In this presentation, learn how you can ensure ultra-low residual hydrogen peroxide levels in GMP pharmaceutical production to avoid oxidation of biologic drugs.

Ulla Grauschopf, Katherine Thomas, Joerg Luemkemann, Sebastian Schneider, Ada Hui, Y. John Wang and Kirk Eppler

Abstract: Biological drug products are usually filled into the primary packaging container under aseptic conditions. Modern fill–finish plants often employ containment installations like isolators to ensure the highest level of sterility assurance for the product. The industry standard for containment decontamination is the treatment with vapor phase hydrogen peroxide. Although being very efficient in sterilizing the containment, its oxidizing potential makes it a threat to the drug product filled after the decontamination cycle. The following chapter elaborates on the determination of scientifically meaningful product protection measures. It connects the concept of molecule-specific sensitivity assessment to the determination of VPHP residuals in the containment and to the uptake of VPHP from the atmosphere surrounding the drug product during the fill–finish process.

Material from: Warne, Nicholas W., Mahler, Hanns-Christian, Challenges in Protein Product Development, published 2018 American Association of Pharmaceutical Scientists. Reproduced with permission of SNCSC.

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