A manufacturing tool for making high volumes of individualised doses
The NANOme® GMP equipment, augmented by the FR-JET mixing technology, redefines back-to-back aseptic manufacturing clinical batches of individualised doses for personalised medicine.
Fully closed automated system for small formulation batches.
The only system offering a fully-closed single-use sterile fluid path with zero contact between product and reusable parts for high sterility assurance.
Direct process transfer from the NANOlab®
The process established on the NANOlab® can be transferred directly to the GMP NANOme® device without the need for intermediate scale up equipment or steps.
No need for cleaning or CIP/SIP means product changeovers take as little as 5 minutes!
An easy-to-handle disposable kit, which completely eliminates the need for cleaning, sterilization or validation steps in-between batches and saves time significantly.
Unparalleled performance, proven by data.
Example particle data generated with the NANOme® system.
Consistent process performance
High batch reproducibility
Extraordinary process stability
The process is highly consistent between our process development equipment (with the metal FR-JET) to NANOme® (with the polymer FR-JET reactor) for GMP. Data shown above using PLGA particles.
High batch reproducibility and homogeneity are crucial to ensure efficacy of the final nanocarrier products. This is achieved effortlessly with the NANOme® system. Data shown above using liposomes.
NANOme® is a pumpless system, in which fluid flow is generated by applying pressure on the fluid containers. The resulting stable flow yields highly homogeneous batches. Data shown using liposomes.
A paradigm change in manufacturing for personalised medicine.
Traditional biopharma facilities use process technologies and setups designed to reliably and repeatedly manufacture high-volume batches of identical products. In personalised medicine, however, the target patient populations are very small—sometimes as small as one, such as in autologous therapies that rely on a patient’s own cellular material as the therapeutic agent. Therefore, an ability to process a high volume of small batches is missing and before personalised medicine can become mainstream, the all-new manufacturing challenges that it poses need to be overcome. We have engineered the NANOme® to deliver on-demand upstream manufacture of personalized batches and doses of nano encapsulated drug products, while maintaining quality to solve the current key issues ATMP manufacturing.
The closed disposable system enables aseptic processing, allowing for rapid production of individual batches without the risk of cross-contamination, and eliminates the need for cleaning and sterilization steps in between batches. NANOme is highly adaptable for clinical use in personalized medicines such as therapeutic cancer vaccines and as an adjunct to platforms for CAR-T.
Want to learn more?
Our team will be happy to tell you more, contact us.