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But the mRNA technology is not yet mature and there are no standardised manufacturing protocols yet. 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.” weight abundance.
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.
The inaugural Gene Therapy Comparability Summit is the only industry dedicated meeting to ensuring your manufacturing processes are effective and comparable at every stage of development, supporting a seamless transition to the larger scales required for commercialization. The post Gene Therapy Comparability appeared first on.
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The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Optimising development and scale-up. Bioburden and microbial testing.
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