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A new ASTM International standard could help pharmaceutical manufacturers support product quality through sampling done with certain instruments. ASTM International’s committee on manufacturing pharmaceutical and biopharmaceutical products ( E55 ) developed the new standard ( E3177 ), which covers both the sample from which data is taken and the sample that is taken for reference. “This standard…, 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 #10650
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A new ASTM International standard will help determine how suitable a gaseous fuel is for use in internal combustion engines in both mobile and stationary applications. ASTM’s committee on gaseous fuels ( D03 ) published the new standard, which will soon be published as D8221. The new standard will be used to determine the calculated methane number (MNc) of gaseous fuels to be used in internal…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Brian Milewski, tel +1.610.832.9619; bmilewski@astm.org Release #10649
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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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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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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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ASTM Subcommittee D03.14 on Hydrogen and Fuel Cells is currently developing the last two of a series of standards designed to support quality standards for hydrogen fuel cell vehicles being developed by SAE International (formerly the Society of Automotive Engineers) and the International Organization for Standardization (ISO). The two standards currently under development are ASTM WK34574 , Test…, ASTM Committee D03 Next Meeting:, Dec. 5-7, 2011, in conjunction with D02 December meeting, New Orleans, La., Technical Contact:, Jacquelyn Birdsall, California Fuel Cell Partnership, West Sacramento, Calif., Phone: 916-375-7421; jbirdsall@cafcp.org, ASTM Staff Contact:, Alyson Fick, Phone: 610-832-9710; afick@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9003