Below is an excerpt on technology transfer in cell therapy manufacturing, written by Catherine McIntyre, PhD, Director, Technical Operations, and Cenk Sumen, PhD, Manager, Technology and Business Development, originally published in the April 2015 issue of BioProcess International as part of the article, “Are You Ready for a Tech Transfer? Part 1: Challenges and Critical Factors for Success in Cell Therapy Development.”
“Technology transfer, which we defined in a previous post as the transfer of knowledge from a development organization (sponsor) to a manufacturing organization, relocates a process into a different environment. As a result, the transfer process should be properly defined before a move is initiated.
The transferring site should identify key development and clinical milestones and come to agreement with the receiving site on necessary and practical timelines. Technology transfer must be built into the overall timeline for product development and commercialization. Often, external deadlines — such as a desired investigational new drug (IND) submission date or funding milestones — can drive the timelines of technology transfer, but care must be taken to allow both parties sufficient time to successfully proceed through transfer stages. Technology transfer is a marathon, not a sprint.
Open and honest sharing of information from sponsor to CDMO is also critical for success. Process descriptions, protocols, SOPs, work instructions (WIs), and master batch records (MBRs) (if already developed by the transferring site) all contain useful information for performing a given process. However, technology transfer teams should not underestimate the criticality of unspoken and unwritten information inherent to scientists, operators, and technicians at a CDMO. The originating facility, if different from the transferring site, should also be involved to ensure capture of the full history of a process.
To develop a technical understanding of the technology to be transferred, a combined team (with members from both sponsor and CDMO) should review all available scientific and technical data and documentation. Those materials should include process development reports, a process description, SOPs, material and equipment specifications, acceptance criteria, logistics, and clinical considerations.
The CDMO also must understand biological material and final product variability, process consistency and robustness, and failure rates. The CDMO should leverage experience gained through previous technology transfers to preempt and mitigate potential risks to the success of the project.
After agreements have been made to move forward with a collaborative project, a project initiation meeting is the first major milestone in technology transfer. During that meeting, expert team members from both the transferring and receiving sites meet, transfer technical and logistic information, and lay the groundwork for a program charter. Next comes a program kickoff meeting at the CDMO site to detail the basic science, manufacturing process, analytical and testing procedures, storage, shipping, and all other technical issues specific to the project.
A program charter is a high-level document developed and agreed upon by all team members. It lays the groundwork for a program and captures all important elements in a format that is readily understandable by all members of the team implementing the program. This provides a central point of reference and formal agreement of program scope, deliverables, and constraints.
Upon establishing a collaborative sponsor–CDMO team, it is crucial to set expectations for open communication between both parties. A communication plan compiled jointly will identify the roles and responsibilities of team members at the sponsor and/or transferring site and the CDMO, summarize expectations, and provide an up‑to‑date and comprehensive list of contact information available to the team. This document should be revisited and updated regularly as a project moves between stages.
Successful technology transfer occurs when team members on all sides of the transfer develop an open and proactive relationship with their counterparts, enabling frequent and timely communication as matters arise. To eliminate redundancy and duplication of effort, important information, decisions, and discussion summaries must be circulated to the extended team.”
Table 1: Four stages of training at the transferring and receiving sites
| 1 | Receiving-site personnel undergo paper training to ensure familiarity with all existing process documentation. |
| 2 | Transferring-site personnel participate in physical observation of, and hands-on training with the process at the transferring site. |
| 3 | Receiving-site personnel perform the process under observation of transferring site subject matter experts. |
| 4 | Receiving-site personnel execute several “dress rehearsals” (engineering runs) of the process in a cleanroom environment, evaluating changes to the master batch record as well as analytical protocols after each engineering run. |
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