NGS enables broad detection of known and novel viruses in a single assay. Its high sensitivity, specificity, and scalability can meet GMP throughput levels.
- The Promise Of MRD-Guided CAR-T Treatment
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- A QMS That Anticipates Cell And Gene Therapy Quality Challenges
- Using Digital Platforms To Find Your CDMO
- July 2026 — CDMO Opportunities And Threats Report
- ADC CDMO Selection For Small Biotech
- Implementing AI Solutions In GMP While Managing Risk
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Recruiting & Retaining More Patients Per Site:
Through Home Trial Support (HTS) services, MRN is able to enhance the accessibility of clinical trials while reducing the emotional toll on their patients suffering from loss of mobility.
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Scaling Success: A Blueprint For Flexible Biometrics Partnerships
Learn how a micro-FSP model and integrated biometrics team can scale from specialized support to a full-service solution, ensuring agility and consistency as clinical trial needs evolve.
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Transforming Development Through Mass Spectrometry Data Analysis
Mass spectrometry is vital for understanding PTMs in modern biologics. Explore key challenges and how streamlined analysis can reveal deeper, more sensitive insights into biotherapeutic structure.
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Advanced Aseptic Filling Assembly Helium Integrity Testing
Helium leak testing offers unmatched sensitivity for detecting micro-leaks in single-use fill-finish systems. Learn how tighter leak thresholds can strengthen aseptic processing and regulatory confidence.
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A Comprehensive Solution For Adventitious Agent Testing
Modern 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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Standardizing Cryopreservation For Cell Therapy Supply Chains
Explore how a standardized cryopreservation process is transforming leukapheresis handling by reducing risk and improving quality across the cell therapy supply chain.
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Production Of A Highly Concentrated Monoclonal Antibody
The production of a highly concentrated monoclonal antibody requires many process steps. Discover how to achieve a final mAb concentration above 200 g/L while maintaining critical quality attributes.
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Automating High-Throughput Screens Using Patient-Derived Organoids
Many oncology drugs fail in later development stages due to inadequate predictive models. Explore how 3D cell models, like patient-derived organoids, offer a promising solution in the drug development process.
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What Is Size Exclusion Chromatography (SEC)?
Aggregation can compromise mAb quality at many stages of development. Learn why size exclusion chromatography is a trusted approach for detecting aggregates and supporting confident characterization.
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Biopharma Supply, Reimagined: Regional, Resilient Manufacturing
Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
NEWSLETTER ARCHIVE
- 09.14.26 -- Your Collaborator: mAb Productivity And Robustness
- 09.14.26 -- How To Select The Right Manufacturing Model For Your Pipeline
- 09.12.26 -- Cell & Gene Newsletter - Best Of August
- 09.11.26 -- Why Autoimmune CAR T Needs A New Patient-Centered Playbook — With Dr. Panteli Theocharous
- 09.10.26 -- Is Your Fill/Finish Strategy Ready To Scale?
- 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
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
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