Biosimilar App Notes & Case Studies
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Getting CMC Right For Emerging Technologies
12/20/2023
Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
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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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Tangential Flow Filtration System Coupling To Enhance Solution Offerings
3/1/2023
Discover a simple, easy, and versatile method for capsule and depth filtration of small volumes that moves research from cell harvest to purification as quickly and efficiently as possible.
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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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Recombinant Protein Purification Optimization With HIC
5/1/2023
A step-by-step high-throughput process development (HTPD) workflow to determine the optimal resin and initial conditions for hydrophobic interaction chromatography (HIC).
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Maximize Product Recovery In Bulk Filtration And Filling Flow Paths
12/15/2022
Explore a fill system designed to automate product draining and recovery within a batch to standardize processes and minimize non-recoverable hold-up within the filtration and distribution flow path sections.
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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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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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Transition To Closed Processing Systems For Cell Expansion And Banking
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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A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation
5/10/2024
Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.