Single Use

The Proof Is in the Data: Extractables and Leachables

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Extractables and leachables (E&Ls) must be addressed in material and process validation programs. Extractables are compounds that can be extracted from a material in the presence of solvents with varying polarity under extreme conditions. Materials manufacturers should make extractables guides available to end users. Leachables are compounds that migrate from a material in the presence of an actual formulation under normal process operating conditions. Extractables information can be helpful as a basis for evaluation of potential process-equipment–related leachables (PERLs)testing. However,…

December 19, 2019

The Value of Plug-and-Play Automation in Single-Use Technology

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Automation can improve efficiency, track performance, adjust operations, and liberate operators from mundane routines. Automation requires a flexible set of tools that align well with the inherent flexibility of single-use technology (SUT). Although SUT flexibility enhances a biomanufacturer’s ability to modify operations to meet the needs of today’s dynamic industry, it also increases timelines and costs related to customizing and validating automated additions. We present herein the findings of a team of industry automation experts who are sharing their experiences…

December 17, 2019

Bioprocess Intensification – Fast, Flexible, and Efficient Solutions

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Propelled by single-use systems (SUSs), biopharmaceutical companies are approaching the ideal of continuous bioprocessing. In addition to improving process integrity and decreasing production costs, SUSs have enabled exciting ways to configure, operate, and evaluate manufacturing steps. Sensitive process analytical technologies (PATs) and discriminating data analysis platforms are supplementing those developments, helping process engineers and operators to study and modify workflows in unprecedented ways. The goal now is to intensify: to apply increasingly nuanced process knowledge and growing technological capability in…

November 21, 2019

Single-Use Technologies: Accelerating Bioprocess Design with Key Insights from the Experts

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Companies turn more and more to single-use technologies (SUTs) to mitigate production challenges — and with good reason. SUTs clearly decrease conventional costs while increasing process integrity. Yet as the writers in this compilation suggest, SUTs are now making possible new, exciting ways to configure, operate, and evaluate biomanufacturing. In this compilation, BioProcess International gathers key insights from biopharmaceutical industry experts at Sartorius Stedim Biotech to explore how SUTs can realize high-quality yet cost-effective end-to-end bioprocessing. The studies herein identify…

October 29, 2019

eBook: Automation — The Value of Plug-and-Play Automation in Single-Use Technology

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The biopharmaceutical industry’s movement away from large-scale, fixed-tank facilities to flexible facilities featuring single-use technologies (SUTs) has demonstrated the value of modular equipment and agile process design. SUTs have proven to be clear advantages to end users because those technologies enable quick facility build and changeover times. But linking SUT equipment with equally flexible automative technology has been difficult. Herein a group of automation experts from the BioPhorum Operations Group (BPOG) elaborate “plug-and-play” principles and introduce a supervisory control system…

October 28, 2019

The First Quantitative Industry Assessment of Single-Use System (SUS) Reliability: Raising the Bar for BPSA’s Value to Industry

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Over the past 24 months, the leadership of the Bio-Process Systems Alliance (BPSA) has initiated a pilot program to demonstrate the joint feasibility of collecting and sharing pertinent industry business data. We began with “quality-complaint data†centered on the premise that product complaints are tightly associated with product-quality defects in single-use systems (SUSs). This approach can be viewed as “risk assessment 101.†BPSA’s Representation of the Single-Use Industry BPSA is an industry organization primarily comprising drug manufacturers, single-use system suppliers,…

October 28, 2019

Single-Use Tubing Systems: Confidence Through Validation

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Single-use systems (SUSs) are becoming increasingly common in bioprocessing operations because of their low capital requirements and validation costs. As this trend continues to develop, pharmaceutical manufacturers are asking SUS manufacturers to provide assurance that their products comply with current good manufacturing practices (CGMPs) and do not alter drug products by exceeding established operating ranges. Certification of product cleanliness has become common for manufacturers of final packaging components such as vials and stoppers, but rarely are tubing products certified to…

October 23, 2019

Embedded Particles in Single-Use Bags: Risk to Bag Integrity and Drug Product Purity, or Only a Cosmetic Defect?

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When using single-use systems (SUS) to process biopharmaceuticals, preventing drug product contamination from extractables and leachables (E&Ls) and embedded particulate matter (gel particles) in the polymer films used to make bioprocess bags is critical. Using a pressure burst test to assess film integrity, Sartorius Stedim Biotech’s Klaus Wormuth and colleagues compared Flexboy and Flexsafe samples with gel-particle-free materials to assess their potential for contamination. The results showed that only large (2–4 mm2) gel particles affected the burst test results, concluding…

September 21, 2019

Large-Scale Capacity Strategies: Single Use, Multiuse, or Both?

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Early manufacturing facilities for large-scale production of biopharmaceuticals were, by necessity, very large. Low expression titers and blockbuster-market products such as monoclonal antibodies (MAbs) combined to require massive bioreactors — with capacities of 10,000– 20,000 L or more — and supporting infrastructure. In my early days covering the industry, I visited a few such facilities and was always awed by the huge tanks and what seemed like miles of piping. A 2010 Pharmaceutical Engineering article described a process modeling approach…

June 20, 2019

Biomanufacturing Scenarios: From the Biomanufacturing Technology Roadmap

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Drug Substance Scenarios Given the complexity of the biopharmaceutical industry and the increasing diversity of products and companies, it is clear that there will be no “one size fits all†solution to biomanufacturing. Instead, we see a range of biomanufacturing scenarios playing out over the next 10 years. Five high-level scenarios were selected for drug substance manufacturing and two for drug product to cover the full spectrum of process and facility types. Each facility type is associated with a representative…

June 20, 2019