Particulates in biotechnology products

BIOT 131

Subramanian Muthukkumar, Subramanian.Muthukkumar@fda.hhs.gov, Div Monoclonal Antibodies, FDA/CDER, 29 Lincoln Dr, Bethesda, MD 20892
Injectable solutions intended for parenteral use should be essentially free from visible particulates and subvisible particles should be within specific size ranges (USP<788>). Sub-visible particulates are measured using Light obscuration method or Microscopic method. Our experience with particulates in reviewing monoclonal antibody products will be discussed.
 

FDA Symposium: Process Development and Validation
8:00 AM-11:20 AM, Tuesday, 12 September 2006 Hilton San Francisco -- Imperial A Ballroom, Oral

Division of Biochemical Technology

The 232nd ACS National Meeting, San Francisco, CA, September 10-14, 2006