Why BioMarin took gene therapy manufacturing into its own hands

The factors behind BioMarin’s decision to build rather than buy a facility for manufacturing gene therapies.

As gene therapy companies fight for space at contract manufacturers, BioMarin has leveraged its expertise in biologics to design its own capabilities for manufacturing gene therapies and gain control of the process -- a move it thinks will set quality standards across the industry.

Demand for viral vectors continues to grow as more gene and CAR T cell therapies near the market, making the decision of whether to make or buy vectors a critical one.

It’s no longer just a matter of weighing the upfront investment of in-house production with the higher cost of goods down the line from outsourcing. Companies now need to consider the risks to development timelines and possible supply disruption as the CMO bottleneck grows (see “Gene Therapy’s Make or Buy Choice”).

For BioMarin, bringing manufacturing in-house was a no-brainer. Its experience serves as a case-study for how biologics companies can make the leap to manufacturing new modalities, building on their institutional knowledge. 

“While building a facility is not inexpensive, we know the costs and can control those.”

Robert Baffi, BioMarin

“When we were faced with the decision to invest massively into a contractor, or invest massively into ourselves, we knew we had the capability to do it internally

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