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Clinical

Manufacturing

Must provide “substantial evidence” of product’s safety and efficacy in humans.
Clinical Studies are Grouped into Three Phases:
The first step is to file an Investigational New Drug (IND) application which is supported by the data from the Pre-Clinical Phase. Studies performed under an IND are often classified into phases as if they are separate and distinct steps in the process. In reality, the phases overlap and trials in one phase are often conducted simultaneously with trials in other phases. Clinical studies are grouped according to their objective into three types or phases:

 

Phase I Clinical Development (Human Pharmacology) – Thirty days after a biopharmaceutical company has filed its IND, it may begin a small-scale Phase I clinical trial unless the FDA places a hold on the study. Phase I studies are used to evaluate pharmacokinetic parameters and tolerance, generally in healthy volunteers.  These studies include initial single-dose studies, dose escalation, and short-term repeated-dose studies.

Phase II Clinical Development (Therapeutic Exploratory) – Phase II clinical studies are small-scale trials to evaluate a drug’s preliminary efficacy and side-effect profile in 100 to 250 patients.  Additional safety and clinical pharmacology studies are also included in this category.

Phase III Clinical Development (Therapeutic Confirmatory) – Phase III studies are large-scale clinical trials for safety and efficacy in large patient populations. While phase III studies are in progress, preparations are made for submitting the Biologics License Application (BLA) or the New Drug Application (NDA).  BLAs are currently reviewed by the FDA’s Center for Biologics Evaluation and Research (CBER).  NDAs are reviewed by the Center for Drug Evaluation and Research (CDER).

 

The biological activity of nanoparticles can be influenced by the manufacturing process.


Clinical Manufacturing Solutions

Scalable manufacturing is a significant challenge to making revolutionary nanomedicines available to patients in need. PNI’s Clinical Solutions Team provides a complete clinical manufacturing solution for nanomedicines. Our Scale-Up System technology is modular, customizable and services include analytical services and CMC support. Additionally, our expertise and services include license & supply agreements, site audits, and CMO partnerships. Precision NanoSystems provides complementary technology and over 100 years of combined scientific expertise.


Scale-Up System

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To learn how Precision NanoSystems accelerates nanomedicine development from an idea to clinical applications, contact our Technical Sales Team.

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Resource Center

Publication - Abstract

November 29, 2018

International Journal of Pharmaceutics

Rapid and scale-independent microfluidic manufacture of liposomes entrapping protein incorporating in-line purification and at-lin...

N. Forbes, MT. Hussain, ML. Briuglia, DY. Edwards, JH. terHorst, N. Szita, Y. Perrie

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Poster

July 01, 2018

Robust low-volume production of nanoparticles for genetic manipulation of cells

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Application Note

July 01, 2018

Seamless scale up of liposomal verteporfin formulations using the NanoAssemblr® Platform

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Publication - Abstract

April 26, 2018

Small Methods

State‐of‐the‐Art Design and Rapid‐Mixing Production Techniques of Lipid Nanoparticles for Nucleic Acid Delivery

Evers, M. J. W., Kulkarni, J. A., van der Meel, R., Cullis, P. R., Vader, P., & Schiffelers, R. M.

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Publication - Abstract

February 27, 2018

Cell Reports

A Single Administration of CRISPR/Cas9 Lipid Nanoparticles Achieves Robust and Persistent In Vivo Genome Editing

J. Finn, A. Smith, M. Patel, L. Shaw, M. Youniss, J. Heteren, T. Dirstine, C. Ciullo, R. Lescarbeau, J. Seitzer, R. Shah...

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Publication - Abstract

November 29, 2018

Carbohydrate Polymers

N-oxy lipid-based click chemistry for orthogonal coupling of mannan onto nanoliposomes prepared by microfluidic mixing...

E. Bartheldyová, et al.

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Resource Center

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