Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
- 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
- New USP Guidelines, Standards Address Lentivirus Characterization
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1219370954-scientist-in-lab-with-cell-culture]( "Reduce Complexity, Not Quality In CAR T Cell Manufacturing")
Reduce Complexity, Not Quality In CAR T Cell ManufacturingFragmented CAR T cell manufacturing workflows drive up costs and extend timelines. This case study quantifies what consolidating manufacturing and QC through automation actually delivers.
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![gettyimages_1331137712_regulatory]( "Boosting CMC Regulatory Efficiency In Gene Therapy")
Boosting CMC Regulatory Efficiency In Gene TherapyEnsure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.
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![GettyImages-547131922 research, regulatory, lab]( "Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ")
Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQThe 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.
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![Computer Science Research Laboratory with Robotic Arm Model-GettyImages-968289652]( "ICH E6(R3) In Effect: Transforming Quality Management For Cell And Gene Therapy Trials")
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![Modern Medical Research Laboratory GettyImages-1354171846]( "Electroporation Enables The Efficient, Scalable Packaging Of CRISPR-Cas9 RNPs In Virus-Like Particles")
Electroporation Enables The Efficient, Scalable Packaging Of CRISPR-Cas9 RNPs In Virus-Like ParticlesDiscover how electroporation technology enables efficient, scalable production of CRISPR-Cas9 VLPs with high editing activity in both adherent and suspension HEK293 cells.
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![GettyImages-2187764040-cell-culture-testing-manufacturing-in-lab]( "A Comprehensive Solution For Adventitious Agent Testing")
A Comprehensive Solution For Adventitious Agent TestingModern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.
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![GettyImages-2174865907 workflow, lab, cell therapy]( "Successful Cell-Based ADA Collaboration In mRNA Gene Replacement Therapy")
Successful Cell-Based ADA Collaboration In mRNA Gene Replacement TherapyA biotech firm developed a rapid, sensitive, cell-based ADA assay through collaborative innovation, reducing variability and turnaround time while improving performance for mRNA gene therapy.
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![GettyImages-520218913-fluorescent-light-microscope-glove-well-plate]( "Sensitive RNA Fluorescent Quantitation With An RNA Assay Kit")
Sensitive RNA Fluorescent Quantitation With An RNA Assay KitAccurate nucleic acid quantification is vital for applications like PCR and NGS. Discover an RNA Assay Kit that offers precise RNA measurement to enhance reliability and performance in downstream assays.
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![GettyImages-843764526-blood-sample-tube-aav-testing]( "A Novel Approach To Improving AAV Titers")
A Novel Approach To Improving AAV TitersAs demand for AAV-based therapies rises, optimizing production processes is essential. By utilizing existing technologies, tailored platforms, and optimized formulations, titers and productivity can be enhanced.
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![Thermo - DynaSpin]( "Finding An Optimal Harvest Solution By Considering Both Cost And Sustainability")
Finding An Optimal Harvest Solution By Considering Both Cost And SustainabilityOptimize your bioprocessing harvest with single-use centrifugation. Reduce costs, waste, and space needs compared to traditional depth filtration methods.
NEWSLETTER ARCHIVE
- 09.30.26 -- Fill/Finish Robotics Are Reshaping Aseptic Manufacturing
- 09.30.26 -- Modularity And Flexibility For Single-Use Biopharma Assemblies
- 09.30.26 -- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- 09.29.26 -- Capsid Selection And Tissue Targeting Begin Long Before Manufacturing
- 09.29.26 -- In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
- 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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