Stability challenges of oncological medicines: The overlooked role of industrial pharmacy

Abstract

Background

Ensuring the stability and quality of oncological medicines remains a major challenge across both industrial and hospital settings. These products are often biologics or highly sensitive compounds are vulnerable to chemical, physical, and microbiological degradation pathways that can compromise therapeutic efficacy and patient safety.

Objective

This review provides an overview of the main stability challenges associated with oncological medicines and highlights the complementary roles of industrial pharmacy and hospital pharmacy in preventing degradation, contamination, and handling-related risks.

Discussion

Chemical degradation mechanisms including oxidation, deamidation, acylation, and photo-induced reactions are particularly prominent in peptides, monoclonal antibodies, and antibody–drug conjugates. Physical instability, driven by temperature fluctuations or hydrophobic payloads in ADCs (, can promote aggregation and reduce shelf-life. Microbiological instability remains a critical concern, especially in immunocompromised patients, and underscores the importance of controlled environments, aseptic technique, and compliance with sterility and endotoxin standards. Contamination risks particulate, microbiological, or cross-contamination are markedly lower when oncological medicines are prepared in ISO-classified clean rooms, isolators, or closed-system transfer devices (CSTDs). Post-reconstitution stability is equally dependent on strict cold-chain management, appropriate conditioning, and optimized clinical workflows. Robotic compounding systems further enhance safety by improving precision, reducing environmental exposure, and strengthening traceability.

Conclusion

Stability preservation for oncological medicines requires an integrated approach that bridges industrial formulation strategies, advanced manufacturing technologies, and rigorously controlled hospital practices. Strengthening the collaboration between industry and clinical pharmacy is essential to ensure the quality, safety, and therapeutic performance of anticancer treatments.