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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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Low frequency radio frequency identification transponders have become a common means of acquiring data at livestock collection points, such as markets, feed yards and packing plants. However, there are currently multiple LF RFID technologies that exist in the marketplace, the LF RFID Half Duplex and LF RFID Full Duplex technologies. In response, ASTM International Committee F10 on Livestock, Meat…, ASTM Committee F10 Next Meeting:, April 18-19, 2012, April Committee Week, Phoenix, Ariz., Technical Contact:, Bryan Rickard, Micro Beef Technologies Ltd., Amarillo, Texas, Phone: 806-372-2369; brickard@microbeef.com, ASTM Staff Contact:, Kelly Paul, Phone: 610-832-9745; kpaul@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9136
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The term “tender” is often used by the animal agriculture and meat industries to describe finished meat products that impart a more enjoyable eating experience. It is an attribute that is sought after by consumers and with appropriate marketing strategies can command a premium in the marketplace. However, can a consumer know for certain what “tender” means? A new ASTM International standard…, ASTM Committee F10 Next Meeting:, April 18-19, 2012, April Committee Week, Phoenix, Ariz., Technical Contact:, Martin E. O’Connor, U.S. Department of Agriculture, Washington, D.C., Phone: 202-720-7046; martin.oconnor@ams.usda.gov, ASTM Staff Contact:, Kelly Paul, Phone: 610-832-9745; kpaul@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9020
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Being able to complement marketing claims in advertising and promotions with third-party certification or verification is important in any industry. A new ASTM subcommittee will be working on standards for such verification in the livestock and meat industry. The new subcommittee, F10.60 on Livestock, Meat and Poultry Marketing Claims, is part of ASTM International Committee F10 on Livestock,…
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There has been a renewed interest in instrumental qualification and standardization by the fluorescence community over the last 10 years, driven by the increasing number of quantitative chemical assays that use fluorescence detection and the presence of regulations in some of these areas. After revising three test methods for fluorescence instruments, stakeholders decided that a standard guide…
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ASTM Committee F10 on Livestock, Meat and Poultry Evaluation Systems has approved a new standard, F2717 , Guide for the Development of Independent Third-Party Verification. The standard, which was developed by Subcommittee F10.20 on Device Performance Criteria, provides an internationally recognized set of guidelines for companies that test the accuracy of livestock, meat and poultry evaluation…
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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…