February 2009

MAb Contaminant Removal with a Multimodal Anion Exchanger

Monoclonal antibodies (MAbs) constitute ∼30% of the biopharmaceutical products currently under development (1). An increasing demand for MAbs during the past decade has led to intense development of high-expression cell cultures (2). Today, it is possible to see titers of 4–5 g/L, and expression levels as high as 15 g/L and greater have been reported. As a consequence, demand has increased for more efficient downstream processes. That demand, combined with its potential for reducing time-to-market, has increased interest in the…

Better Positioned Than Ever

    In June 2007, Sartorius AG acquired the French company, Stedim S.A., and a global solution provider for the biopharmaceutical industry was created. Since then, the new company — Sartorius Stedim Biotech (SSB) — has entered into collaborations with a number of other key industry players, including Metroglas, Bayer Technology Services GmbH and the recently acquired Wave Biotech AG to bring technologies such as single-use bioreactors, UVC irradiation and the first disposable–integrated electrochemical pH sensor into its rapidly expanding…

IBC’s 18th InternationalBiological Assay Development and Valiation

Biological assays continue to be considered the “quality” assay for biopharmaceuticals. Companies often ignore their importance and find themselves on clinical hold in phase 2 — or worse, in phase 3 — because their biological assays do not meet current expectations. (Usually there are performance, robustness, and/or specificity problems.) This is the conference to find out the newest technical, regulatory, and practical trends for the all-important biological assays. IBC’s 18th International Bioassay meeting has it all. Get the tools you…

Disposable pH Sensors

    This paper describes the design, development and validation procedure for a novel, single-use gamma-stable electrochemical pH probe jointly developed by Sartorius Stedim Biotech SA and Metroglas. This new, single-use pH sensor offers a range of pH measurements (from 0 to 11 with ±0.1 precision) and features a one-point calibration process in its storage solution that provides a fast and easy pre- and post-use sensor performance check. Also described is a specific encapsulation device designed to integrate the pH…

Global Marketplace

  Disposable Clamps     Product: 6″ and 8″ BioClamps Applications: Biomanufacturing Features: In addition to the 0.5″ to 4″ family range of disposable BioClamp products, BioPure Technology now offers 6″ and 8″ sizes. They meet the requirements of media transportation for light weight, strength, and easy manipulation. Two wing-nuts provide even compression across the entire circumference for a secure and safe seal, with the added benefit of perforation to facilitate tamper-proof ties. Underside-molded lot numbers ease traceability, and clamps…