Description
The NanoAssemblr™ Blaze™ and Blaze+™ systems enable the process development of LNPs including early CMC studies and large-scale protocol development of upstream and downstream operations, providing valuable insights into processes and consumables required for GMP manufacturing.
- Efficient: Verify end-to-end clinical manufacturing processes including tangential flow filtration (TFF), sterile filtration, and fill/finish operations on a preclinical system with a simplified setup and shorter run times, saving time and resources.
- Flexible volume: Select Blaze™ for low-volume applications of up to 1 L or upgrade to Blaze+™ for high-volume applications of up to 10 L, enabling toxicity, stability, and large-cohort in vivo animal studies.
- Closed system environment: Assess manufacturing processes in a closed system environment on the Blaze+™ system, which enables external vessel connections and includes a software upgrade, minimizing risk during scale-up.
- Scalable: Efficient technology transfer of critical process parameters (CPPs) to the NanoAssemblr™ commercial formulation system and a cGMP facility.
- Reproducible: NxGen™ technology ensures controlled mixing conditions, resulting in consistent flow rates for robust particle formation.