Product Stewardship Throughout Your Cell Therapy Clinical Development
Courtney LeBlon, Ph.D., Associate Director, Head of Manufacturing Development | September 6, 2018
Product stewardship is a vital part of any cell therapy technology transfer and/or clinical development. The basic definition of product stewardship is the technical ownership of a client’s product by a specific individual. This person, the product steward, is charged with looking out for the best interests of the product itself and making decisions that improve the odds of the product’s long-term success and commercial viability.
With a product steward in place, when a cell therapy developer outsources their product’s development and manufacturing, they’re not throwing it over the wall—they’re handing it off to an expert who is guiding the lifecycle of that product. Additionally, they’re making sure that, as the product goes through the tech transfer and moves through clinical trial phases, it is staying within specification by design.
Many cell therapy developers want the reassurance of having a “person in plant” to serve this role by ensuring that products stay within specification and remain clinically viable. It’s only natural for developers to be initially uncomfortable with the lack of control that may occur when transferring their products to a third-party contract development and manufacturing organization (CDMO)—having a product steward at the CDMO in place helps to alleviate these concerns by assigning a resource who can mitigate any loss of control and apply the proverbial brakes when and if critical changes to the manufacturing process are needed for the good of the product.
Why is Product Stewardship Important?
Having a product steward to manage your cell therapy’s clinical manufacturing development and manufacturing is important because it gives the developer a surrogate within the CDMO who will look out for the best interests of the cell therapy product.
There are potential costs associated with not having a dedicated steward. For example, if you don’t have adequate stewarding throughout the product lifecycle, there can be gaps in the process—gaps that can compromise its long-term viability and that require additional development and comparability studies late in the game.
Finally, product stewards help enable the continuous improvement of a cell therapy—improvements which need to take into account the restrictions of a heavily regulated industry.
What Are the Most Important Hallmarks of an Effective Product Steward For Your Cell Therapy?
The product steward must understand the process and product on a deep level. This includes knowing the unit operations, why they’re there, the critical quality attributes (CQAs), and the quality target product profile (QTPP)—which the steward should help create it if it doesn’t already exist.
Making sure the product steward is “one with the data.” The product steward needs to have a thorough understanding and ability to keep track of the data resulting from the manufacturing process so they:
Identify when the data changes; and
Whether such changes are an oddity or an emergency.
There needs to be a realization that product stewardship is not an activity that is done for a set period of time—it’s a continuum. There may be peaks and valleys in intensity for this activity (notably as the product moves in and out of different clinical trial phases), but it never really stops.
Creating a strong trust between the product steward and the client. The client must feel that the steward knows their product intimately and knows what is needed for clinical and commercial success.
Is remembering that product stewards are multifunctional people. They need the work cross-functionally with operations, quality, validation, facilities, and so on, to fulfill their role.
One final aspect of product stewardship to keep in mind is that the longer someone works as a product steward, the more likely they will be to excel at the role. Experience is an important aspect of product stewardship because the industry does not currently have the academic-based training for this role. Rather, product stewards have to learn this role on the job. Ideally, product stewards should have experience from both from the operational and development side of cell therapy manufacturing. This helps them form a more holistic view of your cell therapy product and know how to best resolve conflicts between these two sides.
If you need help with ensuring that your cell therapy products are protected and positioned for future success, contact the PCT team today to learn more about product stewardship and the steps necessary to prepare your product for commercial viability.
Courtney LeBlon, Ph.D., Associate Director, Head of Manufacturing Development
Subscribe to our blog for instant updates on challenges and trends in cell therapy development, manufacturing and commercialization.