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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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A proposed ASTM International standard will help businesses, governments, and others who seek the provision of quality, professional language services. The proposed standard (WK41374, Practice for Language Service Companies) is being developed by ASTM International’s committee on language services and products ( F43 ). “Language services are a critical component to global communication and…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Susan Amarino, Liasion Multilingual Services, Inc., Denver, Colo., tel +1.303.762.0997; susan@emultilingual.com, ASTM Staff Contact:, Ashley Wiand, tel +1.610.832.9551; awiand@astm.org Release #10253
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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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A recently revised ASTM International standard aims to help interpreters and their clients better understand the importance of proper language interpretation. F2089 , Practice for Language Interpreting, defines the minimum professional standard for quality services in language interpreting and is intended to be used by purchasers and providers with varying levels of expertise in interpreting. “…, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Monique Roske, M2 Language Consultants LLC, Alexandria, Va., tel +1.703.362.5344; monique@roske.us , ASTM Staff Contact:, Ashley Wiand, tel +1.610.832.9551; awiand@astm.org Release #9899
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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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Translation, Interpretation, Proficiency and Foreign Language Instruction to Be Addressed Newly formed ASTM International Committee F43 on Foreign Language Services and Products will develop standards that promote best practices for users and providers of language services and products. The new standards development group will also serve as a resource on language translation and proficiency for…
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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…