We are weighing outsourcing vs. producing our rAAV in house. Could you talk about thoughts for each.

Answer

There are several factors to consider when weighing whether to outsource or produce rAAV in-house—almost too many to expand on in detail in this forum. Importantly, all steps from plasmid generation to upstream cell culture and transfection through downstream purification and analytics must be factored into the decision. Some of the major factors to consider include: project timelines, the volume/titer needed versus your capacity to produce (i.e., what scale can your facility handle?), short- or long-term needs, research-grade versus GMP, cost in both materials and labor, application for the viral particles, and available expertise to design and troubleshoot the production and analytics. In the end, it comes down to a question of whether it is better to relinquish control of the process for the sake of efficiency or it is necessary and worth the investment of time, money, and resources for your specific application to produce in-house. For one perspective, the following article discusses the rationale of one company behind establishing in-house manufacturing: Markarian J. “Finding Success in AAV Manufacturing”. BioPharm International 2021;34(3):34–37.