Monoclonal Antibodies

Monoclonal antibodies (mAbs) are laboratory engineered immunoglobulin proteins with very specific cell binding properties. They are produced by cloning numerous identical cells from a single parent cell. These antibodies have numerous applications in the field of diagnostics, therapeutics and targeted drug delivery systems, including cancer, metabolic and hormonal disorders.

There is little information about occupational health and safety exposure risks associated with mAbs because they either do not fulfill hazardous drugs criteria or lack sufficient agent-specific information to assign an appropriate hazard classification.

Given the complex procedures for the preparation of some monoclonal antibodies and the requirement for aseptic preparation, many of the same methods used in the preparation of drugs identified as hazardous should apply to the development of mAbs. Preparation should be performed in a biological safety cabinet or an aseptic compounding isolator using proper procedures and personal protective equipment. Following these procedures will protect both the integrity of the monoclonal antibody and the health of the worker.