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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 newly approved ASTM copper standard focuses on the mechanical properties of machining brasses. ASTM B981/B981M , Specification for Low Leaded Brass Rod, Bar and Shapes, was developed by Subcommittee B05.02 on Rod, Bar, Wire, Shapes and Forgings , part of ASTM International Committee B05 on Copper and Copper Alloys . “Since 1997, there has been increasing legislation, regulation and voluntary…, ASTM Committee B05 Next Meeting:, April 15-17, 2013, April Committee Week, Indianapolis, Ind., Technical Contact:, Larry Muller, Chase Brass and Copper Co., Montpelier, Ohio, Phone: 419-485-8932; lmuller@chasebrass.com, ASTM Staff Contact:, Jennifer Rodgers, Phone: 610-832-9694; jrodgers@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9307
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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 International Committee E13 on Molecular Spectroscopy and Separation Science invites all interested parties to join in the ongoing revision of ASTM E1578 , Guide for Laboratory Information Management Systems (LIMS). ASTM E1578 is under the jurisdiction of Subcommittee E13.15 on Analytical Data . According to James B. Powers Jr., managing partner, Bridge Associates LLC, and chair of the E13.…
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All interested parties, particularly end users from the forensics sciences, are encouraged to join in the development of a proposed new ASTM standard, WK18814 , Guide for Relative Intensity Correction of Raman Spectrometers. WK18814 is being developed by Subcommittee E13.08 on Raman Spectroscopy, which is under the jurisdiction of ASTM International Committee E13 on Molecular Spectroscopy and…
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Since the early 1980s, multivariate analytical techniques have been increasingly used in a variety of industries. A new ASTM International standard, E2617 , Practice for Validation of Empirically Derived Multivariate Calibrations, answers a need for standards for these techniques. Subcommittee E13.11 on Multivariate Analysis, under the jurisdiction of ASTM International Committee E13 on Molecular…
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ASTM International Committee B05 on Copper and Copper Alloys has created a new task group, TG9018, which will be focused on the Antimicrobial Applications of Copper and Copper Alloys. The task group was formed following the U.S. Environmental Protection Agency's announcement of its registration of copper alloys as antimicrobial materials with specific health claims. According to James Michel,…
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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…