Biosimilar App Notes & Case Studies
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Simplifying CHO Cell Line Genetic Stability Testing
4/11/2024
Here, we describe the use of whole genome sequencing to perform a comprehensive assessment of genetic stability in clonally derived CHO cell banks using the Aptegra™ CHO genetic stability assay.
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Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines
3/24/2025
Discover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.
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Process Validation Considerations
6/13/2024
Process validation is a crucial step for successful registration and commercial manufacturing. Learn how to determine the right timing and properly apply a risk-based approach.
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Accelerating The mAb Formulation Process
5/7/2024
Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.
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Optimizing TFF And SPTFF For High-Concentration mAb Formulations
4/9/2025
Discover the critical role of formulation buffer composition in stabilizing monoclonal antibodies during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.
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Raman As A Quality Control Tool For Cell Culture Media Preparation
6/14/2024
Explore study results demonstrating how Raman technology easily differentiates between media with similar compositions and detects potential preparation errors that other analysis methods might miss.
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CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics
4/28/2025
CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.
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Monitoring Bioprocesses In A Light Environment Using Raman Spectroscopy
6/14/2024
Discover an advanced solution to facilitate the implementation of Raman technology at both laboratory and manufacturing scales in a normal light environment.
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Lentiviral Vector Production Using Single-Use Bioreactors
5/6/2024
Here, we outline a scalable and robust upstream process developed for LVV production of HEK293T cells and demonstrate how to expand HEK293T suspension cells.
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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.