Jaleesa Bresseleers received her M.Sc. in Molecular Life Sciences from Radboud University in 2013. During her master’s she worked on both capsid protein nanoparticles for the creation of nanoreactors in the Bio-Organic Chemistry group of Prof. Jan van Hest at Radboud University, and protein hydrogels for the development of a stress sensor in the group of Prof. David Tirrell at California Institute of Technology. Currently she is a Ph.D. candidate working on GMP production of nanomedicines in a company: ChemConnection under the supervision of Prof. Jan van Hest.
Development of scalable processes for the GMP manufacture of nanocarriers
Recent advances in the development of nanotechnology in medicine is providing mankind with exceptional promising tools. So-called nanomedicines can be defined as therapeutic, diagnostic and theranostic agents with diameters ranging from 1 nm to 1000 nm. Their applications provide significant possibilities to target diseases on a molecular level, which allows for more selectivity and efficiency in therapies.
Even despite their huge medical and economical potential, there are still a couple of hurdles that typically arise in the development of nanomedicine. Once discovered, one of the very challenging hurdles is the adaptation towards the pharmaceutical industry: their reproducible, efficient and scalable GMP production. For this reason, the focus of this research will be on the preparation of robust and scalable manufacturing processes for the production of biodegradable nanomedicines and their building blocks that possess the characteristics to be clinically relevant. To achieve this, both batch and continuous flow processes will be developed and evaluated for the manufacture of highly potent materials. The development of these nanomedicines not only entails their preparation but also includes purification, reduction of production costs and the implementation of analytical methods to characterize the products. The main idea is to develop scalable routes towards a final nanomedicine product which is then tested for appropriate drug release, biodegradation and toxicology. Also investigation regarding shelf life, regulatory issues and safety issues will eventually readily translate into the GMP manufacturing of a clinical product.