Biosimilar App Notes & Case Studies
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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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Accelerating Bulk Harvest Testing Using A CHO Animal Origin Free Virus Panel
10/19/2023
Here, we describe the design and performance of a degenerate PCR-based approach to broad virus screening that can be used in testing bulk harvest material derived from CHO cells.
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Protein L Affinity Resin Is Ready To Move To Manufacturing
7/12/2023
Discover a protein L affinity chromatography resin that is well suited for use in biomanufacturing and offers increased binding capacities compared to other resins.
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Using High Cell Density Cryopreservation For Seed Train Intensification
12/21/2022
The traditional seed train expansion process can be time consuming. Learn how seed train intensification techniques such as high cell density cryopreservation (HCDC) can accelerate and streamline the process.
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Improve Speed To Market By Mitigating Vial And Stopper Incompatibility
10/1/2024
Explore two studies that indicate for a properly-assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size or vial style.
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Determining RNA Integrity And Purity By Capillary Gel Electrophoresis
6/30/2023
To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.
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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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Lipid Nanoparticle Compositional Analysis By UHPLC-CAD
6/30/2023
Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.
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Sterilizing Grade Filter Performance With Biologic Drugs
3/11/2024
Examine the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins as well as how filter selection can impact your process.
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Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis
6/14/2024
This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.