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.

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.

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.

PNI can support your Chemistry Manufacturing & Controls (CMC) needs by providing oversight for the manufacture and testing of your Engineering & GMP batches.