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.
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CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
Streamline Method Validation In Pharmaceutical Product Development
Method 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.
Leveraging Clinical Trial Data In Real Time To Effect Change And Mitigate Risk
Learn how clinical trial data gathering, contextualization, and analysis can all benefit from existing — but underutilized — technologies and resources.
Differentiation Of Human Pluripotent Stem Cells Into Cardiomyocytes
Evaluate 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.
Transforming T Cell Manufacturing Via Elutriation
This 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.
Efficient, Large-Scale Transfection Of T-Cells Using Flowfect® Technology
The 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.
Modeling The Economics Of Vaccine Manufacturing
Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
Characterize T Cell Exhaustion And Hypofunctionality In Cancer
Investigate what drives the hypofunctional state of T cells in ICB-nonresponsive cancers through the characterization of CD8+ T cell functionality in different tumor types.
Cell & Gene Therapy Company Accelerate Proprietary MSC Therapy For Covid In Less Than 6 Months
A 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.
Lipid Nanoparticle Compositional Analysis By UHPLC-CAD
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.
In-Process Media Monitoring Using LC-MS And Automated High Throughput Microbioreactor Systems
Explore 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.
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.More Content Collections