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Yesterday, Dr. Sudarsan Rachuri was given the 2016 ASTM International President’s Leadership Award. This recognizes individuals early in their ASTM International career who have significantly advanced the organization's mission through extraordinary accomplishment, example, and vision. Rachuri is serving as Editor-in-Chief of ASTM International’s new journal, Smart and Sustainable Manufacturing…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10176
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With support from industry and government leaders, ASTM International will host an organizational meeting to potentially create a new technical committee that develops voluntary consensus standards for commercial spaceflight. This meeting comes in part as a result of the updated U.S. Commercial Space Launch Competitiveness Act of 2015 (CSLCA). The U.S. Federal Aviation Administration’s…, ASTM Commercial Spaceflight Meeting:, Oct. 24, 2016, RTCA, Inc.; 1150 18th St. NW, 4th Floor, Washington, DC 20036, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #10170
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Today, the U.S. Department of Agriculture selected the Safety Equipment Institute - a subsidiary of ASTM International - to manage the certification program that supports labeling thousands of products as "biobased." The renewal of this five-year contract will mean that more and more people will be able to find and purchase products that are made and packaged using renewable materials. “This…, Program Contact:, Pat Gleason, tel. +1.703.442.5732; pgleason@seinet.org, Media Inquiries:, Dan Bergels, tel. +1.610.832.9602; dbergels@astm.org Release #10160
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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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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 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…
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The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has undergone a change in title and scope that reflects the intent of the committee to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes. The committee is now known as E55…