Here's why scaling MSC therapies requires maintaining product consistency, potency, and comparability as manufacturing evolves.
- 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
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Bringing Next-Gen Sequencing To GMP Scale
- Risk Managing Through The Void Of ATMP Visible Particle Guidance
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
How To Effectively Manage Local Affiliate Pharmacovigilance Outsourcing
Managing PV across dozens of markets strains even experienced safety teams. Learn about a framework that helps you maintain compliance, reduce risk, and scale confidently into new markets.
-
Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products
Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
-
Building A Smarter Potency Strategy For Bispecific Antibodies
A biotech company needed a regulatory-ready potency strategy for a bispecific antibody. This organization combined orthogonal analytics with functional assays.
-
Automated Enrichment Of Human CD34+ Cells
Discover an automated strategy for enriching CD34+ cells, combining streamlined processing, strong purity and viability metrics, and reduced hands-on effort to support stem cell engineering.
-
Consistent Improvement In CHO-K1 GS Performance With Efficient-Pro Feed 3 And Efficient-Pro Feed Enhancer
Optimize your CHO-K1 GS cell line with advanced chemically defined, animal origin-free feeds. Achieve higher titers and reliable product quality.
-
Small Volume ATMP Cryo-Freezing Strategies
Discover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.
-
Organ-On-A-Chip Technology Unlocks Patient-Derived Precision Medicine
Personalized medicine struggles with models that fail to reflect real human biology. Organ-on-a-Chip systems recreate tissue complexity, helping predict patient-specific treatment responses.
-
Flexible Multiplex Solution For VCN Determination In Gamma-Retrovirus–Transduced CAR-T Cells Using QIAcuity® dPCR
See how a multiplex digital PCR approach enables accurate, reproducible VCN determination in gamma‑retrovirus–transduced CAR‑T cells, supporting streamlined workflows and confident decision‑making.
-
IVT mRNA Encapsulation Efficiency Assessment
In vitro transcribed mRNA revolutionizes biotherapeutics, which necessitates thorough quality assessments. See how an analyzer system enhances encapsulation efficiency and CQAs in IVT mRNA workflows.
-
Nucleic Acid-LNP Ultrafiltration And Diafiltration
Downstream filtration can make or break LNPs at scale. See how membrane format, loading, and shear affect recovery and stability — and how alternative TFF lowers scale‑up risk.
NEWSLETTER ARCHIVE
- 09.25.26 -- The Promise Of MRD-Guided CAR-T Treatment
- 09.24.26 -- OPCU Special CPHI Session: Trends Shaping Advanced Therapies
- 09.24.26 -- The Unspoken Truth About Cell Therapy Product Understanding
- 09.23.26 -- Europe's ATMP Opportunity Still Requires Local Navigation
- 09.22.26 -- How Regeneron Navigates Early Cell And Gene Therapy Quality Risks
- 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.
More Content Collections