A great chef could create an outstanding dish that revolutionizes cuisine – every time they prepare the recipe for two, it may come out perfect and impress everyone who tries it. However, they would probably struggle to reproduce the same show-stopper dish with the same flavour, texture and taste on a large scale when cooking for a crowd. Something similar happens when scientists develop a new drug: some of the desired characteristics of the medicine obtained in the laboratory at a small scale might be difficult to recreate when the same drug is manufactured in industrial quantities for the market.
This is especially true when developing nanomedicines like the New Deal therapy for inflammatory bowel disease (IBD). For these cutting-edge treatments, large-scale industrial production can be a major challenge that may affect important characteristics of nanoparticles, such as size, stability and surface morphology. Therefore, it is crucial to ensure that parameters that are essential for the biomedical efficacy of the nanoparticle remain intact through the industrial scale-up process.
There are many factors that influence in scaling-up, including the nanoparticle material, the method of production or the cost and time invested, among others. That is why the New Deal project recently organized an online workshop titled “Translational issues in nanomedicine” on 15th October 2020 along with the European Technology Platform on Nanomedicine (ETPN) 2020 Conference and three ‘sister projects’ working in nanomedicine in Europe – B-Smart, Cupido and Smart4Fabry. The event brought many experts together, making it a perfect occasion for discussing the main challenges in translating nanomedicine initiatives from the bench to the bedside. One of the topics of debate focused on the practical issues during the crucial scale-up step while producing nanomedicines in large volumes.
As part of the workshop, Fabien Montury, NanO´up platform leader at the CEA at Toulouse (France) and our New Deal partner, enumerated the key factors that researchers need to consider while translating nanoparticle production from the lab to large volumes. For starters, scientists have to ensure a sterile environment to avoid any contamination with the final product. Further, they need to consider heat and mass transfer, to be able to substitute the simple processing operations that are involved in the laboratory-scale. Finally, the safety of the operators and workers also needs special considerations given the large volume, energy and mechanical steps involved.
Fabien later explained how the usual issues during the scale-up process have been tackled within the New Deal project – “The key is to identify all the crucial parameters that need to be scaled-up and proceeding step-by-step. All experiments need to be repeated many times at each scale to ensure maximum reproducibility”. He further insisted on the importance of employing the right validation and characterization methods that allow comparison between the different scales of production. “It is essential to ensure that all industrial and regulatory constraints are anticipated from the very beginning at the lab-scale so that there are no surprises later on”, he adds.
Thanks to Fabien and all partners, the New Deal project can expect to have a cutting-edge therapeutic nanomedicine for IBD produced on an industrial scale without any hiccups.