This is the second in a three-part series (Part 1 can be found here).
As you enter this mid-phase of development, we reflect on these words from Albert Einstein: “In the middle of difficulty lies opportunity.”
If you are a cell therapy developer in Phase 2 or 3 of clinical development, you’ve already overcome some key hurdles toward bringing your therapy to market: you’ve defined the quality target product profile and are (hopefully) working with a manufacturing partner that has expertise in cell therapy and can help optimize your manufacturing process in a way that takes into account quality, cost of goods, scalability, and sustainability (collectively, Development by Design, or DbD). You know now that planning around these elements early is an investment that will pay off in the long run. So what’s next?
A critical aspect of cell therapy development is the transfer of knowledge from the sponsor or another manufacturing organization to the manufacturing organization that will bring the product to commercial scale. In general, technology transfer to a CDMO is advised when a cell therapy developer requires the resources, capacity, facilities, and/or expertise directly relevant to cell therapy in order to meet industrial and regulatory requirements needed to advance their therapy toward commercialization. So it is essential for a sponsor company to evaluate the strategy, timelines, and infrastructure necessary for a successful and streamlined technology transfer. If you have not yet transferred your technology to a manufacturing partner that is prepared to take your therapy through to commercial-scale and beyond, prior to Phase 2 is the time. While some cell therapy developers may be inclined to use a CMO for early-phase development and take manufacturing in-house for commercialization based on the perception that this will result in long-term cost savings, the unpredictable nature of cell therapy market demand means that transferring to a CMO for commercial work to cope with peak demand (and/or to handle excess demand that an in-house facility does not have the capacity to meet) is one strategy to keep costs down and mitigate idle capacity risk. Additionally, partnering with a CMO can help a developer decide when to spend the capital for its own facility and at what level of risk. The earlier that decision is made, with minimal clinical phase data, the higher the risk.
Once tech transfer to a manufacturing partner has occurred, it is important that the partner work closely with you to develop a strategic plan for reaching commercial-scale (and commercially viable) manufacturing. Such a plan should include three primary segments:
- Clear-eyed evaluation of the current state of your manufacturing
- Detailed analysis of optimization opportunities
- Recommendation to achieving commercial readiness
Evaluation—a thorough description of the current state of the developer’s manufacturing process, including current-state descriptions of Quality Target Product Profile, Critical Quality Attributes (CQAs), and Unit Operations (UO).
Analysis—used to identify opportunities for optimization and improvement, as well as particular areas of challenge and risk. Here, strengths and weaknesses in a developer’s manufacturing process are identified in order to outline what is needed to successfully evolve from the current state to a state of commercially viable manufacturing by looking at quality, cost of goods, scalability and sustainability.
Recommendations—provided in the form of an optimization plan, based on the evaluation and analysis performed. Successful implementation of the optimization plan is needed to meet the commercial manufacturing vision of the cell therapy developer.
This sort of strategic plan for commercialization gives cell therapy developers a strategic advantage. Once the cell therapy developer has worked closely with the manufacturing partner to create such a plan, it can be implemented to optimize the manufacturing process, using strategies such as automation and integration, which keeps the elements of DbD at the forefront, setting the developer up for success through late-phase development and into commercialization.
Click the image below to download the complimentary article, "Mapping Success for Commercial Cell Therapy Manufacturing."
