Biosimilar App Notes & Case Studies
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Generating A Robust Host Cell Line For A Cell Line Development Platform
11/14/2022
Learn how cell performance within the context of the cell line development workflow was confirmed with the successful isolation of stable, high-producing clones from three model monoclonal antibodies.
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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 can could solve three of these key challenges regarding instrumentation.
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Apheresis Variability Control In Cell Therapy Manufacturing
7/25/2022
Explore our best practices for apheresis collection and obtention of enriched product for cell therapies.
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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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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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Outsourcing Process Dev: Key Considerations For Biopharma
3/14/2022
In Best Practices for Outsourcing Process Development, a panel of experts discussed four themes that may help drive the best outcomes when vetting process development service providers.
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Transition To Closed Processing Systems
10/12/2022
Learn about one facility's transition to closed processes for the expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.
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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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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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In-House Manufacturing: Key To Driving A Diabetes Vaccine?
1/28/2022
Increasing constraints on today’s supply chain from the COVID-19 pandemic mean drug companies must secure strategies that can ensure product delivery in the face of these challenges.