Single-use systems (SUS) for biopharmaceutical manufacturing have components and assemblies made primarily from polymeric materials, such as silicone or thermoplastics (e.g., polyethylene).  

interviewedCsilla Kollar, technical services and development scientist, and Jennifer Gemo-Mathis, Global Bio-Pharma marketing leader, both at The Dow Chemical Company, which manufactures silicone tubing and assemblies for biopharmaceutical manufacturing, about what to consider when specifying and using single-use systems.

BioPharm International's Single-Use Systems 2018

	When referring to this article, please cite it as J. Markarian, “Considering Silicone Tubing and Assemblies,” 

BioPharm International Single-Use Systems 

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Silicone is one of the polymeric materials that can be used for single-use components and assemblies in biopharmaceutical manufacturing. 

Considering Silicone Tubing and Assemblies

The polymeric nature of single-use systems creates the potential for extractables and leachables to impact the production of drug products. The qualification of single-use systems is, therefore, different and more challenging than stainless-steel systems.

spoke with Andrew Bulpin, head of process solutions for MilliporeSigma; Danny Hower, extractables & leachables supervisor, SGS; Dr. Dujuan Lu, extractables & leachables technical client manager, SGS; Helene Pora, vice-president, technical communication and regulatory strategy, Pall Biotech; Eric Isberg, director of Life Sciences at Entegris; and experts from the Bio-Process Systems Alliance (BPSA) Technical Committee, about the challenges and procedures involved in the qualification of single-use systems.

BioPharm International's Single-Use Systems 

	When referring to this article, please cite it as S. Haigney, "Qualification of Single-Use Systems," 

BioPharm International Single-Use Systems

An understanding of the unique nature of single-use systems, and how they interact with each biomanufacturing process, is important when qualifying single-use systems.

Qualification of Single-Use Systems

spoke with Andrew Bulpin, head of process solutions for MilliporeSigma; Danny Hower, extractables & leachables supervisor, SGS; Dr. Dujuan Lu, extractables & leachables technical client manager, SGS; Helene Pora, vice-president, technical communication and regulatory strategy, Pall Biotech; Eric Isberg, director of Life Sciences at Entegris; and experts from the Bio-Process Systems Alliance (BPSA) Technical Committee, about managing quality and extractables and leachables (E&L) in single-use systems.

	When referring to this article, please cite it as S. Haigney, "Managing Quality in Single-Use Systems," 

Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment.

Managing Quality in Single-Use Systems

The experience gained and knowledge compiled from legacy biomanufacturing operations establish a reference. This reference can benefit a thorough assessment of new methods and technologies, and it can aid in the transition or adoption of new approaches. With respect to stainless-steel and single-use bioreactors, lifecycle, design space, and product platform concepts are discussed in this article. 

BioPharm International's Single-Use Systems

	When referring to this article, please cite it as K. Clapp, "Comparing the Supply Lifecycle of Bioreactors," 

Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.

Comparing the Supply Lifecycle of Bioreactors

	Single-use bags are widely used in biopharmaceutical manufacturing. A crucial aspect for drug manufacturers is the reliability of the supply chain of single-use bags. 

spoke to Sara Bell, senior marketing manager, Single-Use Solutions, MilliporeSigma, about the supply-chain challenges from a single-use supplier’s perspective.

	When referring to this article, please cite it as A. Siew, "An Integrated Approach to Shipping Liquid in Single-Use Systems," 

Robust materials management, supplier quality management, quality control, and business continuity planning are essential to ensure continuous supply of single-use bags.

Assurance of Supply

Both biosimilars and biobetters are biological products that are developed based on a reference product already on the market (a biologic new molecular entity [NME]). They differ from each other, however, particularly in the regulatory pathway each would take to commercialization (1,2). A biosimilar is considered highly similar to the reference product and is expected to have no clinically meaningful differences in terms of safety, purity, and potency; whereas, a biobetter is a product that is in some way an improvement over an existing biological product, such as by the use of an improved delivery system, improved formulation, or other modification that enhances efficacy and safety.

BioPharm International Single-Use Systems

	When referring to this article, please cite it as F. Mirasol, “Biosimilars and Biobetters Strategies and Challenges,” 

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

Biosimilars and Biobetters Strategies and Challenges

Biotechnology industries have adopted single-use systems in their manufacturing processes. The adoption started with applications for managing peripheral fluids and is now moving towards the main drug manufacturing process. This transition is leading to more challenging safety and quality requirements especially in very demanding or high stress applications such as transportation of bulk drug substances (BDS). There is a need to define safe, stable and integral systems for shipping biopharmaceutical solutions around the world. This article provides qualification data under the very severe conditions contained within international ASTM D4169 norms.

	When referring to this article, please cite it as E. Vachette, F. Bazin, M. Barbaroux, and J. Cappia, "An Integrated Approach to Shipping Liquid in Single-Use Systems," 

Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.

An Integrated Approach to Shipping Liquid in Single-Use Systems

The increasing number of biologic drugs in development is driving the need for more efficient and cost-effective manufacturing technologies, including in single-use technologies for final fill/finish. Single-use technologies have become increasingly prevalent in fill/finish as a result of industry demand.

spoke to BJ Hull, vice-president and general manager (Camden), Emergent BioSolutions; Sara Bell, senior marketing manager, Single-use Solutions, MilliporeSigma, a business of Merck KGaA, Darmstadt, Germany; and Claus Feussner, PhD, senior vice-president Vetter Development Service, Vetter Pharma-Fertigung, on the adoption, benefits, and challenges of single-use systems in final fill/finish manufacturing.

	When referring to this article, please cite it as F. Mirasol, “Single-Use Boosts Fill/Finish in Commercial Biomanufacturing,” 

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

BioPharm International-06-15-2018