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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Data-Driven CHO Bioprocess Optimization And Scale-UpLearn how at-line cell culture media analysis enhances mAb production by refining nutrient feed strategies, reducing toxic metabolites, and improving yields while lowering costs.
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A Journey To Boundless Automation In Life SciencesBoundless automation reimagines industrial computing through seamless integration of the intelligent field, edge, and cloud, unified by a real-time data fabric that enables digital transformation.
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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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Why Choose Robotic Processing For Small Batch Aseptic FillingReducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.
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Case Study: The Right Ratio – Building An End-To-End DAR Strategy For ADC SuccessWhen developing antibody-drug conjugates (ADCs), a robust drug-to-antibody ration (DAR) strategy isn’t just nice to have — it's mission-critical.
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Top Questions Before You Buy A Hazardous Pharmacy Compounding IsolatorMove beyond brochure specifications for hazardous compounding. Learn the critical airflow, structural, and pressure requirements needed to ensure long-term facility safety.
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Advances In Flow-Through Technology To Enhance mAb PolishingOptimize your monoclonal antibody purification with cutting-edge flow-through chromatography. Learn how POROS resins enhance polishing efficiency, improve aggregate removal, and streamline bioprocessing.
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Development Of Allogeneic CAR T Cells As A Potential Therapy For Acute Myeloid LeukemiaDiscover how enabled development of allogeneic CAR T-cells offers a promising, off-the-shelf therapy approach for acute myeloid leukemia.
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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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Unlocking Durable Allogeneic Cell TherapyAdvances in genome engineering and immune evasion are enabling scalable, durable allogeneic cell therapies, overcoming rejection challenges and expanding potential treatments across diverse diseases.
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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