US WorldMeds' expanded FDA approval for TECELRA represents another important step forward for engineered cell therapies in solid tumors.
- Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
- Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
- Building CGT Manufacturing Capacity For The Next Commercial Era
- Managing The Presence Of Visible Particulates In Cell Therapies
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
- Wondering If Your Org Should Purchase R&D Datasets?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Turnkey Dismantling, Modification, And Relocation Of A Multi-Glove Isolator SystemStrategic equipment relocation and retrofitting can reduce capital costs by fifty percent and save months in lead time. Learn how to modernize legacy systems while maintaining full GMP compliance.
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![GettyImages-1309776504-viral-inspection-laboratory-scientists]( "Streamlining AAV And LVV Manufacturing Platform Solutions")
Streamlining AAV And LVV Manufacturing Platform SolutionsObserve how streamlined, scalable platforms are transforming viral vector manufacturing to accelerate the delivery of cell and gene therapies to patients.
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![GettyImages-1463515619 home visit nurse]( "The True ROI Of Decentralized Clinical Trials")
The True ROI Of Decentralized Clinical TrialsGain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.
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Analytical Method Release And Stability Platform For RNA Drug SubstanceWe offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.
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De-Risking The Neurology IND: Lessons From Early FDA EngagementLearn how early FDA alignment can help your neurology program move forward with greater clarity, confidence, and regulatory readiness.
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Aggregation In Antibody-Drug Conjugates: Causes And MitigationDiscover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.
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High-Throughput IgG Quantification Assay For Cell Line DevelopmentMonoclonal antibodies are revolutionizing treatment for various diseases, which include cancer and autoimmune disorders. Discover how improving production methods can reduce costs and enhance accessibility.
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A Transient Cell Line To Produce rAAV With Low-Level hcDNA EncapsidationDiscover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.
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Smart Scale-Up: Expanding Viral Vectors With Microcarrier Bead TechnologyScale up your manufacturing of adherent cell cultures used for viral vector-based treatments with the novel technologies needed to facilitate safe, rapid production.
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![GettyImages-1213797500 doctor cancer patient, oncology]( "Accelerate Your Oncology Breakthroughs")
Accelerate Your Oncology BreakthroughsFinding the right partnership can help your oncology clinical trials overcome trial complexities through strategic planning, a deep scientific understanding, and operational excellence.
NEWSLETTER ARCHIVE
- 07.17.26 -- Compliance, Costs, And Site Readiness In CAR-T Clinical Trials
- 07.16.26 -- Why Fit-For-Purpose Manufacturing Is Becoming The Defining Strategy In CGT
- 07.15.26 -- Human-Centric Models For Modern Drug Development
- 07.15.26 -- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- 07.14.26 -- STREAM Edition: The Facility Master Planning Playbook With Herman Bozenhardt
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
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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