In the context of testing a new biologic automated manufacturing process for commercial use, typically, validation comes first before equivalence testing.
Validation is the process of establishing documented evidence that the manufacturing process consistently produces a product that meets predetermined specifications and quality attributes. Once the automated process is validated and confirmed to meet the required standards, equivalence testing might be conducted.
Equivalence testing aims to demonstrate that any modifications or changes made to the manufacturing process (such as automation) do not significantly alter the product's critical attributes or performance compared to the previously established process.
So, validation ensures the new process meets the required standards, and then equivalence testing verifies that the changes made do not adversely** affect the product's quality or efficacy.
Without looking back at postings on the new regs, equivalency testing can be shortened. I suspect clues to how this will be done can
be located in Dr. Bosch’s last ASCO presentation.
I believe it will/does involve proteomics testing.
Obviously, this could shorten years to months. Particularly due to the robust safety of this technology.
(**And remember, there is greater leeway for validation and equivalency, where the stated goals are surpassed.)
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