Manufacturing chimeric antigen receptor (CAR) T-cell therapies is a costly and complicated process. Interius BioTherapeutics is on a mission to reduce this complexity and get these therapies to patients faster — by manufacturing CAR cells in patients' bodies.
- How CSL Behring Worked With EMA/FDA To Develop Hemgenix Potency Assays
- Breaking Down The FDA Draft Guidance, "Rare Diseases: Considerations For The Development Of Drugs And Biological Products"
- 9 Common Tech Transfer Pitfalls To Avoid
- Rocket Pharma's Modality-Agnostic Approach To Rare Disease
- Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation
- Uncovering Cell Culture Media's Part In Latest Biopharma Trends
- Extended GCP Training Is A "Must" For Cell And Gene Therapy Clinical Trials
- 5 Recommendations To Maximize CSV/CSA Outcomes
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Understanding Potency In Gene Therapy Development
Explore the importance of understanding potency in cell and gene therapy (CGT) development and the challenges in developing potency assays for CGT products.
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Alkaline Stability Of Fc And VH3 Binding In Protein A Resins
In this study, we looked at how different antibody binding sites of a protein A ligand are affected by cleaning in place (CIP).
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Large Volume Tris And DPBS Buffer Preparation
Explore a solution for efficiently mixing sinking powders that tend to accumulate on the bottom and in the corners of the bag.
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How Takeda Streamlines Assay Transfer And Troubleshooting
When one of Takeda’s quality control facilities wanted to improve assay success rates by reducing liquid handling variability, they turned to the Artel MVS® to help their assay process.
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
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Optimizing And Intensifying ADC Aggregate Removal With A DoE Approach
This study explores the feasibility of using single-use chromatography membrane technology as an alternative to resin-based chromatography in an ADC process.
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Cystic Fibrosis: Global Clinical Trial Landscape (2024)
Gain valuable insights on patient enrollment, site selection, and navigating global regulatory landscapes tailored to rare diseases, thus propelling forward CF research and treatment.
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Rapid, Seamless Upstream Process Development And Scale-Up For CHO-K1 Cells
Accelerate your biotech company's scale-up process while delivering consistent and strong cell growth, productivity, and product quality.
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Developing A Large-Scale Tangential Flow Filtration Process
Discover a process that can be modified to fit your downstream process and serves as a complete solution for concentration and diafiltration.
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ISO 21973: How To Ensure Full Compliance Throughout Every Step Of The Journey
Learn how ISO 21973, a vital standard for ensuring safe and reliable transport of cell and gene therapies, enhances supply chain efficiency and mitigates risks for the regenerative medicine industry.
NEWSLETTER ARCHIVE
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- Breaking Down The FDA Draft Guidance, "Rare Diseases: Considerations For The Development Of Drugs And Biological Products"
- Regulatory T Cells & Autoimmune Disease
- What Are Smart mRNAs?
- mRNA Delivering Full-length Dystrophin for DMD
- New Report Solidifies Greater Philadelphia Region as Global CGT Leader
CELL AND GENE CONTENT COLLECTIONS
![23_05_CG_CGTherapies_eBook_300x200 23_05_CG_CGTherapies_eBook_300x200](https://vertassets.blob.core.windows.net/image/cc64fb6e/cc64fb6e-c5e8-478b-97fb-a84deb0f9edb/23_05_cg_cgtherapies_ebook_300x200.png)
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