When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.
- 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
- Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases
- The Promise Of MRD-Guided CAR-T Treatment
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Antibody drug conjugates ADCs GettyImages-1715913285]( "Extractables In Single-Use Systems Used In ADC Manufacturing")
Extractables In Single-Use Systems Used In ADC ManufacturingTo 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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![GettyImages-2174865907 workflow, lab, cell therapy]( "Manufacturing Strategies To Industrialize Autologous Therapies")
Manufacturing Strategies To Industrialize Autologous TherapiesDiscover how a systematic approach to autologous cell therapy manufacturing can reduce costs, improve reliability, and accelerate access to life-changing treatments.
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![GettyImages-1323467662 data, meeting, strategy]( "Don't Let Distribution Derail Your CGT Launch")
Don't Let Distribution Derail Your CGT LaunchOvercoming distribution challenges is critical for the success of cell and gene therapies. Learn how to build a flexible, robust strategy to optimize patient access.
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![GettyImages-1412800224-scientist-examining-filter-in-lab]( "Sterile Filter Membrane Selection For Cell Culture Media Filtration")
Sterile Filter Membrane Selection For Cell Culture Media FiltrationMembrane design and filtration capacity affect pressure, throughput, and scale-up. See how comparative testing reveals opportunities to reduce required filtration area, capsule use, and changeouts.
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![GettyImages-1321031388 t cell]( "Developing CAR T Therapies With A Cell Therapy Manufacturing Platform")
Developing CAR T Therapies With A Cell Therapy Manufacturing PlatformAdvances in CAR T cell engineering are expanding clinical potential, but manufacturing complexity limits scale. Integrated, automated workflows offer a path to consistent and efficient production.
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![GettyImages-2189362114-recombinant-protein-structure]( "Comparing Process Development Approaches For Recombinant Proteins")
Comparing Process Development Approaches For Recombinant ProteinsExplore how adding a traceless tag enables streamlined affinity purification for recombinant proteins, and how this approach compares with a conventional process in development time, recovery, and purity.
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![Corning - closed system]( "How To Take Your Process To A Closed System")
How To Take Your Process To A Closed SystemUnderstand the critical considerations for implementing closed systems in bioproduction, from vessel selection to workflow customization for optimal efficiency and safety.
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![GettyImages-1068004492 women]( "Decentralized And Community-Based Solutions Driving Women's Healthcare")
Decentralized And Community-Based Solutions Driving Women's HealthcareClinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
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![GettyImages-2187764040-cell-culture-testing-manufacturing-in-lab]( "Flexible Cell Culture Media For High Titer Production Of AAV In HEK 293")
Flexible Cell Culture Media For High Titer Production Of AAV In HEK 293To maximize the results of viral titer and full capsids, it's necessary to undertake systematic process development and optimization of AAV production. The choice of cell culture medium is foundational.
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![GettyImages-1356993441 mRNA]( "Enhancing Safety And Efficacy Of mRNA-Based Therapeutics")
Enhancing Safety And Efficacy Of mRNA-Based TherapeuticsDiscover how Codex® HiCap RNA Polymerase optimizes mRNA yield while reducing dsRNA byproducts for safer, more effective therapeutics.
NEWSLETTER ARCHIVE
- 09.16.26 -- Strategies To Boost Yield, Speed IND Timelines, And Scale AAV Manufacturing
- 09.16.26 -- Novel Approach To Cancer Explores Severing Its Genetic Supply Line
- 09.15.26 -- Consequences Of Environmental Residues In Cleanrooms
- 09.15.26 -- Fixing AAV Recovery With Siren Biotechnology's Nathalie Clément, Ph.D.
- 09.15.26 -- Managing The Presence Of Visible Particulates In Cell Therapies
- 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
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
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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