Search results for " system"

Article Ready-to-use fluid management for inline conditioning (IC) large-scale chromatography systems
This application note describes solutions for handling buffers and samples in a process setup for BioProcess™ or ÄKTAprocessTM system for IC. The IC system can be operated with either conventiona…

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 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 of…

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 Vaccine process development using Cytodex™ microcarriers in WAVE™ Bioreactor systems
The MDCK cell growth in WAVE Bioreactor system was scalable to 2 l and 10 l working volumes. The cells reached a maximum concentration of 3 × 106 cells/ml. Vero cells were cultivated on Cytodex 1 and …

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 Highly efficient inoculum propagation in perfusion culture using WAVE Bioreactor™ systems
All cultures were grown in disposable Cellbag™ bioreactors using the WAVE Bioreactor system. Cell concentrations of 4.8 × 107 cells/mL were achieved in perfusion culture, whereas the final cell concen…

Next Page