Few topics introduced by Annex 1 have generated as much discussion as pre-use post-sterilization integrity testing (PUPSIT). I share key considerations for cell and gene therapies.
- In Vivo Gene Editing Is Moving From Promise To Proof
- Why Improving Drug Delivery Remains A Major Opportunity In Oncology
- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Strategic Synthesis Of ASGCT And ASCO 2026
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
- A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1002000796-lab-research-scientist-development]( "Comprehensive And Streamlined Genomic Signature Assessment")
Comprehensive And Streamlined Genomic Signature AssessmentSimultaneous analysis of HRD, TMB, and MSI offers a more complete view of tumor biology. A modular sequencing approach enables efficient workflows, conserves samples, and delivers deeper insights.
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![GettyImages-1347856166 tube, research, lab]( "Overcoming Scale-Up Challenges In iPSC Production: A Joint Investigation")
Overcoming Scale-Up Challenges In iPSC Production: A Joint InvestigationDiscover how new processing methods tackle challenges in large-scale stem cell production and how automated, low-shear processing maintains cell health and pluripotency across production scales.
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![Funnel]( "How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab Workflows")
How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab WorkflowsThe repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of the same movements over and over, which can take a toll on hands, wrists and shoulders and ultimately can lead to serious damage. Choosing the right tools can make all the difference.
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![GettyImages-2187764040-cell-culture-testing-manufacturing-in-lab]( "Smart Scaling For Cell And Gene Therapies")
Smart Scaling For Cell And Gene TherapiesTo meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.
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![dna, rna molecules-GettyImages-537327406]( "Optimize DNA Clearance In High-Salt, GMP-Grade Purification Processes")
Optimize DNA Clearance In High-Salt, GMP-Grade Purification ProcessesEfficient hcDNA removal is vital for therapeutic safety and compliance. Discover how salt-active enzymes support high-salt purification workflows to help manufacturers meet strict regulatory standards.
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![GettyImages-931182764 Cheerful Office Workers On Laptops]( "Reframing Clinical Vendor Selection")
Reframing Clinical Vendor SelectionExplore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.
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![early-oncology-trials-GettyImages-1796958784]( "Successful SwissMedic Marketing Authorization Application For An Oncology Therapy")
Successful SwissMedic Marketing Authorization Application For An Oncology TherapySee how strategic EU dossier adaptation and Swiss-specific regulatory expertise enabled a successful SwissMedic submission and accelerated market access for an oncology therapy.
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![GettyImages-675822742 bioreactor]( "Addressing The Challenges In Lentivirus Harvest Clarification")
Addressing The Challenges In Lentivirus Harvest ClarificationTraditional depth filtration struggles with lentiviral harvest clarification, leading to low yields and high costs. However, single-use centrifugation offers a promising alternative.
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![GettyImages-2181934436-laboratory-analysis-scientists-technology-computer]( "Streamline Analytical Tech Transfer Through Analytical Target Profile")
Streamline Analytical Tech Transfer Through Analytical Target ProfileAnalytics debt in CGT can derail timelines and budgets. Learn how early ATP planning and cross-functional alignment can eliminate costly setbacks and accelerate IND approvals.
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![GettyImages-614242432-petri-dish-micro-organisms-bacteria]( "Prevent The Risk Of Cross-Contamination With Microbial Colony Pickers")
Prevent The Risk Of Cross-Contamination With Microbial Colony PickersExplore a microbial colony picker that streamlines lab workflows to ensure rapid and accurate genetic library screening. Key features include UV sanitization, pin washing, and halogen drying, which meets GMP standards.
NEWSLETTER ARCHIVE
- 06.19.26 -- Redefining CAR-T Timing And Patient Access With Allogene Therapeutics' Dr. Zachary Roberts
- 06.18.26 -- Tools And Technologies Enabling Next-Generation Cell Therapies
- 06.18.26 -- Scale Vaccine Production With Proven Cell Culture Solutions
- 06.18.26 -- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
- 06.17.26 -- What's Slowing Your Cell & Gene Therapy Program?
- In Vivo Gene Editing Is Moving From Promise To Proof
- 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
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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