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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![Thermo - bioreactors]( "The Importance Of Quality In Raw Material Selection")
The Importance Of Quality In Raw Material SelectionLearn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
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![GettyImages-1746637448-laboratory-tablet-analysis-vial]( "Liquid Biopsy-Based Detection Of PIK3CA Mutations From cfDNA")
Liquid Biopsy-Based Detection Of PIK3CA Mutations From cfDNADiscover how ultra-sensitive digital PCR workflows use an innovative system to enable precise detection of rare PIK3CA mutations in cfDNA and advance personalized cancer treatment.
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![GettyImages-1429367489 iPSC]( "CRISPR Reagents Enable High Efficiencies Of Editing And HDR In iPSCs")
CRISPR Reagents Enable High Efficiencies Of Editing And HDR In iPSCsAchieving consistent Homology Directed Repair (HDR) in iPSCs requires optimized CRISPR design and workflows. See how advanced reagents and targeted enhancement strategies improve insertion efficiency.
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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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![SUS - homogenization]( "Study: Ensuring Homogeneity In Biopharmaceutical Aliquotation")
Study: Ensuring Homogeneity In Biopharmaceutical AliquotationTired of manual manipulation risks in biopharmaceuticals? Discover how automated homogenization ensures consistent cell counts and concentration levels, improving patient safety and process reproducibility.
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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-2184219690-chimeric-antibody-3d-render]( "How To Design And Evaluate Bispecific Antibodies (BsAbs)?")
How To Design And Evaluate Bispecific Antibodies (BsAbs)?Bispecific antibodies combine two antigen-binding sites to enhance efficacy and safety. Their design requires structural strategy, MOA-based evaluation, and rigorous screening for optimal therapeutic performance.
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![GettyImages-2164415438-petri-dish-bacteria-scientist-gloved-hands]( "Monitoring Microbial Contamination Of Mammalian Cell Cultures")
Monitoring Microbial Contamination Of Mammalian Cell CulturesMammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.
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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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![biologics-bioassay-GettyImages-1138314395]( "Case Study: The Right Ratio – Building An End-To-End DAR Strategy For ADC Success")
Case Study: The Right Ratio – Building An End-To-End DAR Strategy For ADC SuccessWhen developing antibody-drug conjugates (ADCs), a robust drug-to-antibody ration (DAR) strategy isn’t just nice to have — it's mission-critical.
NEWSLETTER ARCHIVE
- 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
- 08.18.26 -- Building Platform Strategies Instead Of One Off Vector Solutions
- 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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