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Should monoclonal antibodies and their conjugates be considered occupational hazards.

Connor-TH; MacKenzie-BA
Safety Considerations in Oncology Pharmacy. Special Edition. Kurt E, Goodman N, eds. Belgium: Pharma Publishing and Media Europe, 2011 Fall; :13-16
Monoclonal antibodies are a novel class of agents that often lack information concerning hazards for healthcare workers. Their large molecular weights would be expected to limit bioavailability and toxic potential. However, actual bioavailability in occupational settings remains uncertain. NIOSH [1] adopted a set of six criteria to identify the characteristics of a hazardous drug, see Table 1. Since each drug is unique and varies considerably in structure, biological activity, bioavailability, formulation, and other characteristics, NIOSH evaluates each drug on an individual basis and not as a member of a specific class. For example, the American Hospital Formulary Service [8] currently lists monoclonal antibodies, including conjugated forms, as one of eight categories of antineoplastic drugs, see Table 2. Because they are proteins in nature, monoclonal antibodies themselves are not required to be evaluated for carcinogenicity or genotoxicity, even if their therapeutic effects are directly mediated by antibody binding to a target antigen. However, monoclonal antibodies may be conjugated to other carcinogenic or genotoxic agents in order to target those toxic agents to specific cell types. For example, gemtuzumab ozogamicin was marketed in the US until 2010 [9]. The monoclonal antibody component of the drug targeted it to CD33, a cell surface antigen found on leukaemic blast cells. The toxic agent to which the antibody was conjugated, a calicheamicin cytotoxic agent, worked by binding to DNA [10]. Given the complex procedures for the preparation of some of the monoclonal antibodies and the requirement for aseptic preparation, many of the same procedures used in the preparation of the drugs identified as hazardous should apply to the preparation of monoclonal antibodies. 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 [1, 19].
Pharmaceuticals; Drugs; Drug-Therapy; Oncogenic-agents; Carcinogens; Health-hazards; Health-care-personnel; Hazardous-materials; Toxic-materials; Bioactivation; Biochemical-analysis; Physiological-response; Molecular-biology; Molecular-structure; Antibody-response; Antineoplastic-agents; Protein-biochemistry; Carcinogenicity; Genotoxicity; Therapeutic-agents; Antigens; Cell-function; Cellular-reactions; Cellular-structures; Medicinal-chemicals
Publication Date
Document Type
Book or book chapter
Kurt-E; Goodman-N
Fiscal Year
NTIS Accession No.
NTIS Price
NIOSH Division
Priority Area
Healthcare and Social Assistance
Source Name
Safety Considerations in Oncology Pharmacy. Special Edition.