Few CMOs equipped to manufacture cell and gene therapies, finds study

A new report has found that more than 7,000 cell and gene therapies will progress through the development pipeline, but only 152 contract manufacturing organisations (CMOs) have the capabilities to manufacture them. According to Globaldata, which conducted the research, this will result in production bottlenecks.

The report highlights that these bottlenecks will be a major obstacle to large-scale commercial manufacture once more Advanced Therapy Medicinal Products (ATMPs) are approved.

The report says that currently, 79 of these cell and gene therapies are for COVID-19, although the majority of these are in their pre-clinical and discovery phases of development. Two of them are in Phase III, Mesoblast’s remestemcel-L and Athersys’s MultiStem, with another 15 in Phase II. If these are approved, they will need to be scaled up and manufactured quickly to treat the current pandemic, the researchers emphasise. 

Adam Bradbury, PharmSource Analyst at GlobalData, commented: “There are considerable opportunities for CMOs with the capability to manufacture ATMPs. However, only 152 CMOs have the capability to produce cell or gene therapy APIs for global markets and of these only 121 are dedicated CMOs. Producing gene or cell therapies requires an inherently high level of manufacturing expertise and expensive facility requirements that many pharma companies do not possess.”

“With a large number of ATMPs in the drug pipeline greater numbers will be approved. This will require improvements to the production process and the removal of manufacturing bottlenecks to create cost-efficient manufacture at a commercial scale,” said Bradbury.