Publications by authors named "Jessica Sebellin"
Prolonging the stability of cetuximab (Erbitux®) and panitumumab (Vectibix®): An orthogonal assessment of physicochemical, biological and microbiological properties of original opened glass vials and diluted saline preparations.
Debora Carpanese Valentina Rossi Veronica Di Paolo Luigi Quintieri Alessandro Penna Jessica Sebellin
Int J Pharm
January 2024
The two anti-epidermal growth factor receptor monoclonal antibodies (mAbs) cetuximab and panitumumab are the pillars for the treatment of EGFR-positive, KRAS wild-type metastatic colorectal cancers. However, stability data of these mAbs are generally missing or incomplete. Here, we report for the first time an orthogonal analysis of the stability of cetuximab (Erbitux®) and panitumumab (Vectibix®), either undiluted vial leftovers or saline dilutions in polyolefin/polyamide infusion bags.
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- Preparation of injectable anticancer drugs in hospitals is risky, necessitating thorough risk assessments and quality assurance to minimize dangers and ensure microbiological stability in the final product.
- A deductive method was used at the IOV-IRCCS hospital to evaluate the "added value" of drug preparations, categorize their risk levels, and establish corresponding quality assurance systems in line with Italian health guidelines.
- A microbiological risk assessment resulted in a maximum stability period of 7 days for drug preparations, enhancing safety and quality through an integration of risk-based stability predictions with existing literature.