Biosimilar App Notes & Case Studies
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Media And Buffer Mixing Using The Xcellerex™ Magnetic Mixer
6/19/2024
A common requirement for media and buffer preparation in biopharma processing is powder-liquid mixing. Review the performance of a 3000 L single-use mixing system for preparing aqueous solutions.
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Scalability And Performance Of Single-Use Bioreactors
8/1/2023
Here, we provide scalability data as a guide for process development and cross-scale performance expectations and characterize performance attributes of the impeller, spargers, Ultimus® film, and sensors.
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Accelerating The Development And Optimization Of Cell Culture Media
10/18/2024
Here, we outline the use of a microbioreactor for the rapid screening and optimization of media formulations for perfusion processes, and its role in predicting the performance of larger-scale bioreactors.
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Demonstrated Strength And Durability Of Ultimus® Film
5/12/2023
Here, we outline the development of Ultimus® film and summarize the strength and robustness tests conducted in accordance with the American Society for Testing and Materials (ASTM).
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How To Successfully Isolate Your T Cells
10/7/2024
Explore the results of a study focusing on the early stages of the CAR T cell workflow, specifically the initial washing of leukapheresis followed by the isolation of T cells.
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Performing A Tangential Flow Filtration (TFF) Optimization Study
2/14/2023
This application note describes the recommended methods and techniques for optimizing a tangential flow filtration (TFF) process using a Cogent® Lab system and the Bio4C® Control Software.
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How To Ensure Correct Component Selection When Outsourcing To A CMO
3/22/2023
A CMO-recommended lyophilization stopper was contributing to several operational inefficiencies, including sticking and interlocking of stoppers during filling operations. Requalification work was required to make a change.
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Implementation Of Raman Spectroscopy For In-Line Monitoring
11/3/2022
Explore the development and implementation of Raman spectroscopy-based soft sensors for process monitoring of CPPs in bench scale, CHO cell, intensified seed trains (N-1).
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Getting CMC Right For Emerging Technologies
12/20/2023
Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
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Automated Cell Washing And Formulation In CAR T Cell Therapy Manufacturing
6/14/2024
Explore data collected from a study utilizing healthy donors in a typical CAR T cell processing workflow without a transduction step from a cross-site validation study.