A national biomedical research agency requested Alacrita’s support with (1) a technical assessment of the agency’s own internal capabilities in AAV manufacturing, (2) a global landscape of current and emerging providers of AAV manufacturing, and (3) an evaluation of the key bottlenecks in AAV manufacturing and any innovative solutions developed to mitigate such bottlenecks.
Alacrita consultants initiated a technical review of the client’s current AAV biomanufacturing capabilities by conducting interviews with principal investigators (PI) within the agency. We compared and contrasted these PI’s capabilities with industry-established norms to identify any potential shortcomings in the client’s AAV technical capabilities and provided mitigation strategies. A global market landscape of AAV biomanufacturing providers (both academic and industry) was assembled in a database and included details of each manufacturer such as capsid serotypes and any additional services offered, AAV production batch sizes, existence of proprietary platforms, and a summary of any novel technologies. Finally, we highlighted the critical bottlenecks in AAV manufacturing with respect to their impact on “time to market” and detailed any potential solutions either in development or in use.
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