CDMOs can assist clients in easing the demand for commercial cell and gene therapy manufacturing in this challenging and expanding market. Demand exceeds supply in the cell and gene therapy manufacturing space, which is well-known in the field. Several field developers have built manufacturing facilities to manufacture its cell and gene therapy (CGT) pipeline products for clinical and, ideally, commercial use.
The percentage of cell and gene therapy companies that outsource CGT manufacturing is predicted to fall from 44% to 22% over the next five years. This is especially true as their products get closer to commercialization, according to recent findings from Industry Standard Research (ISR), which focuses on pharmaceutical trends.
Although it makes sense for developers of cell and gene therapies to desire to maintain control over their manufacturing course, there are drawbacks to this strategy that should be taken into account.
Why do Developers Maintain In-House Cell and Gene Therapy Manufacturing?
Let’s look at a few factors that so many CGT developers cite as reasons for wanting to bring their manufacturing in-house first.
Experience
There is a learning curve to integrate new groups conducting the production process and analytics because each CGT product is often unique. Some businesses believe their team is the most qualified to manufacture the product because they understand their production process and analytics.
But consider this: To support clinical and, ideally, commercial manufacturing, some businesses have developed cell and gene therapy manufacturing facilities. However, even small facilities require large capital inputs that can reach millions of dollars.
Once a facility is constructed, businesses must find employees to run it, which is difficult in a market where turnover is often high, and skill is scarce. Depending on the size of the facility, operational needs (staff, facilities, etc.) vary. Still, monthly operational burn rates in the seven-to-eight-figure range or higher are not unusual.
Retaining control over the timeline of their manufacturing is one of the main reasons businesses choose to construct their own facilities. Another justification is the potential financial savings of insourcing. Companies should include expenses associated with building facilities, qualifications, locating, recruiting, and maintaining talent, as well as idle capacity costs, when determining cost savings.
High utilization of manufacturing facilities is essential for CDMO operations since it lowers facility and labor expenses. Much of a GMP production facility and the associated manufacturing teams may be idle if facility utilization is not considered.
If teams only sometimes carry out the manufacturing processes for contract manufacturing organization cell therapy, it will cost more to retrain the manufacturing teams. Early clinical production proceeds relatively slowly, especially for Phase I. Therefore, companies should work with the clinical operations teams to establish the projected rate of manufacture because this is crucial for determining facility size.
Time
Companies consider in-house manufacturing as a way to accomplish their objective of advancing their pipeline medications as quickly as possible, particularly at the clinical (and hopefully commercial scale).
When considering the construction of an internal facility, timing is another crucial factor. This might have appeared like an unnecessary addition to the list in the past because businesses’ willingness to spend money corresponded roughly with how swiftly development progressed.
However, this is not the case because COVID hampered supply networks. For instance, electrical, control boards, and generators have lead times greater than a year. Even the best-planned construction projects could take an extra year or two. Construction costs have increased significantly per square foot in addition to inflation.
Privacy
Because they have invested a lot of effort in creating unique CGT treatments and think certain product qualities constitute proprietary or trade-secret know-how, many medicinal developers in the CGT area subscribe to the adage – the method is the product.
Final Words
We want to end this write-up by saying it would be advantageous for businesses to collaborate with CDMOs in these circumstances to help them manage the demand for commercial cell and gene therapy manufacturing.
When a business reaches the commercial stage, it can consider constructing a modest facility and relying on CDMO manufacturing for excess production and regional expansion.
