Unique RNA product aspects that could impact a transfer process

Sponsors of RNA products regularly utilize contract manufacturing and testing organizations (CMOs & CTOs) to manufacture & release their product. A critical first stage in this partnership is transferring activities to the contract organization and will be first discussed at a New Product Introduction (NPI) meeting, co-hosted by the product sponsor and CMO/CTO. While the general process of transfer is well established for general biological drugs and improving for cell and gene therapy products, the unique challenges that may result from the novel nature of RNA products may be overlooked that could result in challenges and delays to this transfer.

This BioPhorum member only publication is intended to provide a guide of unique RNA product aspects that should be discussed during the NPI kick off meeting for an RNA product to enhance the probability of success of a product transfer between sponsor and contract organizations.

This document is reserved for the use of BioPhorum members only.

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