Woods Hole Oceanographic Institution Helium Isotope Laboratory data release no. 1

This report summarizes technique, estimated precisions and results for 3H and 3He analyses made on three cruises in the Sargasso Sea. In addition, a statistical treatment is made on 36 surface (≤10m) 3He/4He analyses to obtain an estimate of the solubility isotope effect and its temperature dependence to be ( α - 1) X 1000 °/oo = -(17.3 ~ 0.8) +(0.28 ~ 0.06) T (°C) with a regression scatter of 2.6 °/oo and a linear correlation coefficient of 0.640.Prepared for the Office of Naval Research under Contract N00014-74-C-0262; NR 083-004 and for the National Science Foundation under Grant OCE 76-20485

Current Technologies to Endotoxin Detection and Removal for Biopharmaceutical Purification

Endotoxins are the major contributors to the pyrogenic response caused by contaminated pharmaceutical products, formulation ingredients, and medical devices. Recombinant biopharmaceutical products are manufactured using living organisms, including Gram-negative bacteria. Upon the death of a Gram-negative bacterium, endotoxins (also known as lipopolysaccharides) in the outer cell membrane are released into the lysate where they can interact with and form bonds with biomolecules, including target therapeutic compounds. Endotoxin contamination of biologic products may also occur through water, raw materials such as excipients, media, additives, sera, equipment, containers closure systems, and expression systems used in manufacturing. The manufacturing process is, therefore, in critical need of methods to reduce and remove endotoxins by monitoring raw materials and in-process intermediates at critical steps, in addition to final drug product release testing. This review paper highlights a discussion on three major topics about endotoxin detection techniques, upstream processes for the production of therapeutic molecules, and downstream processes to eliminate endotoxins during product purification. Finally, we have evaluated the effectiveness of endotoxin removal processes from a perspective of high purity and low cost