Aseptic Processes Safeguard Biologics

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To protect patient safety, drug developers and manufacturers must consider every possible route of contamination of the drug substance (DS) or drug product (DP) through all stages of production. Aseptic processes must be employed from the filling lines, containers, and stoppers to the air in the surrounding manufacturing space to maintain a sterile environment throughout fill/finish. This article explores the aseptic processing strategies biologics developers can integrate to safeguard DS and DP and examines the monitoring tactics helpful in maintaining a sterile environment.

Read this article in Pharmaceutical Technology’s May 2023 Trends in Manufacturing eBook.

About the author

Jeong Jin-hyeok is principal scientist in drug product at Samsung Biologics.

Article details

Pharmaceutical Technology
eBook: Trends in Manufacturing
May 2023
Pages: 8–12

Citation

When referring to this article, please cite it as Jin-hyeok, J. Aseptic Processes Safeguard Biologics. Pharmaceutical Technology’s Trends in Manufacturing eBook. May 2023.