Our work package structure enables to tackle current challenges for bionanoparticle manufacturing.
The production, loading and characterization of bionanoparticles are essential steps in the development and manufacture of new bionanoparticle-based medicines. Stress exerted during manufacture – especially unit operations in downstream processing – might change the integrity of the bionanoparticle and impact the efficacy and safety of the bionanoparticle-based medicine.
Characterization of single particles and particle ensembles
Objective: To develop and provide suitable analytical tools to study the composition of bionanoparticles and understand how the downstream process influences their composition.
- DC1: Mass spectrometry-based techniques for determination of bionanoparticle composition
- DC2: Integrity of encapsidated genomic material and protein expression
- DC3: Multidimensional characterization of bionanoparticles
- DC4: In-line quality control of single particles in nanodevices
- DC5: High resolution analysis of single particles
Process analytical technology, data analysis and modelling
Objective: To develop process analytical technology (PAT) methods for bionanoparticle processing, to model the bionanoparticle trajectory in different DSP processes with different methods (including CFD), and to use molecular modelling to assess the stability of vector systems.
- DC6: Multisensory in-line PAT in DSP for in-silico model-based process monitoring and control
- DC7: Investigation and PAT development to analyze integrity and stability of VLP and AAV during processing
- DC8: Model-based prediction of bionanoparticle separation by continuous ultracentrifugation and convective chromatography
Recovery of bionanoparticles – harvest, batch and continuous processes
Objective: To understand the impact of in-vivo assembly, harvest, purification and transition between unit operations on stability and quality.
- DC9: Engineering of in-vivo RNA loading in vesicles
- DC10: Development of technology for the bionanoparticle production to facilitate optimal DSP
- DC11: Separation and purification of bionanoparticles by convective material and 3D printed material
- DC12: Separation and purification of bionanoparticles by continuous-flow ultracentrifugation
- DC13: Impact of continuous downstream process in complex biotherapeutic bionanoparticles manufacturing
- DC14: Scale-up strategies for purification of bionanoparticles
