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A proposed ASTM International standard aims to promote a shared understanding of the science and engineering behind pharmaceutical freeze-drying. The proposed standard ( WK63507 ) is being developed by ASTM’s committee on the manufacture of pharmaceutical and biopharmaceutical products ( E55 ). According to ASTM member Arnab Ganguly, uncertainty over the best practices in these areas of freeze-…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #10571
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A new ASTM International subcommittee will focus on the process of lyophilization, often referred to as freeze-drying, in the pharmaceutical industry. The group (E55.05) will be part of the committee on pharmaceutical and biopharmaceutical products (E55). The Advanced Lyophilization Technology Hub (LyoHub), a group of manufacturers, researchers, and others in the pharmaceutical and food…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #10500
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Yesterday, ASTM International and NCSL International, two global organizations whose members share an interest in metrology, signed a memorandum of understanding. Metrology, the science of measurement, is a field that cuts across many industries represented by ASTM International’s 145 technical committees. The MOU was signed at ASTM International’s global headquarters during the meeting of its…
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A new ASTM International subcommittee on reliability (E11.40) is developing a standard (WK58249, Guide for Reliability) that will support reliability and risk analysis. The new subcommittee is part of ASTM International’s committee on quality and statistics ( E11 ). “Reliability means quality over time, and many industries need reliability estimates and analysis of materials, components, and…, ASTM Committee E11 on Quality and Statistics Next Meeting:, April 19-21, 2017, ASTM International Headquarters, West Conshohocken, Pa., Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Stephen N. Luko, UTC Aerospace Systems, Windsor Locks, Conn., tel +1.860.654.3447; stephen.luko@hs.utc.com, ASTM Staff Contact:, Katerina Koperna, tel +1.610.832.9728; kkoperna@astm.org R elease #10298
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Pending approval from its board of directors, ASTM International announced yesterday the launch of a new committee focused on creating technical standards and guidance materials for cannabis and its products and processes. Yesterday, about 60 industry representatives, associations, and others convened at ASTM International’s global headquarters near Philadelphia and decided to create a volunteer…, Media Inquiries:, Nate Osburn, tel +1.610.832.9603; nosburn@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10266
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By request from industry, ASTM International will host an organizational meeting to potentially create a new technical committee that develops voluntary consensus standards for cannabis. The no-fee meeting is Tuesday, Feb. 28, at 9 a.m. EST at ASTM International’s global headquarters in, West Conshohocken, Pa., USA. Industry stakeholders and others interested in charting a path towards voluntary…, ASTM Cannabis Organizational Meeting:, Feb. 28, 2017, ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA, 19428-2959 USA, Media Inquiries:, Nate Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #10251
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ASTM International and the Parenteral Drug Association recently signed a Memorandum of Understanding that launches a pilot to streamline efforts and conserve resources as both organizations develop technical guidance for the pharmaceutical industry. Katharine Morgan, executive vice president, ASTM, and Richard M. Johnson, president, PDA, signed the MOU. “The MOU between ASTM International and PDA…, ASTM Committee E55 on Manufacture of Pharmaceutical Products Next Meeting:, April 28-30, 2015, Lisbon, Portugal, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #9815 ###
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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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ASTM International Committee E11 on Quality and Statistics has approved the last in a series of ASTM standards that preserve military sampling standards that were originally under the jurisdiction of the U.S. Department of Defense. The new standard, ASTM E2910 , Guide for Preferred Methods for Acceptance of Product, preserves MIL-STD-1916 in its original form. ASTM E2910 is under the jurisdiction…, ASTM Committee E11 Next Meeting:, May 8-10, 2013, ASTM International Headquarters, West Conshohocken, Pa., Technical Contact:, Dean V. Neubauer, Corning, Inc., Corning, N.Y., Phone: 607-974-6777; neubauerdv@corning.com, ASTM Staff Contact:, Katerina Koperna, Phone: 610-832-9728; kkoperna@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9317
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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…