This BioPhorum member only questionnaire presents a tool for sponsors to ascertain the suitability of the contract organization services and for the contract organizations to understand the scope, requirements, and timelines of the RNA transfer project.Â
New product introduction
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Unique RNA product aspects that could impact a transfer process
Oct 2022 | Cell & Gene Therapy, Deliverables Report, Publication, RNA as a Therapeutics and a Gene-Editing Tool
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.
Guidelines for materials introduction supporting drug substance delivery
Nov 2021 | Drug Substance, Forecast and Demand Planning, POI - Supply Partner, Publication, Supply Partner
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.