Biologic products come in many forms for many applications. There are classical biologics such as antiserum, anti-venoms, and vaccines. Newer applications include therapeutic monoclonal antibodies, cell therapies, and gene therapies. This presentation describes the various biologic medical products, their raw materials, their regulatory position, and testing each for the presence of contaminating endotoxin. Also covered is how to overcome testing interferences, and the special case of “Low Endotoxin Recovery” or LER, when testing certain biologic products.
June 22 | 9:00 am