Search results for " pilot"
Article
Flow Accuracy and Gradient Performance of ÄKTA pilot 600 Chromatography System
Explore the next generation ÄKTA, ÄKTA pilot 600
Article
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
In the joint pilot program, which began in March 2011, FDA and EMA agreed to share knowledge, ensure consistent adherence to international guidelines related to QbD and promote the availability of pha…
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Explore ÄKTA pilot 600 in 3D
See how ÄKTA pilot™ 600 supports scale-up from process development to GMP clinical scale.
Explore this ÄKTA™ system in 3D
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
In this study, the predefined sanitization method developed for ÄKTA pilot 600 was assessed. In a microbial challenge test, parts were exposed to a bacterial strain recommended by the United Stat…
Article
Visualize your ÄKTA Pilot 600S in 3D
When when thinking of getting a new system, add components and study 3D models of systems like ÄKTA pilot 600S, ÄKTA avant, ÄKTA pure, ÄKTA go, and ÄKTA start in Cytiva’s Puri…
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Discover ÄKTA™ Pilot 600 with Martin
In this easy-to-use online learning series, our application specialist, Martin, gives detailed instructions on how to use the ÄKTA™ pilot 600 chromatography system.
Create your user…
Article
Multidimensional Scale-Up of a Monoclonal Antibody Capture Step, Using ÄKTA™ pilot 600
In this work, a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system, is demonstrated. Column volume per…
Article
Biopharma Seeks Balance
New challenges to manufacturing
Manufacturing processes have traditionally been established through lengthy development steps from laboratory scale, to pilot scale, to commercial scale; howe…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
After the demonstration run, this process was transferred to the pilot plant for manufacturing clinical supplies.
Early Platform Modifications
The original process was developed at Pfizer fo…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
In 2008, the FDA's Office of Biotechnology Products invited companies to participate in a pilot program involving the submission of quality information for biotechnology products in an Expanded Change…