Sana Biotechnology and Mayo Clinic are partnering to standardize delivery of a one-time hypoimmune cell therapy, aiming to scale access and redefine care for type 1 diabetes.
- FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
- Validating Candel's BLA-Ready Analytics Profile
- Mapping Candel Therapeutics' Sprint To The BLA Finish Line
- Why Cell And Gene Therapies Break After Early Success
- AI, Digitalization, And In Vivo Programming Redefine Cell And Gene Therapy
- Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Why A Cell Therapy CEO Waited Until Phase III To Outsource
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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hiPSC Aggregate Expansion In Stirred-Tank Bioreactors
Learn about a bioreactor-based Human Induced Pluripotent Stem Cell (hiPSC) expansion workflow with the potential to improve cell therapy applications.
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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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Oligonucleotide Purification And Synthesis
Examine how a 21‑mer oligo was synthesized and purified through systematic resin screening, method optimization, and successful scale‑up to build reliable, high‑purity chromatography workflows.
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Reducing The Burden Of Patient Retention And Improving Continuity
Immunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.
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A Risk-Based Approach To Plasmid DNA And mRNA Process Development
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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Co-Precipitation Of Metal Carbonate Templated Protein Microparticles
Explore the automated production of protein microparticles using an innovative method that offers a standardized and scalable solution for co-precipitation in biopolymer particle fabrication.
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Solve ATMP Aseptic Filling Challenges With Gloveless Isolators
Human intervention is the top contamination risk in ATMP manufacturing. Robotic gloveless isolators address that risk through full automation and real-time monitoring during aseptic filling.
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Smart Manufacturing: A Strategic Imperative For Pharma's Future
Pharmaceutical manufacturing is evolving rapidly. Find out how digital technologies like AI, digital twins, and software-defined automation are driving smarter, more agile production.
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Raise Your Standards With Downflow Booth Airflow Containment
Ensure personnel safety during hazardous material handling by mastering airflow dynamics and containment screens. Learn to achieve low exposure levels through advanced HEPA filtration methods.
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Rethinking Peptones As First-Line Optimization Tools
Peptones enhance CHO cell growth, viability, and yield, offering a fast, low-risk way to improve bioprocess performance without major process changes.
NEWSLETTER ARCHIVE
- 04.28.26 -- What FDA CRLs Reveal, USP <665> Countdown, Biowaiver Webinar
- 04.28.26 -- Target Selection Drives The Future Of CAR-T Therapy In Solid Tumors
- 04.28.26 -- STREAM Edition: Advancing Early Detection In Rare Cancers with Catriona Jamieson, M.D., Ph.D.
- 04.27.26 -- March 2026 — CDMO Opportunities And Threats Report
- 04.25.26 -- Why A Cell Therapy CEO Waited Until Phase III To Outsource
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Target Selection Drives The Future Of CAR T Therapy In Solid Tumors
- Mitigating Challenges In Solid Tumor Delivery
- Ensuring Quality Of CGT Materials
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