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It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. Microbial bioassay – measures the potency of a biological active substance (e.g.,
As the field strives to strike a delicate balance between safety and efficacy, in the context of increased regulatory scrutiny and safety challenges, attending the 4 th Annual Gene Therapy Analytical Development as an analytical scientist has never been so important.
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