Adeno-associated virus (AAV) gene therapies that are designed to deliver a therapeutic transgene to patients are complex products that can be challenging to manufacture. Because of their complexity, a variety of analytical methods are required to ensure that these viral vectors are of high quality and purity, will function as intended, and have batch-to-batch consistency.
- Your 6 Priority Areas For A Successful 2024
- Biotech Dealmaking With Regeneron's Nouhad Husseini
- Gene Therapy Deals, Collaborations, & Partnerships With Astellas' Richard Wilson
- Achieving Flexibility In RNA Drug Manufacturing With Microfluidics
- Backpacks And Biotech With Luke Timmerman
- A Brief Introduction To Environmental Monitoring For Startups
- Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
- 3 Steps For Cell & Gene Therapy Medical Affairs Teams To Provide Strategic Value
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Scientist laboratory ipad GettyImages-585776870]( "Streamline Method Validation In Pharmaceutical Product Development")
Streamline Method Validation In Pharmaceutical Product DevelopmentMethod validation is a time-consuming activity prone to human error. Find out how a method validation manager can provide a single, comprehensive solution for your validation activities.
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![your-path-to-decentralized-clinical-trials-0001831902058]( "Leveraging Clinical Trial Data In Real Time To Effect Change And Mitigate Risk")
Leveraging Clinical Trial Data In Real Time To Effect Change And Mitigate RiskLearn how clinical trial data gathering, contextualization, and analysis can all benefit from existing — but underutilized — technologies and resources.
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![Cryopreservation GettyImages-172640159]( "Differentiation Of Human Pluripotent Stem Cells Into Cardiomyocytes")
Differentiation Of Human Pluripotent Stem Cells Into CardiomyocytesEvaluate key performance data of a cell culture process that enables the expansion and differentiation of human pluripotent stem cells (PSCs) in a closed and automated system.
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![Invetech]( "Transforming T Cell Manufacturing Via Elutriation")
Transforming T Cell Manufacturing Via ElutriationThis study compares a standard T cell manufacturing process starting with a conventional apheresis wash with a process starting with Korus lymphocyte elutriation. We demonstrate the Korus platforms ability to reduce manufacturing variability by elutriating lymphocytes from apheresis, providing a more consistent cell product for downstream manufacturing.
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![GettyImages-1434150674-lab-microscope-team]( "Efficient, Large-Scale Transfection Of T-Cells Using Flowfect® Technology")
Efficient, Large-Scale Transfection Of T-Cells Using Flowfect® TechnologyThe objective of this study was to test transfection of T-cells with GFP mRNA for evaluation of cell viability, transfection efficiency, and post-transfection growth using Kytopen’s Flowfect® technology.
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![Vaccine Manufacturing GettyImages-1384850913]( "Modeling The Economics Of Vaccine Manufacturing")
Modeling The Economics Of Vaccine ManufacturingHere, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
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![GettyImages-963804760-t-cell-cancer-cell]( "Characterize T Cell Exhaustion And Hypofunctionality In Cancer")
Characterize T Cell Exhaustion And Hypofunctionality In CancerInvestigate what drives the hypofunctional state of T cells in ICB-nonresponsive cancers through the characterization of CD8+ T cell functionality in different tumor types.
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![COVID Close Up]( "Cell & Gene Therapy Company Accelerate Proprietary MSC Therapy For Covid In Less Than 6 Months")
Cell & Gene Therapy Company Accelerate Proprietary MSC Therapy For Covid In Less Than 6 MonthsA biotechnology company needed a partner to help them develop their new MSC therapy as quickly as possible. Read how an off-the-shelf hMSC manufacturing ecosystem accelerated their product development.
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Lipid Nanoparticle Compositional Analysis By UHPLC-CAD")
Lipid Nanoparticle Compositional Analysis By UHPLC-CADExplore 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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![GettyImages-1209661942-lab-data-analysis-development]( "In-Process Media Monitoring Using LC-MS And Automated High Throughput Microbioreactor Systems")
In-Process Media Monitoring Using LC-MS And Automated High Throughput Microbioreactor SystemsExplore a comprehensive LC-MS methodology, workflow, and batch analysis software that allows bioprocessing engineers to quickly and easily run and process large number of samples.
NEWSLETTER ARCHIVE
- 11.30.23 -- Overcome Downstream Bottlenecks In LVV Production
- 11.30.23 -- Accelerating Process And Analytical Development Timelines For Cell And Gene Therapies
- 11.30.23 -- How To Move mRNA Forward
- 11.29.23 -- Ensure The Development And Production Of Safe, Scalable, And Efficacious mRNA Products
- 11.29.23 -- Upstream Decisions That Ensure Downstream Success
- Video Clips From Cell & Gene Live: Optimizing Your Cold Chain For Cell Therapies
- A Sneak Peek At Providence Therapeutics On Cell & Gene: The Podcast
- Vor Bio Shares Progress For Patients with AML
- The Eye: A Candidate For Modifier Gene Therapy
- Video Clips From Cell & Gene Live: Regulating The CGT Workflow To Improve Patient Safety
CELL AND GENE CONTENT COLLECTIONS
While there are opportunities to scale, there are also manufacturing gaps, capacity issues, and production timelines that require improvement to do so. And then, of course, there’s cost. Because scale up and scale out are significant to everyone in the sector, we’ve curated insightful editorial that addresses the most important aspects of scalability.
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