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
-
Effective Strategies To Minimize Product Loss During Fill Finish
Every drop of high-value biologic lost in fill finish is money left on the table. Learn practical strategies to protect your yield.
-
Streamline Your AAV Process With A Production Platform
AAVs are reshaping gene therapy, but scaling production introduces complexity. Learn how upstream process optimization can improve yield, consistency, and speed to meet growing demands.
-
Delivering Specialist Neurology Support
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
-
Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility
Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.
-
5 Steps To Design A Microbiological Performance Qualification For Facilities
Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
-
Maximizing MSC Yield And Quality: A Comparative Media Study
Maximize mesenchymal stem cell (MSC) expansion with a simplified culture process. New data demonstrates a high-performance, xeno-free media that eliminates the need for coatings or media exchanges.
-
Shielded BSCs: Regulatory Requirement Or Risk-Based Engineering Solution?
Master the balance between USP <825> aseptic standards and radiation safety. Learn how integrated engineering solutions ensure regulatory compliance while protecting both patients and personnel.
-
A Bright Future For Eye Care: The Advanced Therapy Revolution Is Here
Groundbreaking cell and gene therapies are revolutionizing eye care. Discover how advanced treatments target root causes, offering unprecedented hope for conditions previously deemed untreatable.
-
hiPSC Aggregate Expansion In Stirred-Tank Bioreactors
Learn about a bioreactor-based Human Induced Pluripotent Stem Cell (hiPSC) expansion workflow with the potential to improve cell therapy applications.
-
Partner Case Study: Accelerating Gene Editing Manufacturing
Beam Therapeutics partnered with ElevateBio to manufacture BEAM-101, a novel base editing therapy for sickle cell disease, advancing rapid, high-quality production towards clinical trials.
NEWSLETTER ARCHIVE
- 08.21.26 -- Smarter Workflows For Cell & Gene Production
- 08.21.26 -- Rewriting The Playbook For Stargardt Disease With Shannon Boye, Ph.D.
- 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
- 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.
More Content Collections