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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Engineering Challenges In Designing Pharmaceutical Isolators
Designing pharmaceutical barrier systems requires balancing strict cleanliness with practical engineering. Explore key factors for optimizing airflow and ergonomics.
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A Paradigm Shift From Glass Benchtop Bioreactors
Learn how a bench-scale single-use bioreactor offers process development advantages over traditional glass systems, including higher efficiency, increased productivity, and enhanced sustainability.
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Targeted Indication Selection Using Adaptive Design
What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?
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Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals
Explore how digital solutions help streamline mRNA manufacturing by reducing costs, improving efficiency, and supporting sustainability by creating paperless processes for emerging therapeutics.
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Form Fill And Seal Label Applicator For Drug Packaging
Discover a solution that ensures particularly efficient and reliable vertical and horizontal form fill and seal machine labeling.
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CAR Expression Detection Using Fluorescent Labeled Proteins, Flow Cytometry
Learn how site-specific fluorescent labeling addresses key challenges in flow cytometry-based evaluations by enhancing assay sensitivity, reducing variability, and ensuring reliable results.
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Novel Cardiotoxicity Evaluation Method Using iPS-Derived Cardiomyocytes
Discover how real-time monitoring of glucose and lactate in iPS-derived cardiomyocytes reveals subtle drug-induced metabolic shifts that traditional screening methods often fail to detect.
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Metabolic Phenotype Preservation And Suitability Of hMSCs Cultivated In Stirred Tank Bioreactors
Learn how researchers demonstrated scalable hADSC expansion in stirred-tank bioreactors using microcarriers, achieving metabolic stability and consistent growth for cell therapy applications.
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Assessing The Success Of CRISPR Gene Therapies Using ddPCR Technology
Achieve high-fidelity results in gene therapy research. Discover how absolute quantification overcomes traditional limitations to provide the precision needed for validating CRISPR edits.
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Scale-Up Approaches For Culturing Adherent Cells
For successful scale-up, see how optimizing process parameters such as attachment methods, gassing, and agitation can help reduce cell environmental stress, ultimately improving productivity.
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.
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