Known as Process 2.0, the new process will be used to manufacture adalimumab drug substance in Alvotech’s DSM2 manufacturing suite in Reykjavik, Iceland. The increase in output is achieved without changing the upstream manufacturing scale.

The Icelandic biosimilars company made the improvement through targeted process development, process transfer, and validation. It also showed that the new process is comparable to the previously approved one, with product quality, safety, and efficacy maintained.

The approval follows the FDA’s recent approval of additional manufacturing capacity at the Reykjavik site.

“More than doubling drug substance output per batch while maintaining product quality is a significant achievement that reflects the expertise of our process development and manufacturing teams,” says Joseph McClellan, Chief Operating Officer, Alvotech. “The new process allows us to manufacture the same quantity of drug substance in fewer batches, freeing up capacity to support other products in our portfolio, making better use of our existing infrastructure and giving us greater flexibility to respond to growing demand.”