As more than 7,000 cell and gene therapies progress through the development pipeline and only 152 CMOs have the capabilities to manufacture them, production bottlenecks are the major obstacle to large-scale commercial manufacture once more Advanced Therapy Medicinal Products (ATMPs) are approved, says GlobalData, a leading data and analytics company.
Currently, 79 of these cell and gene therapies are for COVID-19, though the majority of these are in preclinical and discovery phases. 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.
Adam Bradbury, PharmSource Analyst at GlobalData, comments: “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.”
Bradbury continues: “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.”