The right timing to initiate your new product development

Developing a new cell therapy product is a journey, and like any other journey, the right planning and timing of activities make the journey a success. I will attempt in this post to provide a big-picture view of cell therapy product development process, and then discuss some essential points.

Stages of Product Development

Cell therapy product development goes through main stages, and few complementary activities; the complementary activities overlap multiple stages to be completed at the right timing.

Stage 1. Technology Transfer

At this time the product is developed (at the research level) by researchers, where they demonstrated the product’s feasibility and pre-clinical safety. This is the beginning of the translational research where the process is being adopted by teams of the translational labs to develop it into a clinic-suitable & at-scale process.

Stage 2. Implementation

Once the production process is developed by the translational labs into a standard form, it is ready to be implemented. At this stage the standard operating procedure (SOP), production documents, material specifications, and equipment are finalized and are ready for final approval. Also, at this stage the training of personnel on clinical production of the new product begins.

Stage 3. Pilot Studies

This is the stage where the new production system (process, documents, equipment, facility, personnel) is being tested. At this stage the new cell therapy product is produced by the trained personnel in the production facility and using the finalized documents, material, and equipment. The final product(s) of this study goes through the testing and approval using the approved analytical methods and release criteria.

Stage 4. Going Live

When the results of the pilot study are satisfactory, the process is approved and the documentation is completed to make the process ready for clinical production. When the clinical study goes live, patients are recruited to receive the new product as their therapy.

This is a general overview of product development, but there are product-specific variations that may make the details of some stages a little different. Additionally, there are some considerations during the planning stage that make the product development a successful one.

Planning Effectively

A. Process-Related

I have discussed the facility considerations in another post, I will not repeat that here. I will though stress on the critical impact of the complementary activities timing on developing a more than minimally manipulated (MMM) process. MMM production requires a GMP facility, the building of which is time consuming. Therefore, construction need to be initiated early on and overlap the initial stages. Such a planning saves your institution a year or more worth of time which is significant cost considering the wasted production time. By the time the facility is ready, Stages 1 and 2 of the product development would be completed, and is ready to move to Stage 3 in the new facility.

B. Capacity

When you develop a product that is anticipated to face a high demand, you need to consider hiring and training more personnel, which is also a time-consuming process. To be ready at the right time, personnel hiring and training should be initiated very early in the process. Additionally, you would need to build a suitable stock of materials to ensure uninterrupted production. 

In short, plan well and consider the anticipated production volume and nature, you will save a valuable time, and save your institution the cost of correcting or expanding the facility. If you plan on building your facility 3 years from now, then your product development should start now. Similarly, if you are just starting your product development, it is the right time to initiate the GMP facility construction.

Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us. 

About the author

Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here