Gene therapy’s next test is not proving it works, but proving it can scale.
- Managing Supply Disruptions In ATIMP Clinical Trials
- Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge
- What Reliance, Annex 1, And AI Mean For The Future Of GMP
- Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss
- Applying Contamination Control By Design: A Practical Guide For CDMOs
- Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit
- CGT Manufacturing Shifts From Capacity To Strategy
- Rethinking CQV In A Digital, Agile Manufacturing Landscape
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-1288978528 Scientist Using Microscope In Lab]( "Simpler, Faster, Cheaper Advanced Therapy Manufacturing")
Simpler, Faster, Cheaper Advanced Therapy ManufacturingDiscover how TFDF-based perfusion technology boosts lentiviral vector production by over 10-fold, slashes costs, and accelerates the commercialization of CAR-T and other advanced cell therapies.
-
![GettyImages-1259302414 lab, research, culture]( "A Novel Cell-Based Assay For Ubiquitin Drug Discovery")
A Novel Cell-Based Assay For Ubiquitin Drug DiscoveryLearn about a novel cell-based assay that can advance ubiquitin ligase drug discovery. This high-throughput method simplifies assay development, saving time and resources.
-
![GettyImages-1441662840-lab-team-communication-collaboration]( "Accelerating Bulk Harvest Release Testing With A PCR-Based Solution")
Accelerating Bulk Harvest Release Testing With A PCR-Based SolutionAdventitious agent testing is frequently a bottleneck in downstream processing. Discover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.
-
![GettyImages-2190502074-water-filtration-laboratory]( "Innovation In Filtration")
Innovation In FiltrationFiltration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
-
![GettyImages-185246319 fluorescent DNA]( "CAR Expression Detection Using Fluorescent Labeled Proteins, Flow Cytometry")
CAR Expression Detection Using Fluorescent Labeled Proteins, Flow CytometryLearn how site-specific fluorescent labeling addresses key challenges in flow cytometry-based evaluations by enhancing assay sensitivity, reducing variability, and ensuring reliable results.
-
![GettyImages-1309776439-scientists-lab-analysis-manufacturing]( "Optimized Transient Transfection Platform: AAV Program From Gene To GMP")
Optimized Transient Transfection Platform: AAV Program From Gene To GMPAchieve faster AAV gene therapy progress by adopting a unified platform for manufacturing. Accelerate your program to GMP readiness with up to 9x higher titers and robust, high-quality full capsid yields.
-
![cell-therapy-GettyImages-1494029118]( "Expanding The Capabilities Of Targeted Integration")
Expanding The Capabilities Of Targeted IntegrationSee the demonstration of precise, site‑specific integration of a 50 kb multi‑gene construct into human iPSCs, overcoming size limits of traditional genome‑engineering approaches.
-
![GettyImages-2103894533 office, team, coworkers, meeting]( "Enhance DMC Services By Harnessing Biostatistics Expertise")
Enhance DMC Services By Harnessing Biostatistics ExpertiseDiscover how expert biostatistics and project management ensured data integrity and efficient DMC operations in a complex clinical trial for hematologic cancer cell therapies.
-
![pharma-manufacturing-reg-GettyImages-1409457755]( "USP <665> Becomes Official On May 1, 2026. Are You Ready?")
USP <665> Becomes Official On May 1, 2026. Are You Ready?With USP <665> becoming official on May 1, 2026, proactive preparation is essential to ensure compliance and prevent delays, regulatory observations, or supply chain disruptions.
-
![GettyImages-2193840525-dna-strand-viral-vector-gene-therapy]( "Advanced Sequencing Approaches For Comprehensive AAV Vector Characterization")
Advanced Sequencing Approaches For Comprehensive AAV Vector CharacterizationShort and long read sequencing offer complementary insights into AAV vector identity, integrity, and impurity profiles, helping developers improve safety, efficacy, and scalability of gene therapy products.
NEWSLETTER ARCHIVE
- 06.02.26 -- STREAM Edition: Redefining CAR-T Timing And Patient Access With Allogene Therapeutics' Dr. Zachary Roberts
- 06.02.26 -- Why the Right Manufacturing Partner Is About More Than Capacity
- 06.01.26 -- Cut Variability, Raise Titers, And Scale With Confidence
- 06.01.26 -- CGT Manufacturing Shifts From Capacity To Strategy
- 05.29.26 -- Securing Your Advanced Therapy Pipeline
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
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
