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The Clinical Solutions Team is ready for your transformative drug candidates.
Contact UsClinical Solutions
An integrated suite of proprietary technology, custom services, and nanomedicine expertise to empower our clients to create transformative medicines that significantly improve human well being.
An integrated suite of products, services
We can help develop and optimize your nanoparticle’s physicochemical properties and biological activity. Let us help you identify critical quality attributes and draft drug product specifications. Our team can also help develop custom analytical methods for your nanoparticle formulations and raw materials.
The Blaze System is next used either at PNI or installed at your site to develop and establish the process parameters for preparing your nanoparticle formulations. This development work is performed at an intermediate scale, to conserve your valuable therapeutic agents. We can also assist with optimizing the downstream processing steps of your products, such as Tangential Flow Filtration (TFF) and Sterile Filtration.
Process Translation to GMP System
The Clinical Solutions team can configure a GMP NanoAssemblr® System to meet your requirements. Formulations are translated from the Blaze to the GMP System confirming equivalency with demonstration batches. We can also assist with preparing and testing batches to support GLP-Tox studies.
Technology Transfer to GMP Drug Product Facility
We can help you transfer equipment, materials and analytical methods to your GMP manufacturing site along with the required documentation. We can also assist with the Qualification of the GMP NanoAssemblr® System, provide on-site training and prepare product-specific GMP Master Batch Records.
CMC Support for GMP Manufacturing
PNI can support your Chemistry Manufacturing & Controls (CMC) needs by providing oversight for the manufacture and testing of your Engineering & GMP batches.
The Clinical Solutions Team is ready for your transformative drug candidates.
Contact UsEvery customer and project is unique, requiring a tailored approach with an eye for quality and efficiency. We pride ourselves on our ability to bring our collective knowledge and expertise in Quality Management to all of our partners. PNI has developed a Quality Management System (QMS) that aligns with the requirements of 21 CFR Parts 210 and 211 such that PNI’s customers receive Scale-Up system components that are in full compliance for cGMP manufacturing.
To learn how Precision NanoSystems accelerates nanomedicine development from an idea to clinical applications, contact our Technical Sales Team.
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