10.1 Study Methodology
10.1.1 We performed a comprehensive search to find all firms worldwide that manufacture cell therapies on a contract basis. We have included firms that perform CAR-T, CAR-NK, MSC, or other types of therapies. Because cell therapy manufacturing isn’t dependent on bespoke vessels, categorizing the capacity by volume isn’t always possible. We have included specific vessels where this information is available, but most cell therapy manufacturing is dependent on cleanroom space and/or the number of suites. This information is included where available.
10.1.2 To create this report, we reached out to every single firm listed in this profile section. We spoke with some on numerous occasions to create the rest of the report, but many were simply contacted by us with a request to confirm the profile presented here. The firms that returned our request are noted with the company verified check mark.
10.1.3 Some additional notations on how we categorized information to create each profile:
Tech transfer is not typically called out in the service capabilities, so we have generally left it out of the profile capabilities unless the firm highlighted this activity in their materials or our discussions with them.
“Additional Services and Capabilities” includes detailed explanations of some services that we believe may interest the reader. For example, we listed specific cell therapy types such as MSCs, HMCs, iPSCs, or CAR-T.
We generally assumed that companies that perform cell line development and process development also perform cell banking, although the firm may not always specify this.
Locations given are only those where cell therapy process development or GMP manufacturing is performed. When the firm also has additional capabilities, such as viral vector or mammalian biologics manufacturing, but the segregation among different plants isn’t clear, we listed all the plants.
New for this year, we indicated in our master table whether the company performs late-stage manufacturing or commercial-ready manufacturing activities. This indicates that the firm performs pre-BLA activities such as process characterization and PPQ runs. If it isn’t clear that the firm actively performs commercial manufacturing at their site, we checked the “commercialization” box but not “commercial manufacturing.” Similarly, if a company states they can do commercial manufacturing but makes no mention of the preparative activities, we have not checked the commercial-ready box but have checked the “commercial” box. Locations given are only those where cell therapy process development or GMP manufacturing is performed.