Cell therapies represent an important advancement in our ability to treat difficult cancers, but continued exploration of this new modality will require new digital tools and equipment.
- PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity?
- Is Your AI Model Trustworthy And Credible In GMP Processes?
- May 2026 — CDMO Opportunities And Threats Report
- In Vivo Gene Editing Is Moving From Promise To Proof
- Why Improving Drug Delivery Remains A Major Opportunity In Oncology
- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Strategic Synthesis Of ASGCT And ASCO 2026
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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The Case For Modernizing Small-Volume Aseptic Processing
Tube welding and biosafety cabinets present significant costs and risks for small-volume aseptic processing. Modern single-use aseptic connectors offer a more efficient alternative.
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In-Line Monitoring Of Culture Medium Using Live Cell Metabolic Analyzer
Continuous in-line monitoring of glucose and lactate levels provides highly accurate, real-time data on cellular metabolism without the risks or data gaps associated with manual periodic sampling.
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Enhanced mAb Production With High-Intensity Perfusion CHO Medium
Reach new heights in mAb production with a high-intensity perfusion CHO medium designed to support consistently high product yield and quality in continuous perfusion cultures using CHO-K1 cells.
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How To Effectively Manage Local Affiliate Pharmacovigilance Outsourcing
Managing PV across dozens of markets strains even experienced safety teams. Learn about a framework that helps you maintain compliance, reduce risk, and scale confidently into new markets.
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Production And Clarification Of Lentiviral Vectors
Explore scalable processes for lentiviral vector production and clarification at the 50 L scale, utilizing the CTS LV-MAX system and single-use bioreactors for robust gene therapy manufacturing.
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Rescuing A Global Program For NDA Success
Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.
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Scale-Up Of AAV Production In Fixed-Bed Bioreactors
Consistent AAV production is critical for manufacturing. See how aligned strategies deliver comparable cell growth, metabolic trends, and rAAV5 titers from development through production.
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Challenges, Methods, And Solutions For Obtaining Optimal Starting Material
For innovative treatments like CAR-T and stem cell transplants, optimal starting material is key. Understanding collection challenges and new solutions helps ensure the best foundation for these therapies.
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T Cells In Immunotherapies: The Key Progress Underway
CAR-T therapies now make up 73% of active pipeline programs, yet solid tumors remain largely out of reach. Where is T cell immunotherapy headed next, and what does it mean for your pipeline strategy?
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Demonstration Of Scalability For A Novel Fixed Bed Reactor Platform
Designed to enable efficient scalability, a new FBR platform allows operators to use one technology, with a standardized workflow, for their process development, scale-up, and manufacturing processes.
NEWSLETTER ARCHIVE
- 06.24.26 -- What's Driving Cell & Gene Therapy Forward? Key Trends & Insights
- 06.24.26 -- Advancing CAR T For Drug-Free Remission In Autoimmune Disease With Kyverna Therapeutics' Dr. Naji Gehchan
- 06.23.26 -- STREAM Edition: Why In Vivo Therapies Are Moving Toward The Clinic With Ascidian Therapeutics' Dr. Mike Ehlers
- 06.23.26 -- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- 06.22.26 -- Navigating The Next Wave Of AAV Capsid
- 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
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
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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