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Baxter Healthcare, Merck, Teledyne
AAPS, San Antonio, TX (Oct. 31)-Baxter HealthCare Corporation (Deerfield, ILL, www.baxter.com) is expanding lyophilization capacity at its facility in Halle, Germany, to support future growth of the cytotoxic contract manufacturing business of Baxter BioPharma Solutions (www.baxterbiopharmasolutions.com). Two large-scale lyophilization chambers will be added. The expansion is expected to be completed and validated by mid-2007.
AAPS, San Antonio, TX (Oct. 29)-International Specialty Products (ISP, Wayne, NJ, www.ispcorp.com/) expanded production capacity for “Polyplasdone,” a polyvinylpyrrolidone polymer used as a tablet disintegrant at its facilities in Texas City, Texas. This second manufacturing site is undergoing validation and will begin routine production early next year. The capacity increase is being driven by increased demand for fast-dissolving oral tablets as well as for use in enhancing the solubility of poorly water-soluble actives, explains Tim Bee, ISP's senior director of pharmaceuticals and oral care.
ISP also is opening a new technical service center in Istanbul, Turkey for its “Advantia” coating systems. The product line consists of cellulose-based coating systems for immediate-release and aesthetic applications and acrylate-based coatings for modified-release applications. The opening of the center is set for later this year and provides the company with eight locations in the United States, Europe, Latin America, and Asia for the Advantia product line.
ISP further comments that it is seeing significant increase in new customers seeking its formulation and spray-drying technology used to enhance bioavailability for poorly soluble drugs with several drugs moving into later stage clinical studies. ISP gained the technology through its 2004 acquisition of the pharmaceutical technology business of Niro Inc. (Columbia, MD, www.niroinc.com) and offers the technology at its facilities in Columbia, Maryland. The company offers customized formulation approaches using spray-drying technologies for developmental studies and for clinical trial and commercial manufacture.
AAPS, San Antonio, TX (Oct. 29)-Merck & Co., Inc. (Whitehouse Station, NJ, www.merck.com) released the 14th edition of The Merck Index, a one-volume encyclopedia of chemicals, drugs, and biologicals. The Index contains 2500 pages with 10,200 monographs, each describing a single substance of small groups of related compounds. Also included are chemical and brand names, molecular weights and formulas, citations to scientific literature, depictions of structures, physical and toxicity data, details on commercial and therapeutic uses, and up-to-date regulatory information on carcinogens and controlled substances. The book comes with a companion CD-Rom and a one-year subscription to the online version.
AAPS, San Antonio, TX (Oct. 29)-Palatinit GmbH (Mannheim, Germany, www.palatinit.de) introduced direct-compressible grades of “galenIQ,” an excipient based on hydrogenated isomaltulose. GalenIQ 720 and galen IQ 721 are both agglomerated spherical isomalts used for direct compression applications.
AAPS, San Antonio, TX (Oct. 29)-Teledyne Tekmar (Mason, OH, www.tekmar.com) is offering a pharmaceutical cleaning validation seminar to provide training for using total organic carbon (TOC) for cleaning validation sample analysis. The course details the considerations in selecting TOC as an analytical tool either for first-time cleaning validation or as an alternative analytical method and provides hands-on training in limit calculations, coupon spiking, swabbing techniques, sample analysis on a TOC instrument, and interpretation of results.
AAPS, San Antonio, TX (Oct. 29)-Thermo Electron Corporation (San Jose, CA, www.thermo.com) has extended its protein identification and quantitation software package with the newly designed “BioWorks” 3.3, which enables automated quantitative analysis of “iTRAQ,” “SILAC,” and “ICAT” labeled samples and label-free quantitation techniques.
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