开始
欲了解 Precision NanoSystems 如何加速从创意到临床应用的纳米药物研发过程,请联系我们的技术销售团队。
取得联系临床解决方案
一整套将产品、服务和专业知识相结合的一体化解决方案,帮助客户创造可显著改善人类福祉的革命性药物。
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.
Every 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.
Dedicated Team to Support Your Commercialization Needs
Precision NanoSystems has strategically placed global team members who specialize in nanomedicine development, microfluidics and instrument engineering to provide the critical bridge from clinical effectiveness to a commercially viable brand. At Precision NanoSystems, clinical and commercial disciplines work together, sharing insights and knowledge.
She received her
Dr. Jeffs brings 20 years of experience in the Biotechnology industry working Lipid-based drug delivery systems. He has expertise in formulation and process development and has played key roles in the Technology Transfer and GMP manufacture of RNA-based Lipid Nanoparticles to support multiple
He received a
Poster
September 01, 2022
Application Note
March 15, 2022
Publication - Abstract
July 01, 2020
Journal of Controlled Release
Publication - Abstract
May 08, 2020
Vaccines
Publication - Abstract
April 02, 2020
Journal of Controlled Release