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.
New product introduction
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A standard process map providing industry with a set of simple tools containing a structured approach for materials introduction across the supply chain. This paper summarizes a stepwise process that can be used as a guideline for introducing a material to support new drug substance manufacture and can be used in conjunction with detailed, company-specific NPI procedures. In addition it is relevant best practice for cell and gene therapy manufacturers.