Standardization News

ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document process steps that can reproducibly inactivate or remove any potential retrovirus in new biologic products, particularly antibodies and antibody-like compounds. 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 has 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 of E55.04.

Primary users of WK39883 will be companies making new biologics that are destined for clinical trials.

John Schreffler, Ph.D., senior scientist, biochemistry development, Morphotek Inc., and an E55 member, 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 are encouraged to participate in the development of WK39883.

CONTACT Technical Information: John Schreffler, Ph.D., Morphotek Inc. • Exton, Pa. • Phone: 610-423-6557 | ASTM Staff: Christine DeJong • Phone: 610-832-9736 | Upcoming Meeting: April 9-11 • Haverhill, Suffolk, United Kingdom