In a recent article, we discussed some of the major telltale signs that your cell therapy product might not be ready for a technology transfer. To be successful, a cell therapy technology transfer needs to have:
- Exhaustive documentation;
- The full support of staff on both sides of the transfer;
- Clear communication channels between both sites;
- A well-defined product;
- An understanding of the developer’s business milestones; and
- Clear ownership of any intellectual property involved in the therapy and the processes used to manufacture it.
Considering the difficulty and expense involved in performing a technology transfer, why would it be worth the effort? What reasons are there to risk entering a partnership with a contract development and manufacturing organization (CDMO) to manufacture your product?
Here Are 5 Reasons To Perform A Technology Transfer
1: To Increase the Distribution Area of Your Product
Many cell therapy products have an extremely short “shelf life” due to the need for delivery of a fresh (not frozen) final product, meaning the production area has to be located relatively close by to where the treatment occurs. Adding more production centers by performing a technology transfer increases the area in which you can distribute your cell therapy product.
Additionally, an experienced CDMO might have facilities, distribution channels, and equipment that your own organization might not. For example, a CDMO might have access to a cryopreservation process that is compatible with your cell therapy product—greatly extending the shelf life of your therapy.
2: To Help You Manage Capacity Challenges
Sometimes, a manufacturing facility might not have the capacity needed to keep up with demand for a given cell therapy product. Adding new facilities by partnering with a CDMO can resolve this issue without forcing you to incur the risk of paying for an internal expansion that you may sit idle for a time after your next clinical trial completes.
Idle capacity may be a significant problem for commercialized cell therapies as well —such as when there isn’t enough consistent demand for the cell therapy product to warrant maintaining your own internal production facility year-round. As these facilities sit idle waiting for orders, you waste money on keeping the facilities ready to go, but without earning any revenue in return.
Here, outsourcing to a CDMO can save you money, since they can handle production when there’s demand for your product, and switch to other products when demand is low. This way, you’re only paying for the production capacity you need as you need it.
3: The Quality Problems at the Current Manufacturing Site
It’s unfortunate, but there are times where a developer’s current manufacturing facilities (or partner) might not be able to meet critical quality targets needed to ensure the commercial viability and safety of your cell therapy product. This can cause a number of problems—not the least of which is the production facility getting shut down by Occupational Safety and Health Administration (OSHA) or U.S. Food and Drug Administration (FDA) inspectors.
In such cases, it may be necessary to perform a technology transfer to another manufacturing partner who can resolve cost and quality issues.
4: To Acquire Later-Stage Manufacturing Expertise
Some contract manufacturing organizations are specialized in early-stage manufacturing processes, but lack experience for later-stage development for commercialization or do not have facilities that meet the quality or capacity requirements for commercial manufacturing. Here, you may need to transfer your process to a manufacturer who has more experience and expertise in achieving commercially viable manufacturing.
Some things to look for when examining potential partners for later-stage manufacturing expertise include the CDMO’s ability to:
- Implement Development by Design (DbD) principles;
- Automate processes when appropriate;
- Create closed systems; and
- Use cryopreservation and robust supply chains to optimize the distribution of cell therapy products.
An experienced CDMO partner can recommend and implement process changes to reduce cost of goods (COGS), as well as optimize your process to ensure sustainability and scalability, while still maintaining a high quality product.
5: To Create Redundancy
Sometimes, risk mitigation plans may call for an available spare/back-up manufacturing facility for a cell therapy product to maintain production in case something happens to the primary facility. For example, if one site is closed down because of a natural disaster or failed inspection, production of your cell therapy product can continue at the second location without excessive interruption.
This redundancy in production helps to protect your product against shortages in case of an emergency. By transferring to a CDMO on an “as needed” basis, you can help keep your costs down while creating this redundancy—which is significantly less risky than trying to create redundancy by building new facilities internally.
Any one of the above reasons can be enough to justify the time and trouble it takes to complete a cell therapy technology transfer.
Need help evaluating the next steps for a technology transfer of your cell therapy product? The PCT services team experts have extensive experience in helping cell therapy developers transfer their cell therapy products to their sites in a way that minimizes risks and helps ensure that the product matches its defined parameters and quality targets. Contact us today to get started!
