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The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

Advarra

Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their use is becoming increasingly common in clinical trials. The post The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering appeared first on Advarra.

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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

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Researchers Halt Trial of Promising Sickle Cell Treatment

NY Times

Two patients in a gene therapy study developed cancer years after treatment. It is not clear whether the therapy was responsible.

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Spotlighting Lupus Awareness Month: CAR-T Technology Creates New Avenues for Treatment of a Devastating Disease

WCG Clinical

CAR-T Cells Target Harmful B Cells in Lupus CAR-T cell technology, which uses genetic engineering to direct white blood cells to attack specific molecular targets, was originally proposed for treatment of HIV infection and hematological malignancies. WCG has many ways to support cell and gene therapy clinical trials for lupus.

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How single-use technologies can improve antibodies production  

Drug Discovery World

This means we are able to hijack the cell machinery to be even more efficient than before to produce more of what we want (mAb) and less of what we don’t want (impurities) through the different genetic editing tools for cell engineering. as well as viral reduction and other product-related impurities.

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IBC vs. IRB: What’s the Difference?

Advarra

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What Does an IBC Review? How is IBC Membership Composed?

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Leading innovators in transcription factors for AAV for the pharmaceutical industry

Pharmaceutical Technology

Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. There are two main genes in the AAV genome, rep and cap, which encode nine different proteins.

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