Biosimilar App Notes & Case Studies
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Sterilizing Grade Filter Performance With Biologic Drugs
3/11/2024
Here, we analyze the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins and demonstrate how filter selection can impact your process.
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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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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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Next Generation Sequencing For Adventitious Agent Detection In Cell Banks
2/23/2023
NGS-based methods for agnostic broad range detection are suitable options to augment or replace current virus testing methodology. Explore a NGS AAT method for cell line characterization and more.
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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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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.
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Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage
3/24/2023
Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL
4/25/2023
A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.
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AAV Full/Empty Capsid Separation Using Mechanistic Modeling
5/1/2023
In this study, we used mechanistic modeling to investigate how AAV-resin interactions are affected when MgCl2 is used as an elution additive.
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The Use Of Injectable Packaging From Early Development To Commercialization
2/20/2024
While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.