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Pre-Clinical
Only a small percentage of the thousands of compounds tested during the discovery phase possess the desired activity and are now designated as “hits”.
Pre-clinical Formulation Approaches
A handful of the most promising hits are chosen for modification to improve target specificity, potency, chemical and metabolic stability, water solubility, and other pharmacological parameters
Before anything is given to humans, safety and efficacy tests are conducted using computerized models, cells, and animals. The NanoAssemblr® Blaze was developed to bridge the gap between nanoparticle discovery and clinical development.
The development of an overall formulation strategy to support in vivo studies should be considered carefully as it can reduce cycle time and resources. This strategy must be comprehensive, encompassing early studies designed to identify and validate drug targets, to long-term toxicology studies and ultimately, to support clinical studies in humans.
Pre-Clinical Phase Solutions
During the Pre-Clinical stage, the NanoAssemblr® Ignite manufactures
1 – 15 mL of nanomedicine per run for continued optimization, preliminary stability studies and in vivo testing in small models.
The dynamic volume range allows researchers to use the Blaze for in vivo studies in larger models, preclinical toxicology testing, early Chemistry, Manufacturing and Controls (CMC) studies and downstream process development.
Our services will provide you with a formulation and a technology transfer into a production facility that you can be confident will be suitable for clinical scale-up. PNI offers highly qualified scientist through our Formulation Solutions Team.
Resource Center
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