To further support our clients and ensure project success, Phosphorex has partnered with technology providers to offer state- of-the-art microfluidic equipment & systems in our labs. Phosphorex’s scientists are using microfluidic systems to fabricate numerous types of lipidic and polymeric nanoparticle systems. Use of microfluidic systems provides many advantages over conventional particle fabrication techniques including tight control of particle size, tunability, process control, and seamless scale-up.
Phosphorex developed a road map for systematic, rational process of nanoparticle (NP) formulation development, utilizing design of experiments:
‒ Step 1. Formulation screening at small-scale At this stage, we test lipid or polymeric compositions, varying ratio of components and cargo.
‒ Step 2. Development At this stage, our scientists start establishing scalable unit operations and optimize formulation for optimal shelf stability.
‒ Step 3. Scale- up Our team will scale up to meet the needs of both pre-clinical and clinical development.
Phosphorex has expertise in encapsulating a range of APIs in the nanoparticle systems: from small molecules to proteins/peptides and nucleic acids.
Analytical methodology is developed to direct formulation development and optimization and includes:
‒ Dynamic light scattering (DLS) for particle size characterization ‒ HPLC for API quantitation (Shimadzu and Waters), including CAD, ELSD detectors for lipid quantitation ‒ Fluorescent microplate reader for nucleic acid quantitation
We offer the following systems:
The NanoAssemblr® Ignite+™
Expand Preclinical Capabilities and Simplify Scale-Up
Ignite+ expands the capabilities of Ignite with increased total flow rates of up to 200 mL/min pre-dilution and volumes of up to 60 mL. This enables larger preclinical and early process development studies at the bench scale and simplifies scale-up by maintaining the same CPPs as the NanoAssemblr Blaze and GMP System. Using the NxGen 500 microfluidic mixer which is also used in larger systems ensures consistent CQAs as you transition to clinical development and manufacturing while maintaining the easy-to-use, low-volume workflow of Ignite.
The NanoAssemblr® Blaze™
An End-to-End Process
The success of a new drug program requires a scalable process. NxGen technology delivers a scalable means to perform the critical particle formation step in the nanomedicine development process. Using the NanoAssemblr Blaze with NxGen technology, process development can be conducted on both the upstream and downstream portions— from material preparation to buffer exchange, filtering and analytics—to ensure that a program is ready to quickly accelerate to the clinic.
ANP System
A unique, comprehensive and flexible single system for both process optimization and continuous production.
The Automated Nanoparticle (ANP) System speeds up and automates your process development, and initial production of larger samples of lipid nanoparticle with a select number of promising formulations while decreasing consumption of costly reagents.
The versatile, high throughput ANP System offers excellent monodispersity and encapsulation efficiency, which improves experimental consistency. The ease of set-up and modification of parameters allows for reduced optimization timeframes, making it suitable for automated process development.
