As single-use systems (SUS) have increasingly been implemented in GMP biopharmaceutical production, supply-chain assurance for SUS materials, components, and assemblies has become even more important. Dual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy. However, these tenets of supply-chain management are often misapplied and undervalued, leading to potential risk that can result in delays or even stoppages in critical drug production.

	When referring to this article, please cite it as T. Korwan and J. Harp, " New Strategies for Managing Single-Use Components," 

BioPharm International Single-Use Systems 

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Dual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy, but must be applied correctly.

New Strategies for Managing Single-Use Components

Simple components such as tubing and gaskets are important for maintaining the physical integrity of a bioprocess setup. Single-use versions of these components offer convenience as well as play a role in maintaining aseptic processes, thus helping to ensure that the bioprocess setup is a closed system. In a discussion with Ray Baldwin, business development manager for Biopure, a Watson-Marlow Fluid Technology Group (WMFTG) company, 

explores single-use components and the role they play in bioprocessing.

	When referring to this article, please cite it as F. Mirasol, "The Importance of Single-Use Components for Bioprocessing," 

Simple components help maintain physical integrity throughout a bioprocess setup, and single-use components play a role in ensuring a closed system for aseptic processing.

The Importance of Single-Use Components for Bioprocessing

Because the manufacturing of biotherapeutics requires large volumes of process liquids, buffer preparation is an important aspect of large-scale biomanufacturing. To address the challenges of buffer preparation and ease bottlenecking, MilliporeSigma developed the BioContinuum Buffer Delivery Platform, a new component to its BioContinuum Platform. 

spoke with Andrew Bulpin, head of process solutions at MilliporeSigma, about what the company’s buffer delivery platform entails, such as single-use components, and the benefits it offers to biomanufacturers.

	When referring to this article, please cite it as F. Mirasol, "Buffers Benefit from Single-Use Systems," 

BioPharm International Single-Use Systems

Single-use systems offer a solution to the challenges inherent in buffer preparation, which can be the cause of bottlenecking in bioprocessing.

Buffers Benefit from Single-Use Systems

The global biopharmaceutical market is set to grow by a compound annual growth rate of nearly 14% over the next six years, according to market research. Reported drivers for this progression include an aging global population, an increase in the prevalence of chronic conditions, and an overall rise in the uptake of biopharmaceutical products on the global market.

	In this article, the benefits, evolution, and limitations of single-use systems in biomanufacturing are explored.


	eBook: Single-Use Systems 2019
	June 2019
	Pages: 4–8

	When referring to this article, please cite it as F. Thomas, "Thinking Flexibly in Biomanufacturing," 

Single-use systems may offer a suitably flexible solution to the biomanufacturing challenges of cost and time-to-market.

Thinking Flexibly in Biomanufacturing

Several companies have invested in 2000-L single-use bioreactors to expand production capabilities, including Thermo Fisher Scientific, GE Healthcare, Pall Biotech, and Sartorius Stedim Biotech. This article highlights the features, functions, and capacities of several large-volume bioreactors by these companies that are used in the market today.

	When referring to this article, please cite it as A. Lowry, "Single-Use Bioreactors Unwrap Commercial Manufacturing Options," 

BioPharm International Single-Use Systems

This article provides a review of various 2000-L single-use bioreactors used by biopharmaceutical suppliers for commercial production.

Single-Use Bioreactors Unwrap Commercial Manufacturing Options

Single-use systems (SUS) are increasingly becoming the norm in biologics development and manufacturing. Approximately 85% of the pre-commercial biopharmaceutical sector use SUS, and they are increasingly being adopted for commercial manufacturing. SUS have significant advantages but are not without drawbacks. A 2018 survey showed that 73.3% of biologics insiders listed contamination from extractables and leachables to be a major problem.

	When referring to this article, please cite it as A. Nixdorf, "Extractables and Leachables: Determining Risk in Single-Use Systems," 

As SUS become prevalent in the biologics industry, the question of safety becomes increasingly important.

BioPharm International-06-15-2019

New Strategies for Managing Single-Use Components

The Importance of Single-Use Components for Bioprocessing

Buffers Benefit from Single-Use Systems

Thinking Flexibly in Biomanufacturing

Single-Use Bioreactors Unwrap Commercial Manufacturing Options

Extractables and Leachables: Determining Risk in Single-Use Systems