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Article Setting Up Bioprocessing Systems for Digital Transformation
“Plants need strategies and technology to maintain ‘chain-of-identity and meta data’ for data as it moves across various systems,” Lenich says. He notes that new IIoT devices add a vast array of c…

Article Best Practices in Adopting Single-Use Systems
The adoption of single-use systems in biopharmaceutical production originated with the desire to minimize cleaning and associated validation. Before long, bioprocessors recognized the value of flexibi…

Article Cell-free Expression Systems Pose Cell Culture Alternative
One approach that potentially offers the benefit of a “cleaner” biologic product in upstream processing is the use of cell-free expression systems. By producing less waste upstream, there is the poten…

Article Industry Adoption of Single-Use Systems Remains Low
Companies with a longer history of using single-use systems are the ones who are more likely to embrace newer technologies as well as to invest in them, but companies who hesitate or are reluctant to …

Article Design and Qualification of Single-Use Systems
With increasing regulatory oversight of SUT processes, it’s worthwhile to review basic concepts of design and qualification that apply to single-use components and systems (SUS). Equipment Design …

Article Supply Chain Challenges for Single-Use Systems
By Jennifer Markarian  The implementation of single-use systems (SUS) for biopharmaceutical manufacturing as an alternative to or in combination with traditional stainless-steel equipment o…

Article The use of Xcellerex™ mixing system as slurry tank when packing chromatography columns
 The capability of the mixing system to keep the chromatography medium (resin) in suspension and the possibility to integrate the system in column packing were studied. The results show that XDM Quad …

Article Best Practices in Qualification of Single-Use Systems
Currently, single-use systems (SUS) also include disconnectors, disposable filling needles, and sensors. The technology is still evolving, and the industry can expect further advances in the future. …

Article Modern Manufacturing Systems Key to FDA Quality Initiative
To support real change, FDA’s Center for Drug Evaluation and Research (CDER) has launched a full-court press to convince industry of the value of adopting modern drug manufacturing systems. The agency…

Article Evaluating E&L Studies for Single-Use Systems
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni Biopharmaceutical companies have increased the adoption of single-use systems (SUS) and components (i.e., polyethylene bag…

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