RE: Rise6 Mar 2019 12:58
Scale-up and large-scale production
Asked about industrial-scale manufacturing, Nigel assures me that Nuvec has been developed with a scalable process using standard technologies. βWe know it can scale-up very easily. Weβve now gone from 0.5 g in the lab to a continuous preclinical manufacturing step of 17 g that takes 4β5 days, but the process that weβre using to make that amount is just a series of vessels. We want to move up to 250 g and, fundamentally, itβs just about bigger vessels,β says Nigel.
βAt the moment,β he adds, βweβre talking to some tech transfer partners about expanding into a GMP-capable facility. We donβt need GMP-grade product, just yet, but considering there are about 6 million, billion, particles (or something like that) involved in the 17 g production step, thereβs a lot of material to work with; and, if you look at the doses that people are using for DNA and RNA treatments, supplying our particle at the scale required is not going to be a problem.β