Author Archives: Paul Priebe

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 Technology in Upstream Processing: A Roundtable Discussion

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The Sartorius upstream portfolio addresses key strategic challenges facing the biopharmaceutical industry: Increased speed to clinic/market and lowered capital costs, with improved process control. Fully scalable, proven process solutions for cell line, media, and process development through commercial manufacturing accelerate upstream development and simplify manufacturing. Novel high-throughput development tools for intensified processes incorporate the latest in process analytics, multivariate data analysis (MVDA), and design of experiments (DoE) software tools. These tools are designed to compress development timelines and to scale…

June 4, 2019

Development of a Standardized Extractables Approach for Single-Use Components: General Considerations and Practical Aspects — A Manufacturer’s Perspective

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The subject of extractables for single-use bioprocess contact materials has been a subject of heated debate since roughly the summer of 2012, when the first ISPE paper was published issuing a call to action to develop a standardized extractables protocol for the industry (1). As a supplier that pioneered the science of extractables (2‒11) and has published extractables data for our products for over 20 years, Sartorius Stedim Biotech (SSB) took the opportunity to look back, take stock, rationalize, and…

October 23, 2018

Outsourcing to Enhance Assurance of Supply: Application of Counterintuitive Supply Chain Strategies — A Case Study

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Single-use technologies have transformed biopharmaceutical manufacturing by providing tremendous and proven opportunities to reduce costs, improve flexibility, and shorten cycle times. The expansion of such technologies into commercial production has naturally raised new challenges for both end users and suppliers, thus driving the need for a critical look at risks associated with their use. End users now face a new challenge: how to assess their own supply chains for robust assurance of supply. What is the suppliers’ responsibility in addressing…

May 17, 2016

Single-Use Technologies: BIO Theater @ Interphex 2015

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Andrew Lidums (NA business development manager, Parker domnick hunter) 2:30–2:55 pm Implementing a Risk-Management–Based Approach to the Prevention of Mycoplasma Contaminations Lidums began with a recent report from Genentech, where a 150-µm long Leptospira organism from a drainage ditch outside the facility managed to penetrate 0.1-µm filters. The company solved this problem by lowering the temperature of the filtration operation, which made the bacteria more rigid and kept them from getting through. Clearly, however, contaminations happen even at large facilities.…

August 24, 2015