Technology Transfer

What is a Technology Transfer?

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.

The Experience Needed to Make Technology Transfers Fast and Easy

The PCT service platform team, which is now part of Hitachi Chemical Advanced Therapeutics Solutions (HCATS), has performed more than 45 successful technology transfers for cell therapy products in different clinical trial phases. Our systematic and strategic approach to the tech transfer process and cell therapy manufacturing has helped us successfully over 45 of cell therapy production processes to our facilities without impacting their characterization or creating significant delays.
 
Best of all, with our technology transfer process, we don’t take the project over and claim ownership of the cell therapy product, or any of the IP needed to manufacture it. It’s your product, your process, and your data to do with as you want.

 

The PCT service platform team knows:
  • The critical challenges that may impede the successful transfer of a cell therapy manufacturing process;
  • What phase-specific documentation is needed to align with both national and international regulations;
  • The phase-specific characterization requirements for the cell therapy product;
  • How to coordinate the technology transfer with your team for maximum efficacy;
  • What business milestones to establish concerning the transfer;
  • How to achieve global harmonization for a cell therapy product so that it can achieve maximum commercial viability;
  • How to use closed systems and automation to manufacture for each market in either a centralized or regional manufacturing capacity; and
  • How to resolve the ownership of any intellectual properties that may arise as a result of the contract manufacturing agreement.

Ensuring Accurate and Consistent Cell Therapy Production

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.

 

Step 1:

Our team undergoes paper training to gain familiarity with all existing process documentation.

Step 2:

Your team observes our hands-on training with your cell therapy process and equipment to help ensure there are no errors.

Step 3:

After training is done, our team performs the process under observation from your team’s subject matter experts.

Step 4:

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.

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