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Standard to specify process for manufacturing viral kill step.

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July 11, 2012 - 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 International Committee E55 on Manufacture of Pharmaceutical Products. Standard will provide important process step to be used in manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactive retroviruses.

ASTM Pharmaceutical Committee Developing Proposed Standard to Specify the Process for a Manufacturing Viral Kill Step


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ASTM International
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Press release date: June 28, 2012

W. CONSHOHOCKEN, Pa., -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 International Committee E55 on Manufacture of Pharmaceutical Products.

"The biopharmaceutical industry has been doing viral inactivation and viral kill studies for many years and has been doing small scale validation studies for at least 25 years," says Robert Steininger, senior vice president, process development and manufacturing, Acceleron Pharmaceuticals, and chair of E55.04. "During this time, many companies have generated data showing that low pH will consistently inactivate retroviruses. The hope is that the industry could take advantage of this data and create a standard that, if followed, would give a high level of assurance that potential retroviruses would be inactivated and would avoid the repetitive viral validation work which is currently done."

Steininger says that, once it has been approved, ASTM WK36552 will be used by companies developing new protein-based drugs using mammalian cells. "These biotechnology drugs are particularly important in the industry now," says Steininger.

Interested parties, especially those from the biotechnology community, are invited to join in the ongoing standards development work of E55.04.

ASTM International welcomes participation in the development of its standards. For more information on becoming an ASTM member, visit www.astm.org/JOIN.

ASTM International is one of the largest international standards development and delivery systems in the world. ASTM International meets the World Trade Organization (WTO) principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance and transparency. ASTM standards are accepted and used in research and development, product testing, quality systems and commercial transactions.

For more news in this sector, visit www.astm.org/sn-medical or follow us on Twitter @ASTMMedical.

ASTM Committee E55 Next Meeting: Sept. 19-20, 2012, GlaxoSmithKline, Collegeville, Pa. Technical Contact: Robert Steininger, Acceleron Pharmaceuticals, Cambridge, Mass., Phone: 617-649-9288; bsteininger@acceleronphrarma.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
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