Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.
- The Missing Layer: Why CAR-T Needs AI As Its Connective Tissue
- Building A Self-Driving Lab For LNP Development
- Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- Addressing The Particulate Challenge In Cell Therapy Products
- Let's Stop Treating Allogeneic Cell Therapy As One Thing
- Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
- Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Targeted Gene Therapies, AI-Powered Genomic Analysis-GettyImages-2196602729]( "How A QMS Embeds Quality Into Cell Therapy Production")
How A QMS Embeds Quality Into Cell Therapy ProductionDiscover how a digital manufacturing solution helped a cellular therapy leader eliminate cleanroom paper, align quality teams, and accelerate batch release times by nearly 50%.
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![240327_BMJ1L8A6473]( "Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges")
Leveraging Single-Use Solutions To Solve Working Cell Bank ChallengesDiscover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.
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![GettyImages-1341292033-tablet-cleanroom-equipment-protective-gloves]( "Cleanroom Recovery. Proven Results. Contamination Control Case Studies")
Cleanroom Recovery. Proven Results. Contamination Control Case StudiesThrough this collection, review how a proven, automated solution can help facilities stay compliant, operational, and protected — whether in a crisis or during planned maintenance.
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![GettyImages-109727565 mold]( "Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination")
Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-DecontaminationLearn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.
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![mRNA GettyImages-1356994684]( "Best Practices For Analysis Of IVT mRNA")
Best Practices For Analysis Of IVT mRNADiscover how an automated capillary electrophoresis system provides robust and precise integrity, concentration, and size analysis for IVT mRNA.
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![GettyImages-2190227882-male-scientist-lab]( "Native RPLC For ADCs: How Column Hydrophobicity Shapes DAR Separation")
Native RPLC For ADCs: How Column Hydrophobicity Shapes DAR SeparationADC characterization does not have to be overwhelmed by complex intact MS profiles. Smart column selection can improve separation, clarify critical quality attributes, and make ADC analysis easier.
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![GettyImages-2190227480-laboratory-scientists-computer-equipment-research]( "Automation Of 3D Intestinal Organoids Culture")
Automation Of 3D Intestinal Organoids CultureGain insight into how 3D organoids promise better disease modeling and drug screening and how challenges like assay complexity, reproducibility, and scalability hinder their widespread adoption in drug discovery.
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![GettyImages-2213157127-drug-formulation-discovery-pipette-liquid-vial]( "Nucleic Acid-LNP Ultrafiltration And Diafiltration")
Nucleic Acid-LNP Ultrafiltration And DiafiltrationDownstream filtration can make or break LNPs at scale. See how membrane format, loading, and shear affect recovery and stability — and how alternative TFF lowers scale‑up risk.
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![GettyImages-1087219526-scientist-computer-screen-compliance-sterilization]( "What Pharmacies Often Miss In USP <800> Compliance")
What Pharmacies Often Miss In USP <800> ComplianceMaster USP <800> compliance by transitioning from standalone equipment to an integrated system design. Review key protocols for a multi-layered strategy to mitigate cumulative drug risks.
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![3P Innovation - DPI]( "Optimizing DPI Production: Filling Technologies For Precision And Performance")
Optimizing DPI Production: Filling Technologies For Precision And PerformanceDeveloping effective dry powder inhalers requires expertise across multiple disciplines, from particle engineering and device technology to manufacturing science and regulatory knowledge.
NEWSLETTER ARCHIVE
- 07.24.26 -- Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
- 07.23.26 -- CGT Biotech/CDMO Transparency & Core Capabilities
- 07.22.26 -- Accelerate Your Gene Therapy Pipeline with NGS, AAV Clearance, and Virus Bank Expertise
- 07.22.26 -- Wondering If Your Org Should Purchase R&D Datasets?
- 07.21.26 -- STREAM Edition: How To Match CGT Manufacturing Models To Pipeline Needs
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- 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
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
