University of Nebraska Medical Center

Standard Protocols, Templates and Forms

Our GLP and cGMP facilities strive to maintain the highest quality standards for the synthesis, characterization, and quality controls for all products we produce.

To these ends, protocols were assembled that reflect step-wise processes from pre-clinical design to GLP testing followed by sequential cGMP production. The available protocols are our standard laboratory methods beginning with cell isolation and cultivation to formulation, preparation, and characterization. Animal studies describing detailed pharmacokinetic, pharmacodynamic, and toxicological assessments are available under "model systems" and "templates and forms".

These protocols facilitate rigor and reproducibility of all methods that we employ and are instrumental in the development of formulation optimization in the GLP pre-production facility. Scale-up for final products deployed for IND (investigational new drug)-enabling studies are performed in our cGMP facility.