White Paper

Validation Of A Glovebox Workstation

By Jan Eudy, Cleanroom/Contamination Control Consultant, ISO 9000/cGMP auditor, HACCP/Food Safety Auditor

Flow Sciences_2

Clinical researchers are creating ADC’s (antibody drug conjugates) that consist of an antibody, a linker, and a cytotoxic drug. By combining the unique targeting of monoclonal antibodies with the cancer killing ability of cytotoxic drugs, the use of this type of ADC allows sensitive discrimination between healthy and diseased tissue. These anti-cancer drugs use high potency active pharmaceutical ingredients (HPAPI’s) to achieve targeted therapy for treatment of people with cancer. Many of the HPAPI’s are novel compounds of unknown potency and toxicity. Some cytotoxic agents are made of a combination of nanoparticles. The establishment of limits of operator and patient exposure for nanoparticles are only recently being investigated. However, nanoparticles less than 10nm (nanometers) may be absorbed through the skin. The greatest risk to the operator is the inhalation of the HPAPI’s. The occupational exposure limit (OEL) is based on the toxicity of the drug. The OEL is measured by the potency of the drug, the frequency of contact with the drug, the duration of contact with the drug, and the quantity of the drug. Unfortunately, much of this is unknown when researchers are working with nanoparticles and ADC’s. Therefore, during the risk assessment personnel protection must predict protection in a worst-case environment. The recommended containment solution specified is typically Occupational Exposure Band (OEB) 4 or 5. This is a system for grouping compounds of similar toxicity and potency to guide the assessment of the engineering controls required to achieve safe manufacturing of ADC’s in research, development, and manufacturing work environments.

Many existing research labs, pharmaceutical and biopharmaceutical manufacturers, and contract manufacturing organizations (CMO’s) are not designed nor are they equipped with the engineering controls to safely handle the manufacture of ADC’s. The safe manufacture of ADC’s requires more modern facilities, equipment, and engineering controls as well as programs, practices, and procedures to adequately protect the operators and the work environment.

The FDA mandates that any substance manufactured for human consumption must strictly comply with current good manufacturing practices (GMP). Flow Sciences, Inc. (FSI) provides verified containment and control solutions per current GMP requirements for manufacturing ADC’s for clinical trials with the glovebox workstation to maintain exposures below acceptable limits. Therefore, the Flow Sciences, Inc. Glovebox Workstations used for the manufacture of ADC’s are fully validated. A master device record (MDR) documents the entire validation process of the glovebox workstation from design, construction, quality control, and facility acceptance testing. The ISO 9001 based quality management system and lean manufacturing concepts allow the rapid construction of glovebox work stations.

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