NHS Pharmaceutical Quality Assurance Committee – guidance on the Safe Handling of Monoclonal Antibody (mAb) Products

The NHS Pharmaceutical Quality Assurance Committee comprises the lead specialist Quality Assurance Pharmacists who work for the National Health Service (NHS) in the United Kingdom.

Occupational health and safety (OHS) exposure risks associated with traditional cytotoxic drugs are well established.

However, there is little information regarding the OHS exposure risks of monoclonal antibodies (mAbs). Hence these are often based on theoretical risks associated with the modes of action of the mAb, the risk of production of antibodies against the agent if future therapeutic treatment is needed or reactions due to the proteinaceous nature of the mAb.

The NHS Pharmaceutical Quality Assurance Committee guideline provides a mechanism and guidance for individual organizations to assess these factors in their own facilities and suggests a range of suitable risk minimization and control measures that may need to be considered.

In this guideline, closed system reconstitution devices (CSRDs/CSTDs) are not seen as essential for use in the preparation of mAb doses. However, they are seen as providing an additional level of safety both in terms of operator protection and potentially reducing the risk of microbial contamination of prepared doses. Tevadaptor® can add this level of protection.