Guidance on handling of monoclonal antibody (MAB) products

This document is issued under the cover of the NHS Pharmaceutical Quality Assurance Committee and has been produced by the committee in agreement with the Pharmaceutical Aseptic Services Committee (formerly the National Centralised Intravenous Additive Service Group) and the British Oncology Pharmacists Association.

Gene therapy or monoclonal antibody

Gene therapy, or more correctly gene transfer therapy, involves the deliberate introduction of genetic material into somatic cells for therapeutic, prophylactic or diagnostic purposes.

Monoclonal antibodies do not act in such a manner that they cause any transfer of genetic material and their effect is at a functional rather than genetic level. Monoclonal antibodies are not infective. Therefore a fundamentally different approach is required towards the handling of the two classes of substance.

Handling of gene therapy products will be covered in a new chapter to be included in the fourth edition of the “Quality assurance of aseptic preparation services” book.

Monoclonal antibodies

These agents affect a wide range of biological functions in a potentially profound manner. Those handling them should be aware of the nature of each product used and specific associated problems.

These recommendations are based on considerations of operator protection from contamination and patient protection from cross contamination. Ideally, the manipulation of monoclonal antibody preparations should be undertaken in pharmacy aseptic facilities, in accordance with the recommendation of the Breckenridge Report.^1,2 It is however acknowledged that this will not always be possible in the case of monoclonals, as a number of these products may be administered in the community.

There is a theoretical risk of operator sensitisation to these products as they are proteinaceous in nature. However, there is currently little evidence to suggest that this is a problem in practice at this time.

Production methods of some products may leave traces of non-human protein elements — typically murine — which may also potentially cause operator sensitivity on repeated exposure.

Policy Statement

Monoclonal antibodies may be manipulated in existing aseptic facilities, provided that adequate segregation from other products is achieved by the normal levels of process control expected within pharmacy aseptic units and the application of standard validated cleaning procedures.

This document supersedes other recently published guidance.

Ideally these products should be handled on a campaign basis, but it is accepted that due to workload pressures this will not always be realistic.

Consideration must also be given to specific hazards associated with individual products. Thus it will always be necessary to consider the mode of action of individual agents before introducing them into pharmacy aseptic units.

References

1. The Breckenridge Report (HC 76/9). London: Department of Health; 1976.
2. Audit Commission. A spoonful of sugar — medicines management in NHS hospitals. London: Audit Commission; 2002.