The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
- 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
- What FDA Inspectors Want From Your OOS File
- You Can't CAPA What You Can't Classify
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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High-Performing Ionizable Lipids For Controlled Nucleic Acid Delivery
Ionizable lipids are central to effective mRNA delivery, influencing potency, biodistribution, and toxicity. See why advancing delivery beyond the liver will require stronger structure-function insights.
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The Future Of Clinical Trials: 7 Trends Redefining FSP Models By 2030
Learn why factors like decentralized trials and tighter global rules are pushing sponsors to favor fewer, deeply integrated, tech-driven partners over traditional staffing models for clinical outsourcing.
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Selecting A Central Lab Network For Radiopharmaceutical Readiness
A wave of late-stage radiopharmaceutical trials is straining lab infrastructure concentrated in a handful of academic centers, limiting site diversity, expertise, and trial capacity nationwide.
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The Answer To Advance Your Allogeneic CAR-T Cell Clinical Trial
Dozens of assays, a shifting sample analysis plan, and a network of specialty labs: see how coordinated oversight kept an allogeneic CAR-T trial on track.
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Assessing Viability And Real-Time Apoptosis/Necrosis
Malignant gliomas are aggressive brain tumors that resist standard treatments. Discover why researchers focus on real-time cell death dynamics to develop targeted therapies and promising strategies.
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Perfusion Cell Line Development For Intensified Processes
The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.
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CQA Assessment Of LNP-Encapsulated IVT mRNA
Learn more about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.
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Advancing Dose Escalation Strategies With Bayesian Modeling
A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.
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Decoding AAV: Navigating Critical Quality Attributes And Their Analytics
For groundbreaking genetic treatments, stringent quality control is non-negotiable. This exploration delves into defining essential attributes and the analytical tools that safeguard their consistent production.
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Cell Retention Technology And Specialized Cell Culture Media
Explore how perfusion technology is transforming upstream bioprocessing by boosting productivity, reducing costs, and enabling process intensification while overcoming cell retention challenges.
NEWSLETTER ARCHIVE
- 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
- 09.30.26 -- Modularity And Flexibility For Single-Use Biopharma Assemblies
- 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
- In Vivo CAR T Needs More Than Better Cell Engineering
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