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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 Committee E61 to Maintain and Develop International Standards, ASTM International, one of the largest voluntary standards development organizations in the world, has announced that ASTM Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications has been reorganized as ASTM Committee E61 on Radiation Processing . The new main committee will revise and maintain the existing Subcommittee E10.01 standards and will develop new standards that cover…, ASTM Committee E61 Next Meeting:, Jan. 27-29, 2013, Jacksonville, Fla., ASTM Staff Contact:, Joseph Koury, Phone: 610-832-9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9231
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ASTM International is a recognized resource for snow skiing safety. From technical standard like test methods and specifications to state-of-the-art research, documents offered by ASTM International guide much of the safety measures available in skiing today. A fact sheet on ASTM International and Ski Safety can be found at www.astm.org/skiing . Snow Skiing Standards ASTM International Committee…, Skiing Trauma and Safety, , published in March 2009, features 21 papers written by individuals from many disciplines, all of who are interested in snow sports safety. Some of the papers included are: - Do Helmets Reduce Fatalities or Merely Alter the Patterns of Death?; - Head Kinematics During Experimental Snowboard Falls: Implications for Snow Helmet Standards; - Pediatric Head and Neck Injuries in Snow Sports:…
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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…
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A new ASTM International standard, F 2546 , Test Method for Snowboard Step-in Bindings, will contribute to the safety of snowboarders by describing the steps required to evaluate a step-in snowboard binding-boot system. F 2546 is under the jurisdiction of Subcommittee F27.85 on Snowboarding, which is part of ASTM International Committee F27 on Snow Skiing. “Leading snowboard binding…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control. The scope of the new subcommittee is the development of general principles, practices and related standards for managing…