CGT considerations when assigning responsibilities during a product transfer between a sponsor and a contract development manufacturing organization

A key difference between cell and gene therapy (CGT) products and other biotherapeutics is their curative potential which often implies that speed to clinic and market is a critical milestone for CGT sponsors in order to address existing disease populations. This leads to an added emphasis on streamlining of the technology transfer process for new products into a contract development and manufacturing organizations (CDMO), also known as new product introduction (NPI). Although technology transfer and process validation of biotherapeutics are performed routinely in the industry and are very well established, there are several considerations that are unique to CGT and if discussed early in the NPI process could help align expectations at an early stage and reduce the risk of unplanned disruptions during transfer.

This paper presents a common understanding and proposed ownership of these unique aspects, developed via a consensus of CGT sponsor (client) and CDMO participants in the Validation workstream of BioPhorum Cell and Gene Therapy.

The recommendations in this paper are broken down into key topics related to the activities that are unique to CGT and suggests who should own the activity. This high-level guidance describes how, during the collaborative transfer process, the weight of responsibility is distributed between the sponsor and the CDMO, rather than providing a detailed breakdown of responsibilities and accountabilities. For ease of reading, the recommendations are presented as a series of tables rather than narrative. These tables may also be used as a check list to help ensure all critical CGT considerations are covered during initial sponsor-CDMO discussions.

With over 1000 CGT developers worldwide, the FDA expects to approve 10-20 CGT products per year annually from the year 2025. Based on this information, there is an industry emphasis on streamlining the technology transfer process for new products into CDMOs. There are many considerations that are unique to CGT and if discussed early in the NPI process, could help reduce the risk of unplanned disruptions and align expectations in the early stages.

These recommendations could serve well as pre-established expectations or as an agenda for an NPI–kickoff meeting upon the initiation of a CGT sponsor CDMO relationship. The recommendations could also be used to support master supply agreement and quality agreement discussions.

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