Scaling Manufacturing Processes Using  Single-Use Technologies

Lipinski,Kai;

Scaling Manufacturing Processes Using Single-Use Technologies

Published on: February 15, 2023

Pharmaceutical Technology, Pharmaceutical Technology, Bio/Pharma Outsourcing Innovation, February 2023, Volume 2023 eBook, Issue 1

Pages: 16-21

Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.

Since biological drugs first became available, their demand has been increasing—with the biologic market being valued at approximately US$302.63 billion in 2020 and expecting to reach US$509.23 billion by 2026 at a compound annual growth rate of 9.06% (1). With advancements in research and technologies, the diversity of biological drugs available is broad, including monoclonal antibodies (mAbs), prophylactic vaccines, gene therapy viral vectors (mainly lentivirus and adeno-associated virus), cell therapies (e.g., chimeric antigen receptor T-cell therapy and modified stem cells), and oncolytic viruses (e.g., adenoviruses, herpes viruses, and vaccinia virus).

As a result, the bioreactor vendor and contract development and manufacturing organization industries are under pressure to increase production scale. To meet demand, these industries must feasibly scale up while considering safety, manual operator handling, engineering, infrastructure, costs, and finally biological processing itself.

Read this article in Pharmaceutical Technology's February 2023 Bio/Pharma Outsourcing Innovation eBook.

About the author

Kai Lipinski, PhD, is the chief scientific officer of Vibalogics.

Article details

Pharmaceutical Technology
eBook: Bio/Pharma Outsourcing Innovation
February 2023
Pages: 16-21

Citation

When referring to this article, please cite it as Lipinski, K. Scaling Manufacturing Processes Using Single-Use Technologies. Pharmaceutical Technology's Bio/Pharma Outsourcing Innovation eBook (February 2023).