (five to seven days) before growth can be detected using traditional microbiology methods such as membrane filtration or pour plates. That time required before contamination can be detected in water can cause delays in product release and extend the storage time of…

Products and Services Designed to Facilitate Cell Culture Media Development

In response to the biopharmaceutical market needs, the focus of Irvine Scientific today is to provide chemically defined and animal-derived component-free cell culture media for use in the production of recombinant proteins. Drug development companies that do not invest in the costly and complex work of media development can rely on the services of Irvine Scientific to obtain and optimize formulas for their production cell lines. As the leader in rapid turn-around time for providing specially formulated products to clients,…

The Waters ACQUITY UPLC H-Class Bio System

          The complete characterization and analysis of biopharmaceuticals includes the application of size- exclusion chromatography (SEC) to measure protein aggregates and other size variants. Soluble protein aggregates in particular can contribute to immunogenicity. Accurate analysis and quantitation of biotherapeutic protein aggregates is therefore often required. Current HPLC/silica-based SEC methods can be time- consuming and unreliable. Their uncertain results may be due to changes in retention time, peak shape, or spacing between peaks as well as irreproducibility…