REVTORPYK's FDA approval highlights the broader push toward precision therapies that address complex disease biology, overcome resistance, and deliver more durable patient benefit.
- Overcoming Recovery Challenges In AAV Production
- In Vivo CAR T Needs More Than Better Cell Engineering
- Enzyme Activity As A Surrogate Potency Marker In Cell Therapy
- Implementing And Optimizing Your eQMS
- Novel Approach To Cancer Explores Severing Its Genetic Supply Line
- Choosing Analytical Technologies At The Right Stage Of Development
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
- Unlocking The Future Of Cell And Gene Therapies
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Microbial Recovery And Flow Performance With Membranes
Compare membrane materials and pore sizes to assess their impact on flow rate and microbial recovery. See how fast filtration and ≥90% organism recovery offer guidance for selecting reliable membranes.
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Enabling Market Access As CGTs Reach More Patients
Bringing potentially curative cell and gene therapies to more patients requires a focused approach to market access. Discover essential insights into payer dynamics, pricing innovations, and treatment evolution.
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Confident Sialic Acid Identification With MS/MS
Traditional mass spectrometry left uncertainty around potentially immunogenic glycans. Learn how a biologics developer achieved regulatory-ready clarity.
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Simplify Process Scale-Up With An Innovative Single-Use Bioreactor
Consistent cell growth and protein yields from 5 L to 5,000 L show how a unified bioreactor design can simplify scale-up, reduce risk, and accelerate upstream process development in bioproduction.
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Delivering Critical Therapies With Speed And Safety
Faster approvals depend on treating regulation as part of development, not the finish line. See how early quality planning and strong agency communication can move therapies toward patients sooner.
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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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Tackling CGT Challenges: Stirred-Tank Bioreactors For R&D And Commercial Manufacturing
Scalability remains a key bottleneck in CGT manufacturing. See how optimized stirred-tank bioreactor systems accelerate translation from clinical to commercial production.
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Addressing The Challenges In Lentivirus Harvest Clarification
Traditional depth filtration struggles with lentiviral harvest clarification, leading to low yields and high costs. However, single-use centrifugation offers a promising alternative.
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What Is Size Exclusion Chromatography (SEC)?
Aggregation can compromise mAb quality at many stages of development. Learn why size exclusion chromatography is a trusted approach for detecting aggregates and supporting confident characterization.
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Pushing The Boundaries Of Chromatographic Separation
Metal-sensitive analytes often suffer from poor recovery and distorted peak shapes. Learn how inert hardware improves sensitivity and chromatographic performance for challenging analyses.
NEWSLETTER ARCHIVE
- 08.27.26 -- Meeting Modern Challenges In Ophthalmic Drug Delivery
- 08.26.26 -- Optimizing Cold Chain & Cryo Logistics
- 08.26.26 -- Clinical Success Of Combination Cell Therapy Hinges On Manufacturability
- 08.25.26 -- OPCU: Advancing Large Molecule Programs Through Smarter Fill-Finish Planning
- 08.25.26 -- Why Vector Yield Remains The Biggest Bottleneck In Vivo Gene Therapy
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- In Vivo CAR T Needs More Than Better Cell Engineering
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
- Solving Vector Yield Challenges Starts Long Before Manufacturing
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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