Here's why scaling MSC therapies requires maintaining product consistency, potency, and comparability as manufacturing evolves.
- In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
- Why You Should Measure Comparability Debt Before Ever Starting A Study
- What FDA Inspectors Want From Your OOS File
- You Can't CAPA What You Can't Classify
- New USP Guidelines, Standards Address Lentivirus Characterization
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Bringing Next-Gen Sequencing To GMP Scale
- Risk Managing Through The Void Of ATMP Visible Particle Guidance
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Boosting CMC Regulatory Efficiency In Gene Therapy
Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.
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Improved Sensitivity In Flow Cytometry By In-Line Pre-Enrichment
Tracking rare immune cells is no longer limited by conventional flow cytometry sensitivity. Learn how integrated pre‑enrichment strategies enable reliable detection and improved quantification.
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Strengthening cIEF Method Validation With cIEF-MS
Preparing for method validation, a biopharma company needed to characterize cIEF charge variants and confirm peak identities for regulatory readiness.
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mRNA Purification Using Anion Exchange Chromatography At Ambient Temperature
Explore how anion exchange chromatography with dual gradient elution enables efficient mRNA purification at ambient temperature.
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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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Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals
Explore how digital solutions help streamline mRNA manufacturing by reducing costs, improving efficiency, and supporting sustainability by creating paperless processes for emerging therapeutics.
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Automating The Process Of Filling Media Into Bottles
Learn how a vaccine manufacturer using a wide range of containers for media and buffer filling was able to increase efficiency by 70% with an automated closed-system solution.
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Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies
Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.
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Developing A Robust Crystallization Process For A High-Molecular-Weight Peptide
Scaling peptide crystallization is complex, with solid forms, polymorphic impurities, and solvent constraints all impacting quality and manufacturability.
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Functional Characterization Of 3D Assembled Neurospheres
Neural organoids and 3D spheroids offer advanced platforms for brain research and drug discovery. Discover how creating 3D neurospheres from iPSC-derived neurons and astrocytes aids in compound profiling and toxicity testing.
NEWSLETTER ARCHIVE
- 09.25.26 -- The Promise Of MRD-Guided CAR-T Treatment
- 09.24.26 -- OPCU Special CPHI Session: Trends Shaping Advanced Therapies
- 09.24.26 -- The Unspoken Truth About Cell Therapy Product Understanding
- 09.23.26 -- Europe's ATMP Opportunity Still Requires Local Navigation
- 09.22.26 -- How Regeneron Navigates Early Cell And Gene Therapy Quality Risks
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- In Vivo CAR T Needs More Than Better Cell Engineering
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