CERSI Collaborators: University of Maryland, Baltimore and College Park: Bruce Yu, PhD, Marc Taraban, PhD

FDA Collaborators: James Coburn, MS; Kirstie Snodderly, MEng; Ashwinkumar Bhirde, PhD, Weiming Ouyang, PhD

Project Start: January 27, 2023

Regulatory Science Challenge

Current drug product assessment techniques require product content to either be removed from its container or directly in contact with the container. For some methods, there are additional, and sometimes complex, preparation steps too. There is a need for new process analytical technologies that can analyze drug products in their original containers (such as a vial, prefilled syringe, or injection pen) without such constraints, particularly in resource limited settings. This project addresses that need.

Specifically, it explores a measurement technology called water proton Nuclear Magnetic Resonance (wNMR) which is capable of quantitatively assessing the consistency and variability, including outlier detection, of drug products presented in vials, syringes, and injection pens without compromising the integrity of the drug products. wNMR also shows promise because data collection is quick (seconds to minutes), automatable, and the instrument is relatively small (fits on a tabletop).

It also has the potential to enable robust tracking of product quality throughout the supply chain and long-term storage of products. Since drug products can be analyzed in their containers and wNMR does not harm or destroy products, the measured products can be safely delivered for use by patients after a quantitative measurement is performed.

The technology explored in this project quantitatively and noninvasively evaluates drug products and is being assessed for the potential adoption in the pharmaceutical industry. If adopted, this technology could save time and resources by providing feedback to manufacturers about the manufacturing process and ultimate quality of products. Adoption of this technology could improve manufacturing processes and drug product quality through more tightly controlled processes and enhanced surveillance of product quality, and, in some cases, improve patient safety.

Project Description and Goals

The overall goal of this project is to evaluate the wNMR technology as a potential product inspection technology with three major aims:

1. Compare brand name and biosimilar products to explore wNMR as a method to assess how tightly controlled the manufacturing process is between very similar products made by different manufacturers.
2. Compare vials and syringes of the same suspension product, which naturally settle under the forces of gravity, to test of the capability of wNMR to assess the consistency of suspension products.
3. Evaluate powder vaccine product, which needs to be mixed with a water solution (diluent) before injection (a process called reconstitution), to test the capability of wNMR to assess manufacturing control of the product itself by measuring both before and after adding the diluent; and to assess the usefulness of wNMR for stability monitoring in the real-world by measuring the stability of product after reconstitution.