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Gates Institute News and Stories

Bioengineering

Cell and Gene Therapy    Biotechnology    Bioengineering

Navigating Operational Complexities in Phase I GMP Cell Therapy Manufacturing: A Compliance Perspective

In the rapidly evolving field of cell therapy, the transition from research to clinical application is filled with challenges, particularly within Good Manufacturing Practice (GMP) production during first-in-human, early-phase clinical trials. These trials set the groundwork for both safety (primarily) and efficacy (secondarily) as therapies advance toward commercialization. Understanding the operational intricacies involved in manufacturing cell therapy products for these trials is crucial for stakeholders, including sponsors, innovators, investors, and regulatory compliance professionals.


Author Nidhi Kotecha | Publish Date June 11, 2024
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Gates Institute In the News

The Denver Post

CU studying use of patients’ own reprogrammed cells to attack cancer as alternative to more chemo

news outletThe Denver Post
Publish DateMarch 14, 2024

A study at University of Colorado’s Gates Institute on the Anschutz Medical Campus is looking at CAR-T in adult patients with acute lymphocytic leukemia, a cancer of the blood and bone marrow, whose first round of chemotherapy either failed or gave a disappointing response that suggests it won’t work for long, executive director Dr. Terry Fry said. (The institute is named for rubber manufacturer Charles C. Gates.)

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UC Davis News

UC Davis Graduating Student Poised to Help Those With Rare Condition

news outletUC Davis News
Publish DateDecember 12, 2023

Encouraged by his care team at the Colorado hospital to apply for an internship at the Gates Institute research lab, Mann spent this summer surrounded by researchers helping develop novel therapeutics for Ehlers-Danlos Syndrome (EDS). He worked on an experiment that used cells from EDS patients to grow skin samples for study. The lab is investigating the use of exosomes — secreted by most cells and present in tissues and body fluids — as a vehicle for therapeutic intervention.

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Colorado Bioscience Association

Building a Life Sciences Pipeline: Cell and Gene Therapy Momentum

news outletColorado Bioscience Association
Publish DateMarch 06, 2023

When you talk to Terry Fry, M.D., about why the Gates Institute is one of the best locations in the country to work in cellular and gene therapy, he has a lot of insight. As the executive director of the Gates Institute, a pediatric oncologist, and a pioneer in the development of chimeric antigen receptor (CAR)-T cell therapies, Dr. Fry has an intimate understanding of what it takes to get a drug from initial research phases to commercial manufacturing.

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Genetic Engineering & Biotechnology News

University Creates Innovative Model for Running a GMP Manufacturing Facility

news outletGenetic Engineering & Biotechnology News
Publish DateFebruary 08, 2023

The University of Colorado has adopted an innovative model for running an academic GMP manufacturing facility without extensive endowment funding. The Charles Gates Biomanufacturing Facility is one of only a few GMP facilities able to manufacture cell- and protein-based therapies for both academic researchers and industry.

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