Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.
- Complete Response Letters For CGTs Share This Common Theme
- Finding The Therapeutic Window: Using Single-Cell Biology To Build More Selective T-Cell Engagers
- DEA Reveals Hidden Costs Of Analytical Validation Guidelines
- What LSPA's Life Sciences Future Says About The Road Ahead For CGT
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- CDMO Selection Beyond Capabilities And Price
- August 2026 — CDMO Opportunities And Threats Report
- ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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A Faster Path To Genomic Medicine Feasibility
Life Edit accelerates genomic medicine by comparing five editing modalities, engineering new enzymes, and rapidly pinpointing optimal strategies that boost feasibility, cut risk, and speed clinical progress.
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Enhanced Development Of Virus-Specific Hybridomas
Double-stranded DNA viruses cause various human diseases, which complicates diagnosis due to antigen conservation. Explore a cell line that produces specific monoclonal antibodies to aid biotherapeutics development.
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Advances In High-Concentration Protein Formulation Development
High-concentration protein formulations improve patient convenience but face challenges like viscosity, aggregation, and surfactant degradation. Innovative strategies optimize stability, scalability, and quality for advanced biologics development.
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Microbial Recovery And Flow Performance With Membranes
Compare membrane materials and pore sizes to assess their impact on flow rate and microbial recovery. See how fast filtration and ≥90% organism recovery offer guidance for selecting reliable membranes.
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Scaling Success: A Blueprint For Flexible Biometrics Partnerships
Learn how a micro-FSP model and integrated biometrics team can scale from specialized support to a full-service solution, ensuring agility and consistency as clinical trial needs evolve.
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12.5x Titer Boost Accelerates CAR-T Program To IND Filing
Plasmid engineering and process development boosted viral titer 12.5×, eliminating manufacturing bottlenecks and enabling an on‑time regulatory submission for the cell therapy program.
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Navigating CMC Regulation For Plasmid DNA In Gene Therapy
Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.
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Streamlining Pediatric Clinical Trials With Vestigo®
Utilizing a centralized, automated platform can eliminate the friction of manual accountability logs, ensuring audit readiness while providing real-time visibility into financial reporting.
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Redefining The Analytical Frameworks Surrounding Capsid Characterization
Modern AAV manufacturing demands precise capsid characterization to distinguish empty, partial, and full particles, as regulators now require rigorous purity and potency control for clinical safety.
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Best Practices For Analysis Of IVT mRNA
Discover how an automated capillary electrophoresis system provides robust and precise integrity, concentration, and size analysis for IVT mRNA.
NEWSLETTER ARCHIVE
- 10.15.26 -- Your Vector Is Deciding The Path Of Your Cell & Gene Therapy Program
- 10.15.26 -- Which Viral Clearance Step Delivers The Highest LRV?
- 10.15.26 -- A Sponsor's Guide To Smarter Viral Vector CDMO Partnerships
- 10.14.26 -- New Advances In Drug Safety With Human-Relevant Preclinical Models
- 10.14.26 -- Single-Use Solutions Built For Flexibility
- Inside The Next Phase In Autoimmune CAR T From Meeting On The Mesa 2026
- What LSPA's Life Sciences Future Says About The Road Ahead For CGT
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
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