This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CDMO Selection: Start With The Relationship, Not The RFP
- Why FAT Should Confirm Alignment, Not Reveal Its Absence
- Managing Supply Disruptions In ATIMP Clinical Trials
- Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge
- What Reliance, Annex 1, And AI Mean For The Future Of GMP
- Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss
- Applying Contamination Control By Design: A Practical Guide For CDMOs
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2189362114-recombinant-protein-structure]( "Yeast Extracts: Improving Expression")
Yeast Extracts: Improving ExpressionYeast extract improves E. coli protein production by over 50%, boosts desired protein attributes 4X, and offers a secure animal-free nutrient source.
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![GettyImages- 1346675538 research]( "Guide To Seeding, Expanding, And Harvesting Stem Cells")
Guide To Seeding, Expanding, And Harvesting Stem CellsInvestigate important considerations for working with three different stem cell types: mesenchymal stem/stromal cells, induced pluripotent stem cells, and neural stem cells.
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![GettyImages-1330728771-microscope-lab]( "Performance Of HEKima™ Adherent HEK Cell Medium")
Performance Of HEKima™ Adherent HEK Cell MediumExplore the performance of a serum-free medium designed for HEK-293 cells, comparing its efficacy to traditional media for protein expression and cell proliferation.
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![GettyImages-947704926-wells-plate-assay-red-liquid]( "High-Throughput IgG Quantification Assay For Cell Line Development")
High-Throughput IgG Quantification Assay For Cell Line DevelopmentMonoclonal antibodies are revolutionizing treatment for various diseases, which include cancer and autoimmune disorders. Discover how improving production methods can reduce costs and enhance accessibility.
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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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![Corning - closed system]( "How To Take Your Process To A Closed System")
How To Take Your Process To A Closed SystemUnderstand the critical considerations for implementing closed systems in bioproduction, from vessel selection to workflow customization for optimal efficiency and safety.
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![GettyImages-2165310987-chromosome-nucleotide-gene]( "Automating Mass Spectrometry Analysis To Accelerate Oligonucleotide Drug Development")
Automating Mass Spectrometry Analysis To Accelerate Oligonucleotide Drug DevelopmentOligonucleotide therapeutics demand precise and efficient analytical workflows. Explore how automated data processing offers a faster path to understanding metabolites and advancing development.
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![GettyImages-1327318287-spheres-cancer-cells-microscopic]( "Cell Culture Automation Of The 3D Cancer Spheroid Assay")
Cell Culture Automation Of The 3D Cancer Spheroid AssayDiscover how automated 3D cell culture methods enhance efficiency and consistency in high-throughput drug screening to accelerate the discovery of new anti-cancer therapies.
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![Emulate Liver Chip]( "A Human-Relevant Model Of The Liver Sinusoid")
A Human-Relevant Model Of The Liver SinusoidThis organ-on-a-chip model minimizes drug absorption while maintaining the essential architecture. Explore the specifications of this product engineered to model the human liver.
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![240327_BMJ1L8A6473]( "Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges")
Leveraging Single-Use Solutions To Solve Working Cell Bank ChallengesDiscover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.
NEWSLETTER ARCHIVE
- 06.05.26 -- New Podcast Episodes: Validation Challenges, Rare Disease Drug Commercialization, Redefining CAR-T Timing, and More
- 06.05.26 -- Understanding The Real Risk When Using Research-Grade Material For In-Human Testing
- 06.04.26 -- Next-Gen Precision Control For Cell Therapy Workflows
- 06.04.26 -- Distributed Manufacturing For CGT: Rent, Lease, Or Buy In An Era Of Overcapacity?
- 06.03.26 -- From Gene to GMP: Solving Advanced Therapy's Toughest Manufacturing Challenges
- 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
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
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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