. 2022 Sep 29;7:54. doi: 10.1038/s41536-022-00242-7

Table 2.

A comparison of in-house banking, facility rental, and CMO options for hPSC biobanking and control of COGs.

Considerations	In-house biobanking	Facility rental	Use of CMO
Advantages	Maintain control over know-how (staff training and development, protocols, intellectual property (IP) etc.), quality management, and facility access. In theory this enables greater flexibility and smoother progression).	Fee per service can reduce costs of in-house set up and maintenance, enable quicker start up times and will not affect or be affected by, other institutional activities.	Sponsor institute does not have to build appropriate facilities or recruit regulatory, QA, and manufacturing staff. Manufacture can run unaffected by sponsor institution activity
Disadvantages	long lead-in time and high cost to build and staff the facility. Ongoing costs of facility maintenance, regulatory compliance, and ultimately facility replacement after ~20years (or as little as 5 years as required in Japan).	Core staff may need to be taken away from regular duties to run the facility or recruit and train dedicated staff which also adds to cost. Need to align quality management systems and operational aspects of the facility provider and product developer. Access may need to be negotiated years in advance.	Risk of an unsuccessful and costly technology translation process requires time commitment for careful preparation of documentation, reagent supply pipelines, and comparability between CMO and product developer processes. Potential loss of know-how and potential IP due to technology transfer to CMO. Loss of control of the manufacturing process.
Crucial consideration	The ongoing costs of maintaining the facility and staff should be considered as part of production life cycle and longer-term development plans.	The manufacturing process should be worked out completely prior to transfer to the rental facility to avoid extended rental periods increased.	The manufacturing process should be worked out completely prior to transfer to avoid high CMO costs and potential loss of in-house IP.

Considerations

In-house biobanking

Facility rental

Use of CMO

Advantages

Maintain control over know-how (staff training and development, protocols, intellectual property (IP) etc.), quality management, and facility access. In theory this enables greater flexibility and smoother progression).

Fee per service can reduce costs of in-house set up and maintenance, enable quicker start up times and will not affect or be affected by, other institutional activities.

Sponsor institute does not have to build appropriate facilities or recruit regulatory, QA, and manufacturing staff.

Manufacture can run unaffected by sponsor institution activity

Disadvantages

long lead-in time and high cost to build and staff the facility. Ongoing costs of facility maintenance, regulatory compliance, and ultimately facility replacement after ~20years (or as little as 5 years as required in Japan).

Core staff may need to be taken away from regular duties to run the facility or recruit and train dedicated staff which also adds to cost.

Need to align quality management systems and operational aspects of the facility provider and product developer.

Access may need to be negotiated years in advance.

Risk of an unsuccessful and costly technology translation process requires time commitment for careful preparation of documentation, reagent supply pipelines, and comparability between CMO and product developer processes.

Potential loss of know-how and potential IP due to technology transfer to CMO.

Loss of control of the manufacturing process.

Crucial consideration

The ongoing costs of maintaining the facility and staff should be considered as part of production life cycle and longer-term development plans.

The manufacturing process should be worked out completely prior to transfer to the rental facility to avoid extended rental periods increased.

The manufacturing process should be worked out completely prior to transfer to avoid high CMO costs and potential loss of in-house IP.