Celsion Receives FDA Guidance For Company’s CMC

Celsion has received positive guidance for company’s Type C Chemistry Manufacturing and Controls (CMC) from FDA.

The FDA has provided the company with the oral and written guidance that permits Celsion to implement and validate process improvements to the manufacturing methods used to produce ThermoDox.

ThermoDox, the company’s lead product in a global Phase III clinical study for primary liver cancer.

Based on FDA’s guidance, thecompany intends to move forward with its plans to scale up the ThermoDox manufacturing process so that larger, more economical batches can be manufactured at quality levels that support commercial launch plans.

Michael Tardugno, president and CEO of Celsion, said: FDA’s guidance and continued willingness to collaborate with Celsion is very much appreciated. Our close consultation with the FDA’s CMC group from the start of ThermoDox’s development has allowed us to successfully mitigate the risks common to CMC programs. We now have well defined clinical, regulatory and manufacturing pathways to commercialization and are pleased to be taking the proper steps to ensure manufacturing capacity is in place to support product launch.