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
-
![GettyImages-1132766141 patient recruitment]( "Recruiting & Retaining More Patients Per Site:")
Recruiting & Retaining More Patients Per Site:Through Home Trial Support (HTS) services, MRN is able to enhance the accessibility of clinical trials while reducing the emotional toll on their patients suffering from loss of mobility.
-
![Organs-body-organoid-study-GettyImages-1157550305]( "A Study To Assess Organoid Size And Cell Count From 3D Image Analysis")
A Study To Assess Organoid Size And Cell Count From 3D Image AnalysisRecent advancements in 3D patient-derived organoids (PDOs) offer improved predictive power over traditional 2D assays. Explore a patented bioprocess for PDO expansion that could revolutionize drug discovery, especially in oncology.
-
![GettyImages-1087219366-filling-vials-mechanical]( "Why Choose Robotic Processing For Small Batch Aseptic Filling")
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.
-
![GettyImages-1497705338-gloved-hand-cell-culture-dish]( "Cell Retention Technology And Specialized Cell Culture Media")
Cell Retention Technology And Specialized Cell Culture MediaExplore how perfusion technology is transforming upstream bioprocessing by boosting productivity, reducing costs, and enabling process intensification while overcoming cell retention challenges.
-
![GettyImages-1285104827-assay-plate-imaging-analysis]( "Fully Automated Cell Culture Passaging And Expansion")
Fully Automated Cell Culture Passaging And ExpansionAutomating cell culture tasks can reduce human error and free scientists from labor-intensive routines. Discover how imaging and automated systems enhance accuracy and reproducibility in cell culture processes.
-
![GettyImages-493957253 microscope]( "Factors Influencing CD34+ Cell Collection Efficiency In Leukapheresis")
Factors Influencing CD34+ Cell Collection Efficiency In LeukapheresisEfficiently collecting sufficient peripheral blood stem cells is paramount for successful transplantation, necessitating a deeper understanding of influencing factors and procedural nuances.
-
![GettyImages-2183428964 lab]( "Analytical Method Release And Stability Platform For RNA Drug Substance")
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.
-
![GettyImages-2166551611 ddPCR]( "Improving Next-Generation Sequencing Workflows With Droplet Digital PCR")
Improving Next-Generation Sequencing Workflows With Droplet Digital PCROptimize NGS workflows by using digital PCR for absolute quantification. Improve library quality, reduce bias, and gain sensitive validation for rare variants in complex genomic samples.
-
![GettyImages-1165637777 DNA]( "Analysis Of DNA Integrity And Stability Using Digital PCR")
Analysis Of DNA Integrity And Stability Using Digital PCRDigital PCR offers precise, inhibitor-resistant DNA quantification and genome integrity assessment. Discover how this method enhances accuracy and reproducibility, especially in AAV analysis, using multiplexed targets and Poisson-based calculations.
-
![GettyImages-2164415438-petri-dish-bacteria-scientist-gloved-hands]( "Monitoring Microbial Contamination Of Mammalian Cell Cultures")
Monitoring Microbial Contamination Of Mammalian Cell CulturesMammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.
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.
More Content Collections
