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How Potential Changes to the NIH Guidelines Could Impact IBC Review

WCG Clinical

Although the NIH Guidelines were originally written with non-clinical laboratory research in mind, they also apply to human gene transfer (HGT) research, wherein rsNA or rsNA-containing products are administered to research participants. Since then, however, certain genetic engineering technologies (e.g.,

Genome 52
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Using bispecific antibodies to advance cancer immunotherapy

pharmaphorum

Though advances in genetic engineering have greatly supported high-producing cell lines, the successful development of bsAbs at scale relies on the genetic stability of such lines. Therapeutic bsAbs also require a highly selective and easy-to-scale system to obtain a suitable purity for the final product.