Biosimilar App Notes & Case Studies
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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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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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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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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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Natural Killer Cells Manufacturing
7/22/2022
Follow the feasibility of xeno‑free NK cell expansion, closure of key unit operations, and how future work could focus on fine‑tuning each step to generate a robust, scalable process.
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Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges
7/21/2023
Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing could solve three of these key challenges regarding instrumentation.
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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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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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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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AAV Process Intensification Using High Salt Lysis And Salt Tolerant Endonuclease
3/25/2024
In the production of adeno-associated virus (AAV) vectors, cell lysis involves challenges addressed through high salt concentrations and a salt-tolerant endonuclease, enhancing titer and infectivity.