Following the FDA approval of TREGZI, Orca Bio's precision engineered allogeneic cell therapy is redefining stem cell transplantation through improved immune control, advanced manufacturing, and a platform designed to expand the future of cell therapy.
- Wondering If Your Org Should Purchase R&D Datasets?
- Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
- Organizing Digital Systems Around Novel Modalities
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Fast And Sensitive Mycoplasma Detection Workflow
Digital PCR enables fast, sensitive mycoplasma detection in cell-based products. Explore how this pharmacopeia-compliant workflow improves accuracy, reduces delays, and supports reliable decision-making.
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Extractables In Single-Use Systems Used In ADC Manufacturing
To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.
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Optimized Urine Liquid Biopsy Workflow
Urine-derived cell-free DNA is revolutionizing liquid biopsy research to offer a non-invasive, accessible tool for early disease detection, monitoring, and comprehensive diagnostics across oncology.
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Enhanced Validation Data Anti-EGFRvIII Recombinant Antibody
Select the right antibody clone by exploring enhanced validation data for top recombinant antibody clones that offer comprehensive specificity and sensitivity insights tailored to your project's unique requirements.
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Why Membrane Matters In AAV Filtration
Gene therapy is revolutionizing medicine to offer one-time treatments. Find out how AAV vectors are leading the way to optimize production and make these life-changing therapies accessible.
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Efficient Protein Purification Strategies
Examine two rapid, high‑throughput strategies for small‑scale protein separation, using either multimodal resins or ion exchange membranes to achieve efficient, low‑volume purification.
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Biocompatibility Studies On CHO Cell Culture In X-ray Irradiated BioBLU® Single-Use Bioreactors
In cell culture, the leakage of toxic or inhibitory chemicals from single-use bioreactors has become a growing concern. Explore recommendations for leachable studies.
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Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered Success
The commercialization of cell and gene therapies requires a precise and resilient logistics model that can adapt to rapid demand and global expansion while maintaining a patient-first approach.
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Comparing Sterility Testing Techniques
Is your sterility testing process hindering your product release? Discover how the right approach can streamline your process, reduce false positives, and ultimately save you time and money.
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Form Fill And Seal Label Applicator For Drug Packaging
Discover a solution that ensures particularly efficient and reliable vertical and horizontal form fill and seal machine labeling.
NEWSLETTER ARCHIVE
- 07.09.26 -- From Clone To Commercial: Redefining Cell Therapy Workflows
- 07.09.26 -- Applying Contamination Control By Design: A Practical Guide For CDMOs
- 07.08.26 -- Why In Vivo Therapies Are Moving Toward the Clinic with Ascidian Therapeutics' Dr. Mike Ehlers
- 07.07.26 -- Targeting Tau In Alzheimer's Disease With Voyager Therapeutics' Al Sandrock, M.D., Ph.D.
- 07.07.26 -- AI Has Arrived In Biotech CMC Amid Patchwork Governance
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
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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