Jeong Jin-hyeok is a lead specialist in drug product at Samsung Biologics.

Jeong Jin-hyeok

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.

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

When referring to this article, please cite it as Jin-hyeok, J. Aseptic Processes Safeguard Biologics. 

Articles

Aseptic techniques must be practiced throughout all stages of biologics production.

Aseptic Processes Safeguard Biologics

The ability of the biopharma industry to meet the worldwide demand for messenger RNA vaccines was facilitated by contract development and manufacturing organizations. These partners promptly adapted their facilities and capabilities specifically for vaccine production, offering contract fill/finish and cold chain services required to meet demand. Examining the lessons learned from the COVID-19 pandemic, this article provides a perspective on the strategies and tactics taken to deliver a better drug development program and highlights the importance of remembering key lessons as the industry moves toward an era of new drug modalities.

Pharmaceutical Technology’s February 2023 Outsourcing Innovation eBook

Preparing for a New Wave of mRNA Technologies

Pharmaceutical Technology’s Outsourcing Innovation eBook


eBook: Outsourcing Innovation, February 2023
February 2023
Pages: 30–32

When referring to this article, please cite it as J. Jin-hyeok, “Preparing for a New Wave of mRNA Technologies," 

Pharmaceutical Technology Outsourcing Innovation

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.