Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility

When different drug products are produced in shared facilities, the potential for cross-contamination is always a concern that needs to be addressed. Drug products provide a benefit to the intended patient; however, as a cross-contaminant they can pose a risk. This is especially true when manufacturing oncology drugs, as many of them are highly potent substances with cytotoxic or genotoxic effects, while others are not.

In the early days of modern cancer therapy, chemotherapy with cytotoxic small molecules was the only treatment option. The development of targeted therapies based either on small molecules or monoclonal antibodies opened ground for rapid evolution and a large diversification in the clinical landscape. Especially in the field of immune-oncology, monoclonal antibodies accompanied by antibody-drug conjugates (ADCs) flourished in the pipelines of an increasing number of pharmaceutical and biotech companies.

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical. Outsourcing of drug product manufacturing to a contract manufacturing organization with experience in handling different products in shared facilities can be an option. However, the experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.