Thanks for your thoughts about commercial manufacturing. There has been some great news and discussion recently about manufacturing this cell-based pharmaceutical product at large scale. Capacity to manufacture is crucial and the acquisition of the Flaskworks technology was a brilliant move by the company. Thanks for highlighting these topics. I can’t wait to hear more news about manufacturing DCVax-L.
The MIA is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
LP said that the UK facility can supply North America, but they will likely use the Memphis facility too depending on money/timing. Either facility should have enough capacity to stand alone, but they could use both.
They have been planning well to build the capacity to address a worldwide demand.
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