CoRegen’s investigational autologous cell therapy, CRG-150, is designed to disrupt tumor-driven immune suppression by knocking out SRC-3 in Tregs, potentially exposing solid tumors to the patient’s own immune response without lymphodepletion.
- What Goes Into Restarting A Shelved Orphan Drug Candidate?
- A Much-Improved Approach For Understanding And Managing Safety Risks
- Immune Reset In Rheumatology: Moving Beyond Disease Suppression Toward Durable Remission
- CSV Assumes The AI System Sits Still — It Doesn't.
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
- Combination Cell Therapy's Clinical Success Hinges On Manufacturability
- Are Biopharma Companies Outsourcing Their Ability To Think?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2190227882-male-scientist-lab]( "Native RPLC For ADCs: How Column Hydrophobicity Shapes DAR Separation")
Native RPLC For ADCs: How Column Hydrophobicity Shapes DAR SeparationADC characterization does not have to be overwhelmed by complex intact MS profiles. Smart column selection can improve separation, clarify critical quality attributes, and make ADC analysis easier.
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![GettyImages-1026593952 tablet, data]( "Difco TC Yeastolate Ultra-Filtered (TCY UF) In Scale-Up Optimization")
Difco TC Yeastolate Ultra-Filtered (TCY UF) In Scale-Up OptimizationExplore how Difco™ TC Yeastolate ultra-filtered (TCY UF) enabled over 100% improvement in titer for CHO cell culture through feed optimization and bioreactor scalability in a real-world application.
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![GettyImages-2217414221 manufacturing, tablet]( "Essential Strategies For Effective Viral Clearance Studies In Biologics Manufacturing")
Essential Strategies For Effective Viral Clearance Studies In Biologics ManufacturingStrengthen your viral safety strategy by applying science- and risk-based approaches to viral clearance planning, ensuring robust data, regulatory compliance, and patient protection.
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![GettyImages-1462147534 manufacturing]( "5 Steps To Design A Microbiological Performance Qualification For Facilities")
5 Steps To Design A Microbiological Performance Qualification For FacilitiesExplore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
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![Corning - hyperstack]( "Expansion Of Human Bone Marrow-Derived MSCs")
Expansion Of Human Bone Marrow-Derived MSCsAchieving over 870 million viable, quality mesenchymal stem/stromal cells is possible. This efficient cell culture method scales bone marrow-derived MSCs for clinical needs.
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![GettyImages-1493586956-assay-bottles-laboratory-scientist]( "Fast And Scalable Fc Quantitation In Supernatants")
Fast And Scalable Fc Quantitation In SupernatantsIn biopharmaceutical development, the Fc PAIA Titer assay offers a fast, cost-effective, and automatable solution for high-throughput Fc quantification to enhance efficiency, support research, and accelerate production advancements.
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![GettyImages-158649166 assay]( "Commercial Success Starts With A Fit-For-Purpose Flow Cytometer")
Commercial Success Starts With A Fit-For-Purpose Flow CytometerDiscover how standardizing reagents and automating flow cytometry workflows can improve reproducibility, reduce troubleshooting, and accelerate progress in cell-based therapies.
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![GettyImages-1218745370 cleanroom, disinfecting, lab]( "Contamination In The Shadows: Risks Lurking From Environmental Issues")
Contamination In The Shadows: Risks Lurking From Environmental IssuesDiscover how science-based bio-decontamination strategies effectively eliminate invisible pathogens and rapidly restore facilities to operational safety following major infrastructure disruptions.
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![doctor holding vial of medicine-GettyImages-1287223643]( "Effective Strategies To Minimize Product Loss During Fill Finish")
Effective Strategies To Minimize Product Loss During Fill FinishEvery drop of high-value biologic lost in fill finish is money left on the table. Learn practical strategies to protect your yield.
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![GettyImages-2187764040-cell-culture-testing-manufacturing-in-lab]( "Smart Scaling For Cell And Gene Therapies")
Smart Scaling For Cell And Gene TherapiesTo meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.
NEWSLETTER ARCHIVE
- 08.20.26 -- Are Biopharma Companies Outsourcing Their Ability To Think?
- 08.19.26 -- Building A More Scalable Gene Therapy Program
- 08.19.26 -- Scaling Human-Relevant Science For Biologics Development
- 08.19.26 -- Redefining Autoimmune Treatment Via Antigen-Specific Immune Tolerance
- 08.18.26 -- The Missing Link Between AI Pilots And Production Success
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
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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