Standard Supports Drug Development



Drug manufacturers will be able to use a new ASTM International nanotechnology standard to help ensure quality control when developing drugs, including some that have the potential to be less toxic and more targeted. ASTM International’s nanotechnology committee (E56) created the new standard (E3143).

“Nanotechnology offers great promise for new drugs to treat a wide variety of illnesses,” says ASTM International member Debra Kaiser, senior advisor, office of data and informatics, National Institute of Standards and Technology.  “This standard will be used to advance the development of liposome nanomaterials, the largest class of nanomaterial-based drug products.

Kaiser explains that the new standard provides a recipe for determining the structure of a liposome nanomaterial. Liposome sacs are used as drug carriers that reduce toxicity and change the way the drug is distributed in the body.

According to Kaiser, using the new standard will reduce the documentation needed when a manufacturer submits a potential new product to a regulatory body, such as the U.S. Food and Drug Administration, which may reduce review time for the submission.    

The committee welcomes participation in the development of its standards. Kaiser notes that the committee is planning new standards that help quantify the composition of liposomal drug formulations by various methods and in vitro immunotoxicology assays. Become a member of ASTM. The next meeting of ASTM International’s nanotechnology committee is May 13-14 in Denver, Colorado, USA.

To purchase standards, contact ASTM International customer relations (tel +1.877.909.ASTM; sales@astm.org).

Industry Sectors: 
Medical
Quality
Issue Month: 
May/June
Issue Year: 
2019