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ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
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A continuing interest among road authorities to improve highway safety has led to efforts to improve wet-night visibility of pavement markings, including a new ASTM International standard. ASTM E2832 , Test Method for Measuring the Coefficient of Retroreflected Luminance of Pavement Markings in a Standard Condition of Continuous Wetting (RL-2), was developed by Subcommittee E12.10 on…, ASTM Committee E12 Next Meeting:, Jan. 30-31, 2013, January committee week, Jacksonville, Fla., Technical Contact:, Paul Carlson, Texas Transportation Institute, College Station, Texas, Phone: 979-845-6004; paul-carlson@tamu.edu, ASTM Staff Contact:, Thomas O’Toole, Phone: 610-832-9739; totoole@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9243
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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…
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Users of standards involving kinetic parameters need reference materials to qualify individual laboratories and to validate procedures and software. A new ASTM International standard will provide such parameters to accommodate apparatus configurations and kinetic models. ASTM E2781 , Practice for Evaluation of Methods for Determination of Kinetic Parameters by Thermal Analysis, was developed by…, ASTM Committee E27 Next Meeting:, Nov. 15-17, November Committee Week, Tampa, Fla., Technical Contact:, Roger Blaine, Corvallis, Ore., Phone:, 302-559-6827; roger.l.blaine@gmail.com ASTM Staff Contact:, Scott Orthey, Phone: 610-832-9730; sorthey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8893
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Proposed ASTM Kinetic Parameters Standard Being Developed by Hazard Potential of Chemicals CommitteeA proposed new standard being developed by ASTM International Committee E27 on Hazard Potential of Chemicals will provide needed reference materials for instruments, applications and software used for the evaluation of kinetic data used for hazard evaluation. The proposed new standard, ASTM WK27880 , Practice for Evaluation of Methods for Determination of Kinetic Parameters by Thermal Analysis,…, ASTM Committee E27 Next Meeting:, Nov. 15-17, November Committee Week, Tampa, Fla., Technical Contact:, Roger Blaine, Corvallis, Ore., Phone: 302-559-6827; roger.l.blaine@gmail.com, ASTM Staff Contact:, Scott Orthey, Phone: 610-832-9730; sorthey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8611
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A request from the United States Navy was the impetus behind the development of a new ASTM International standard, E2630 , Test Method for Luminance Ratio of a Fluorescent Specimen Using a Narrow Band Source. The new standard was developed by Subcommittee E12.05 on Fluorescence, part of ASTM International Committee E12 on Color and Appearance. Richard Harold, consultant, Color and Appearance…
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First generation gonioapparent colorants are materials pigmented with metal flakes that change lightness as illumination angles change. Used heavily in automotive coatings, the first generation of gonioapparent materials was covered by ASTM International standard E2194 , Practice for Multiangle Color Measurement of Metal Flake Pigmented Materials, first published in 2003. Now, a second generation…
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While the continuous quality verification concept is still quite new, it has the potential to become an important approach to assuring product quality in the pharmaceutical industry. With this in mind, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has approved a new standard, E2537 , Guide for Application of Continuous Quality Verification to Pharmaceutical and…
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ASTM International Committee E12 on Color and Appearance has approved a new standard that describes techniques for planning and analyzing the results of an interlaboratory study conducted for certain test methods within E12. E 2480 , Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method with Multi-Valued Measurands, is under the jurisdiction of Subcommittee…
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products has developed a new standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard, E 2500 , Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, is under the jurisdiction of Subcommittee E55.03 on…