Standardization News

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.

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 Pharma, and chairman 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, 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, particularly from the biotechnology community, are invited to join in the ongoing standards development work of E55.04.

"The biotechnology community has been working for 30 years on process development and assay development for the production of protein drugs," says Steininger. "During this time, the industry has created an extensive set of knowledge that can be tapped to create helpful standards for the industry so that methods and process steps don't have to be developed each time for the more typical drugs, particularly those related to monoclonal antibodies and their derivatives."

CONTACT Technical Information: Robert Steininger, Acceleron Pharma • Cambridge, Mass. • Phone: 617-649-9288 | ASTM Staff: Christine DeJong • Phone: 610-832-9736 | Upcoming Meeting: Sept. 19-20, Collegeville, Pa.