Safety and efficacy are key considerations in engineered cell therapies. Any technology that modifies the genome has the potential to cause genotoxicity. The accuracy of editing and the potential occurrence of unintended rearrangements should be assessed to understand the associated risks, such as cassette insertion in the vicinity of an oncogene or a tumor suppressor.
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questexweb
Enabling formulations becomes more and more necessary to obtain adequate exposure of APIs during (pre)-clinical research. Currently, most registered formulations to improve bioavailability are based on lipidic systems, which make use of intrinsic digestion processes within the GI tract, facilitating the absorption of APIs. Aside from a general absorption mechanism, lipidic systems can also promote lymphatic transport of poorly soluble drugs, such as hormones. In addition, many different indications, such as HIV therapy, oncology, immunosuppressant and even arising therapies related to medicinal cannabis (e.g. CBD) can benefit from lipid formulations. These formulations create multiple possibilities for oral administration because they can be manufactured as solutions, suspensions, emulsions, and self-(micro)emulsifying systems.
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genengnews.com
The voyage of a cell or gene therapy from initial hypothesis to commercial delivery is complex and challenging. It requires a broad spectrum of scientific expertise, innovative technologies, and optimized processes to ensure these advanced therapeutics make it to market. In this GEN webinar, our panelists—two industry leaders—will discuss what it takes to develop a cell or gene therapy from concept to commercialization, alongside a conversation about innovations that are likely to shape the future of advanced therapy discovery and biomanufacturing.
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statnews
Clinical trial data can be remarkably (and unnecessarily) difficult to read. Companies spin, short-sellers hawk, and everyone else is left swimming through the muck. But there is an art to reading scientific results — and you can learn it.
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