A technology transfer (aka “tech transfer”) for cell therapy manufacturing is the transmission of knowledge, experience, specifications, procedures, and other critical data to another organization/facility, such as a contract development and manufacturing organization (CDMO) with the goal of establishing new manufacturing capacity. This is a critical process in any contract manufacturing agreement—without it, the CDMO cannot begin the cell therapy manufacturing process.
Part of our technology transfer process is the hands-on training of our personnel in your cell therapy manufacturing process. This hands-on training may take time and effort, but it helps ensure that there are no mistakes or misunderstandings of how the process is supposed to work.
This, in turn, helps ensure that we can “hit the ground running” to put your cell therapy manufacturing process to work as soon as possible. Of course, we can adjust this process as needed to better suit your unique needs. We will work with you every step of the way to ensure that your cell therapy product is consistent and that there are no issues that may negatively impact the commercialization of your product.
This training consists of four steps.
Our team undergoes paper training to gain familiarity with all existing process documentation.
Your team observes our hands-on training with your cell therapy process and equipment to help ensure there are no errors.
After training is done, our team performs the process under observation from your team’s subject matter experts.
Our team performs several engineering runs of the process in a cleanroom environment—evaluating changes to the master batch record and analytical protocols after each.