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Some of the variables include the chemical composition of the LNP, the manufacturing process and of course the RNA itself, whose design and production must elicit the intended therapeutic outcome.” They can’t be derived from animal products, but they are often synthesised in low purity – 60%-70% pure. weight abundance.
Bioassay – A Prerequisite for the Cell and Gene Therapy Development. Over the past few years, investigational new drug (IND) filings for cell and gene therapy product have significantly increased. Bioassays are biochemical procedures that are used to evaluate the potency, purity and efficacy of a drug substance.
As part of the collaboration, Toregem will use WuXi Biologics’ integrated CMC services in cell culture development, cell line development, bioassay development, biologics GMP manufacturing, cell banking and testing services, as well as other related services. TRG035’s Phase I clinical study is scheduled to begin in early 2024.
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