Maura C. Kibbey is director of science and standards, USP Global Biologics.
First USP Workshop of its Kind Focuses on Particulates in Biologics
Along with particulate control and determination, speakers at the June conference in Rockville, Maryland, examined the role of protein aggregation and immunogenicity
Standards-Setting Activities on Impurities
USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.