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Preparation of monoclonal antibodies on the pharmacy benchtop – risk assessment and practical considerations

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European Statement

Production and Compounding

Author(s)

Aidan Morris, Louise Byrne

Why was it done?

• mAbs were considered hazardous if handled by staff – prepared in a dedicated isolator in the PAU in TUH.
• No widely accepted standards for safe handling of mAbs, although more recent guidance allows preparation of some mAbs outside of PAUs once risks appropriately assessed.
• Significant reduction in production capacity in the PAU in early 2022 for planned repair work. Benchtop preparation of mAbs implemented to maintain patients’ treatment regimens and to reduce costs associated with outsourcing.

What was done?

• Preparation of monoclonal antibodies (mAbs) on the pharmacy benchtop temporarily introduced in the Pharmacy Aseptic Unit (PAU) of Tallaght University Hospital (TUH).
• Guidance from Ireland’s National Cancer Control Programme (NCCP) on Pharmacy Benchtop Preparation of mAbs reviewed and implemented.
• Risk assessment carried out for individual mAbs. List of mAbs suitable for benchtop preparation prepared.

How was it done?

• Implementation of the NCCP guidance on Pharmacy Benchtop Preparation of mAbs. Advice on risk assessments and safety, equipment and facilities, and staffing and training when preparing mAbs on the benchtop.
• Literature review of the hazards associated with handling mAbs – toxicity, immunogenicity, risk reduction measures. Individual mAbs assessed for suitability for benchtop preparation using Health Service Executive (HSE) risk assessment tool. This considered toxicity, immunogenicity and closed system transfer device (CSTD)-compatibility of mAbs, and personal protective equipment required.
• CSTD vial adaptor based on air cleaning (filter) technology replaced with vial adaptor with physical barrier (balloon) – additional safety measure. Dedicated area assigned for benchtop preparation – well-ventilated, clutter-free and easy-to-clean.
• Additional training on new vial adaptor provided to pharmacy technicians already experienced in aseptic compounding.

What has been achieved?

• List of mAbs suitable for benchtop preparation prepared. Conjugated antibody-drug complexes, mAbs of fully murine origin and mAbs not CSTD-compatible deemed unsuitable.
• mAbs prepared on the benchtop during period of reduced capacity, maintaining patients’ treatment regimens and reducing outsourcing costs, wastage.
• Facilitated by risk assessment and risk reduction using PPE, training and CSTDs.

What next?

• Although safety and handling requirements of mAbs not fully known, prudent to handle them with more care than most drugs but less than for cytotoxics.
• Contingency plan for benchtop preparation of mAbs in case of future reduced PAU capacity.
• Can be applied to other organisations experiencing periods of reduced capacity.

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