Regulators expect cell therapy manufacturers to prove they control for visible particles, but guidance remains notably quiet on the matter. Companies must get creative or risk clinical holds.
- 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
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Virus Retention Performance Under Diverse Processing Conditions]( "Virus Retention Performance Under Diverse Processing Conditions")
Virus Retention Performance Under Diverse Processing ConditionsVirus filtration is robust across a wide range of process parameters, including high protein concentration and flow decay. Discover how retention relies on size exclusion to simplify risk assessment.
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![Hollow Fiber AAV App Note]( "Why Membrane Matters In AAV Filtration")
Why Membrane Matters In AAV FiltrationGene therapy is revolutionizing medicine to offer one-time treatments. Find out how AAV vectors are leading the way to optimize production and make these life-changing therapies accessible.
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![GettyImages-1987435635 research, planning]( "Rescuing A Global Program For NDA Success")
Rescuing A Global Program For NDA SuccessExplore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.
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![GettyImages-1388281743 pharmacy]( "Addressing A Critical Drug Shortage")
Addressing A Critical Drug ShortageA critical drug shortage demanded regulatory action, importation support, and patient program readiness. See how integrated QA, 3PL, and PSP capabilities delivered operational readiness in three months.
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![GettyImages-1323467662 data, meeting, strategy]( "Don't Let Distribution Derail Your CGT Launch")
Don't Let Distribution Derail Your CGT LaunchOvercoming distribution challenges is critical for the success of cell and gene therapies. Learn how to build a flexible, robust strategy to optimize patient access.
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![GettyImages-2176475661 tabet press, pharma manufacturing]( "Quality By Design In The Pharmaceutical Industry")
Quality By Design In The Pharmaceutical IndustryReal-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.
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![GettyImages-1493118778 blood, cell therapy]( "Challenges, Methods, And Solutions For Obtaining Optimal Starting Material")
Challenges, Methods, And Solutions For Obtaining Optimal Starting MaterialFor innovative treatments like CAR-T and stem cell transplants, optimal starting material is key. Understanding collection challenges and new solutions helps ensure the best foundation for these therapies.
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![Cytiva]( "Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process")
Customer Story: Emergent BioSolutions Enhances Aseptic Filling ProcessUpgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.
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![GettyImages-2190227480-laboratory-scientists-computer-equipment-research]( "Automation Of 3D Intestinal Organoids Culture")
Automation Of 3D Intestinal Organoids CultureGain insight into how 3D organoids promise better disease modeling and drug screening and how challenges like assay complexity, reproducibility, and scalability hinder their widespread adoption in drug discovery.
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![Viral Safety In Monoclonal Antibody Manufacturing-Getty-184714532]( "Study Viral Infection In Resting Humans CD4+ T Cells With Synthetic sgRNAs")
Study Viral Infection In Resting Humans CD4+ T Cells With Synthetic sgRNAsDiscover how Synthego's proprietary synthetic sgRNA, combined with Lonza’s 4D-Nucleofector®, enabled highly efficient gene editing in resting human CD4+ T cells.
NEWSLETTER ARCHIVE
- 09.08.26 -- Cell Therapy Advances And Biotech Leadership With Nkarta's Paul Hastings
- 09.08.26 -- Choose New Analytical Technologies At The Right Stage Of Development
- 09.04.26 -- New Podcast Episodes: Fixing AAV Recovery, Cell Therapy Advances, Reimagining Solid Tumor Immunotherapy
- 09.04.26 -- The Blueprint For Viral Vector Manufacturing Success
- 09.04.26 -- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- 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.
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