Transfer of contract

Mid-stage development typically includes screening experiments for design of experiments (DoE) studies, DoE itself, and early process design and definition. If possible, this information is used to manufacture a demonstration batch or batches to give an indication of process capability and identify additional R&D and optimization to be made prior to manufacture of registration and validation batches in late stage development. The rendering of DoE data into process knowledge that informs demonstration batch manufacture is another example of expansion of the process knowledge base during ongoing work, rather than between discrete stages of development.

Transfer of contract

transfer of contract

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