By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
- CDMO Selection Beyond Capabilities And Price
- August 2026 — CDMO Opportunities And Threats Report
- ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Building Sustainable Biopharma Supply Chains Starts With Procurement
- Sustainable Facility Design Brings Bayer Instant Savings
- In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
- Why You Should Measure Comparability Debt Before Ever Starting A Study
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Drug Development Plan Explained: DPP Templates And Examples
Only 6.7% of Phase 1 drugs reach approval. A well-structured Drug Development Plan (DDP) can meaningfully improve your odds — learn exactly how to build one.
-
Vial Adapter Transfer Device Compatibility With Cell Therapies
Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.
-
Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ
The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.
-
When To Consider Material And Personnel Airlocks For Downflow Booths
Strategic use of airlocks in downflow booth design enhances pressure stability and containment. A risk-based approach ensures facility integration meets rigorous safety and compliance standards.
-
Building A Scalable Global T Cell Manufacturing Platform
Achieve scalable T cell manufacturing with automation, standardized workflows, and integrated quality control to enable high-yield production, flexible scheduling, and seamless tech transfer.
-
Oligonucleotide Purification And Synthesis
Examine how a 21‑mer oligo was synthesized and purified through systematic resin screening, method optimization, and successful scale‑up to build reliable, high‑purity chromatography workflows.
-
Cytokines For Ex Vivo Cell Culture
Comparable T cell expansion and function between cytokine sources were demonstrated. Generated CAR-T cells showed robust cytotoxicity and lower exhaustion markers.
-
Enabling The Rapid, Reproducible Manufacturing Of TranspoCART Cells
Learn how an innovative technology streamlines Transpocart cell production, making rapid and consistent manufacturing a reality for cell therapies.
-
Unlocking Recruitment Potential In Trial-Naïve Sites
Site Professional Support enabled this late-phase rheumatoid arthritis study to conduct complex patient visits despite its use of sites that lacked research experience and resources.
-
The Need For Adaptive Distribution Partners For Cell And Gene Therapies
Optimize your commercial strategy by exploring how adaptive distribution models navigate reimbursement challenges and improve patient access. Partner early to align workflows and ensure operational success.
NEWSLETTER ARCHIVE
- 10.02.26 -- Building Sustainable Biopharma Supply Chains Starts With Procurement
- 10.01.26 -- New Podcast Episodes: 2026 Regulatory Updates, Funding A Virtual Biotech, Structuring CGT Deals
- 10.01.26 -- Building An End-To-End Strategy For CGT Manufacturing
- 10.01.26 -- Why CDMO Capacity Investments Signal A New Era In Cell & Gene
- 09.30.26 -- Fill/Finish Robotics Are Reshaping Aseptic Manufacturing
- 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?
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
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