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Search Results for "certificate of analysis"

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Optimizing E. Coli cell growth performance with in-line, real-time OD600 (abs/mm) monitoring during the fermentation process
This study proposes utilizing an inline- variable pathlength spectrophotometer in a recirculation loop during fermentation to monitor and optimize the growth of E. Coli cells in real-time. This provides distinct advantages vs traditional methods due to the constant modification of path lengths to create a slope-based solution that is always within the linear range of the equipment with no buffer correction required. The growth curve is tracked in real-time using the slope (Absorbance/mm) at 600nm to measure cell density and to optimize growth performance of E. Coli cells. This will serve as a proof-of-concept for the optimal cultivation of E. Coli and production of pDNA. Speakers: Tanja Buch, Ramsey Shanbaky
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Go with the Flow: Protein concentration determination and automation during DP dilution processes using FlowVPE System
This presentation will give an overview of the journey from initial laboratory feasibility tests of the FlowVPE technology to implementation into an aseptic GMP facility for in-process control testing of biologics. In addition, the talk will highlight how the online technology sheds new light on the manufacturing process and increases product understanding. Building on the availability of real-time continuous protein concentration data, next steps in the development and implementation of a future automated human-free process execution will be shared. Speakers: Raf De Dier - Janssen
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ISO 14001:2015 Certificate - Sweden
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Go with the Flow: CTech FlowVPE System in combination with MALS for Real Time Molecular Weight (RT-MW) Applications
Multi Angle Light Scattering (MALS) can provide the real time molecular weight (Mw) of a pure solute or the average Mw of a solute matrix if the total concentration of the species is also available in real time. Analytical experiments with low protein concentration can use conventional fixed path length UV sensors, however these become saturated at the higher concentrations of manufacturing processes. The FlowVPE System enables the real time measurement of protein content in a wide concentration range, which can be coupled to MALS for RT-MW measurements. Besides a more agile process development, RT-MW can enable adaptive processing decisions and inform on product deviations Speaker: Andres Martinez-Roche
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Go with the Flow II: Implementing PAT strategy using the FlowVPX System for in-line monitoring during batch/continuous chromatography
As Seagen steps into next-gen processing, continuous processing has been one of our major area of focus for 2022. With the increasing production demands, process intensification requirements are increasing as well. To meet this, in-line process analytical technology (PAT) can enable comfortable processing. A stepping stone to this was our evaluation of VPX for further concentrating harvests and improving the chromatography efficiencies. Speaker: SeaGen-Aishwarya Ramanan
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Dialysis Tubing Weighted Closures – Repligen
Autoclavable, Spectra/Por Weighted Closures encase an acid- washed, fluorocarbon coated, stainless steel bar. When applied to bottom end of the dialysis tubing, the Weighted Closure acts like an anchor to maintain a vertical orientation of the sample.
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Magnetic Weighted Tubing Closure – Repligen
Autoclavable Spectra/Por Magnetic-Weighted Closures contain a magnetic fluorocarbon coated stainless steel bar, eliminating the need for conventional stir bars. Applied to the bottom end of the dialysis tubing, this closure provides complete submersion and gentle rotation of the sample on a stir plate.
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Scalable In-line Concentration Measurement for Biologic Process Development and GMP Manufacturing
In this webinar we will demonstrate how the FlowVPE Slope Spectroscopy System, when directly integrated in one or more locations of a process stream, has helped reveal process characteristics that until now have been hidden due to the limitations of the most commonly used online fixed pathlength UV-Vis solutions.
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Fast Facts: Accelerating downstream analytical testing for gene therapy
Watch the video or read the poster to learn:The benefits of rapid, reliable in-process testing for AAV downstream process development; How utilizing Slope Spectroscopy can remove or automate multiple process steps; Gene therapy case studies demonstrating use of the SoloVPE System to make real-time decisions for viral vector applications. Speaker: Harald Ehlen
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Accelerate Biologic Process Development and GMP Manufacturing Using In-Line Concentration Measurement
In this webcast, we will demonstrate how the CTech™ FlowVPX™ Slope Spectroscopy System, when directly integrated in one or more locations of a process stream, has helped reveal process characteristics that until now have been hidden due to the limitations of the most used online fixed pathlength UV-visual solutions. Speaker: Ramsey Shanbaky