A comprehensive programme required to proactively establish that antibody-drug conjugate (ADC) materials are handled safely and that employees are properly protected from exposure should include the following:
- Employee selection
- Employee training
- Work practices, process designs and engineering controls
- Personal protective equipment (PPE)
- Cleaning and waste disposal (routine)
- Spill response (emergency)
- Industrial hygiene monitoring
- Medical surveillance (including reproductive and developmental issues)
- Record keeping
- Transportation
Written procedures for handling payloads, payload-linkers and ADCs should be established for each unit operation including specific information on the appropriate precautions and controls for each activity. In addition, the process designs for each facility handling payloads and ADCs should include effective strategies for process containment and enclosure, ventilation and PPE to assure worker protection. Appropriate use of these strategies will also reduce the risk of a significant spill or upset, and may prevent the loss of valuable materials, production setbacks or impairment of an employee’s health.
Key steps in the pharmaceutical processes require particular attention and include operations where powders are handled. Liquid handling steps are also a concern and must be controlled where the potential for creation of liquid aerosol droplets exists.
For many unit operations, good work practices by employees are critical in controlling chemical exposure. Individual workers, whether they are in the lab, production, QA/QC, packaging, shipping and receiving, and regardless of their age or experience can positively or negatively impact their exposures. The proper use of engineering controls, correct work practices and procedures, and of PPE can enable the employee to limit their exposure to hazardous materials.
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