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Pharmaceutical Technology

Pharmaceutical Technology, Bio/Pharma Outsourcing Innovation, February 2023
Volume2023 eBook
Issue 1
Pages: 16-21

Scaling Manufacturing Processes Using Single-Use Technologies

Author(s):

Kai Lipinski

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.

RGtimeline - Stock.adobe.com

RGtimeline - Stock.adobe.com

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).

Articles in this issue
BillionPhotos.com/Stock.adobe.com – preparing for emerging mRNA technologies requires adapting fill/finish and cold chain capabilities.
Preparing for a New Wave of mRNA Technologies
CRO advances
CROs Gaining a Competitive Edge
Biopharmaceutical Manufacturing Growth
Biopharmaceutical Manufacturing Growth
Forecasting Trends in Pharma Innovation
Forecasting Trends in Pharma Innovation
information transfer
Communication is Key in Complex Tech Transfer
Scaling Manufacturing Processes Using Single-Use Technologies
Scaling Manufacturing Processes Using Single-Use Technologies

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