Safe Handling Of Monoclonal Antibodies: Best Practices

By Claus Exenberger, Product Line Management

Handling monoclonal antibodies (mAbs) in production is a sensitive process that requires strict safety measures to prevent contamination, product loss and exposure to cytotoxic agents or radioisotopes, which can cause severe health issues. One effective safety measure is the use of closed-system-drug-transfer-devices (CSTDs) to prevent drug substances from being exposed to the environment. Regulations for mAb handling align with World Health Organization guidelines, including documenting production steps and sterilizing materials and equipment. Single Use Support has developed several products to aid in mAb production, such as the RoSS® Shell for secondary packaging, the RoSS.FILL for automated aseptic filling, and the RoSS.pFTU for freeze/thaw processing. These technologies help reduce errors and product loss in bioprocessing fluid management, and maintain the cold chain during transportation, addressing mAbs' sensitivity to temperature changes.