White Paper

Challenges With Modern Oncology Drugs: Aseptic Preparation Of Cytotoxic Compounds

Source: Bioquell Inc.

Jane Metcalfe BSc (Hons), MSc, Field Applications Specialist, Bioquell UK Ltd

Chemotherapy treatments are advancing rapidly with increasing numbers of clinical trials in the field of oncology. With the emergence of personalised medicine and targeted therapeutics, there has been a rise in the number of biological therapies used to treat cancer. The amalgamation of targeted therapies and traditional cytotoxic drugs, has led to the formulation of antibody-drug conjugates which ensure direct cytotoxic delivery to tumour cells.

It is anticipated that hospital pharmacies will be compounding a diverse range of cytotoxic products including new drug conjugates in future. In order to accommodate these changes, it is paramount that rigorous systems of quality risk management (QRM) are employed. Good manufacturing practice (GMP) must be adhered to, in order to assure that products are produced accurately, safely and aseptically. Workloads in technical services departments are expected to increase, so capacity needs to be examined alongside service provision.

With the predicted increases in throughput, validated methods of isolator bio-decontamination are imperative to reduce the resident contamination in the critical zone. A marked reduction in bioburden combined with good aseptic technique, can facilitate product protection and ultimately, patient protection. Isolator technology can be utilised to ensure the segregation of products to prevent cross-contamination. Historically this has concerned the ß-lactam group of antibiotics but, with advances in pharmacology and drug design, this will encompass additional
product types. Both legislative and regulatory guidelines will require individual consideration and procedural application.

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