Biosimilar App Notes & Case Studies
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Using Automated Spinoculation For CAR T Cell Lentiviral Transduction
2/26/2024
There is a growing demand for closed and automated lentiviral transduction steps in CAR T cell therapy workflows. Learn about a potential solution to address this unmet need.
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Characterization Of Host Cell Proteins By Liquid Chromatography - Mass Spectrometry
2/26/2024
Explore an established liquid chromatography – tandem mass spectrometry (LC-MS/MS) method for characterization of residual HCPs in monoclonal antibody (mAb) products.
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Bulk Filling Of Drug Substance | Accurate Aliquoting
4/24/2024
Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.
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COVID-19 Impact To Biological Drug Products Safety
6/13/2022
Review currently available literature and our recommended COVID-19 virus detection test methods and susceptibility of common biological host cells to infection.
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Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies
2/9/2024
In an example using rituximab and its biosimilars, explore the significance of minor differences of glycosylation in antibodies and its impact on their properties and functionality.
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Bioreactor Scalability Supports Intensified Upstream Process Development
7/31/2023
In this study, key parameters for the Mobius® 3 L Single-Use Bioreactor and the 50-2000 L Mobius® iFlex Bioreactor impeller designs were characterized. Learn about bioreactor scalability for intensified processes.
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Optimizing Recovery On The Sepax™ Cell Processing System
7/21/2022
Using a model T-cell line, we demonstrate the impact of varying rinse volume, intermediate volume, and manual extraction parameters on overall cell recovery with a final product dose volume of 20 mL.
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Biacore™ SPR Systems For Titer Analysis Of Adeno-Associated Virus
10/13/2022
We describe the performance of two assays for titer analysis of adeno-associated virus (AAV), serotype 2 and serotype 5, based on surface plasmon resonance (SPR).
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Alkaline Stability Of Modern Protein A Chromatography Resins
7/12/2023
Explore results from a resin lifetime study with over 150 cycles, using clarified cell harvest in every cycle, which has been performed to evaluate the alkaline stability of three protein A resins.
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rAAV Production Using HEK293 Cell Line And Transfection Medium
1/13/2023
Investigate how using a peak expression cell culture medium in the right bioreactor can promote recombinant protein production and improve the performance of a scalable AAV process.