Applicability of vaporized peroxide for contamination control of lyophilized biohazards

Pharmaceutical Engineering

Authors: Birte R. Scharf, Maximilian Ferdinand Eizinger, Maren Saade, Andrea Hawe, Tim Menzen and Hussein Bachir

The majority of biologics and advanced therapy medicinal products (ATMPs) are parenterals that must be filled aseptically to maintain structural integrity and therapeutic efficacy, because terminal sterilization is not possible due to the instability of the product. Therefore, filling is often performed in isolators to ensure drug product quality and safety. Due to their sensitivity, biologics are often freeze-dried to increase product stability and shelf life.

This study explores the efficacy of vH2O2 decontamination for lyophilized biologics and ATMPs, considering the expected challenges for lyophilized drug products. We conducted experiments to investigate the influence of lyophilization and formulation composition, by using pharmaceutically relevant matrices, on the efficacy of vH2O2 decontamination. Our study highlights the difficulties in decontaminating lyophilized drug products in different pharmaceutically relevant matrices and proposes an isolator design solution to mitigate these challenges.

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Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards | Pharmaceutical Engineering