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Safe Sharps Handling When Dispensing Investigational Products

Advarra

Injuries from sharps in a research or clinical setting are a serious problem for employees, as the CDC estimates almost 400,000 needlesticks and other sharps-related injuries occur to healthcare personnel each year. All potentially infectious sharps must be disposed of in a biohazard sharps container immediately after use without recapping.

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Clean Bench vs Biosafety Cabinet: What’s the Difference?

Advarra

This article explores how these tools work and why biosafety cabinets are preferred in research involving cell and gene therapies. Why Does the IBC Prefer Researchers use a Biosafety Cabinet vs a Clean Bench? In the case of IBC review, we’re preventing exposure to biologics such as engineered genetic materials and/or infectious agents.

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Thinking About the Box: Considerations for Transport of Investigational Products

Advarra

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. And don’t forget to affix a biohazard sticker to the exterior for quick and clear identification.

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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. IRBs are tasked with protecting research subject’s rights and welfare. What Does an IBC Review?