Receive industry and products news from the market categories that matter to you most.
Stay up to date on industry news and trends, product announcements and the latest innovations.
Proposed Standard addresses inactivation of enveloped viruses.
Press Release Summary:
Mar 13, 2013 - ASTM International Committee E55 on Manufacture of Pharmaceutical Products is developing proposed standard that will document set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. Once approved, ASTM WK39883, Practice for Process of Inactivation of Enveloped Viruses Using Detergent, will benefit producers of biological drug substances and their patients.
Original Press Release
Proposed Standard for Inactivation of Enveloped Viruses Being Developed by ASTM Pharmaceutical Committee
Press release date: Mar 04, 2013
The proposed standard, ASTM WK39883, Practice for Process of Inactivation of Enveloped Viruses Using Detergent, is under the jurisdiction of Subcommittee E55.04 on General Biopharmaceutical Standards.
“Having a set of standard steps that have been shown through multiple years of use within the industry to substantially reduce the risk related to retrovirus and using those steps during the purification process allows one to feel more confident in the use of developing drugs in clinical trials,” says Robert Steininger, chairman, E55.04.
Once it has been approved, ASTM WK39883 will benefit the producers of biological drug substances and their patients by providing parameters that assure consistent enveloped virus inactivation.
John Schreffler, senior scientist, biochemistry development, Morphotek, and an E55 member who is leading the task group on ASTM WK39883, says that an additional benefit of the proposed standard is a reduction in the cost of viral clearance and inactivation testing for biopharmaceutical drugs in early phase development. “This can allow biopharmaceutical companies to focus their spending and efforts on needed areas of development or even help to reduce the overall cost of bringing a biological drug to the commercial market,” says Schreffler.
All interested parties, particularly those involved with biologics, blood fractionation products and vaccines, are encouraged to participate in the development of ASTM WK39883.
To purchase ASTM standards, visit www.astm.org and search by the standard designation, or contact ASTM Customer Relations (phone: 877-909-ASTM; email@example.com). 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: 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; firstname.lastname@example.org
ASTM Staff Contact: Christine DeJong, Phone: 610-832-9736; email@example.com
ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603; firstname.lastname@example.org
Don't miss the latest news!