ARTICLES

Technical articles focused on the design, development, and commercialization of single-use regulated devices. 

Recent Articles

White Paper: Bridging the Gap from Batch to Continuous Bioprocessing

Abstract

For years, traditional batch manufacturing has dominated the biopharma industry. Recently, however, continuous bioprocessing has gained traction among biopharma manufacturers. Below is a look at some of the key differences between these two types of bioprocessing and the resources required for each. Finally, this paper will examine the ways that industry regulations have adapted to the advent of continuous bioprocessing and the ways that continuous production has impacted the single-use market.

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6 Filtration Challenges in Downstream Biopharmaceutical Production

In Brief

Membranes and membrane processes are efficient filtration tools in the manufacturing of biopharmaceutical products. These tools continue to evolve in response to new therapies and processing methods. The membranes used in separation and purification are beginning to play an even more important role as market demand for monoclonal antibodies (mAbs) and other gene and cell culture therapies have expanded in recent years. The global mAb therapeutics market is projected to grow from almost US$ 95.6 billion in 2017 to US$ 174.2 billion by 2026.

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Interview: Following up with Professor Charles Cooney on Bioprocessing

In Brief

We had the opportunity to sit down with Charles L. Cooney (Robert T. Haslam Professor of Chemical Engineering, MIT) to discuss what he sees as being on the horizon for biopharmaceuticals and single-use; how the field has advanced since the publication of his white paper on continuous bioprocessing; and some of the advantages and challenges in single-use technology. An excerpt from our interview is published below:

 

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Challenges and Risks in Batch Bioprocessing

In Brief

Batch bioprocessing is the industry standard in biopharmaceutical production. Although the advancements in biomedical technology that have allowed for batch bioprocessing have been invaluable, some aspects of batch bioprocessing come with limits and challenges. 

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Mutual Dependence: Continuous Bioprocessing and Single-Use Systems

In Brief

The rise of continuous biomanufacturing (CBP) is tied to the ascendance of single-use systems (SUS). Single-use disposables enable CBP by providing a high degree of adaptability, reliability, and continuous yield that effective CBP operations require. In response to market trends that prioritize personalized medicines, many companies are gradually substituting their fixed, stainless-steel implementations for adaptable, flexible, and disposable systems.  Single-use disposables presently on the market include disposable sensors, connectors, bioreactors, and more.

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