Single Use

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

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…

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

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…

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

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,…

Single-Use Tubing Systems: Confidence Through Validation

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…

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

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…

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

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…

Biomanufacturing Scenarios: From the Biomanufacturing Technology Roadmap

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…

A Shift of Mindset: How Single-Use Systems Influence Bioprocess Engineering and Project Execution

In past decades, the focus in bioprocess engineering was on traditional stainless steel project management, which is highly dependent on established project schedules. Many milestones, tasks, and deliverables during basic and detailed design and execution were implemented in the same tried and tested way by engineering, suppliers, and biopharmaceutical companies. Making decisions was complicated by alignment with long lead items. With the introduction of single-use (SU) technologies, the transition in execution and optimization of project management only just has been…

The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production – Part 3: Best Practices for Supplier Selection, Qualification, and Validation to Ensure Supply Chain Security

Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. Corporate members include plastic equipment suppliers, service providers, and users in the biopharmaceutical industry who share this mission. A key focus of BPSA’s core activities is to educate its members and others through sharing of information and development of best practice guides that help suppliers, users, and…

The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production –
Part 2: Regulatory Overview

The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. Corporate members include plasticequipment suppliers, service providers, and users in the biopharmaceutical industry who share this mission. A key focus of BPSA’s core activities is to educate its members and others through sharing of information and development of best practice guides that help suppliers, users, and…