Inspecting Insulin Products Using Water Proton NMR. I. Noninvasive vs Invasive Inspection.

ABSTRACT:

Background

There is a clear need to transition from batch-level to vial/syringe/pen-level quality control of biologic drugs, such as insulin. This could be achieved only by noninvasive and quantitative inspection technologies that maintain the integrity of the drug product.

Methods

Four insulin products for patient self-injection presented as prefilled pens have been noninvasively and quantitatively inspected using the water proton NMR technology. The inspection output is the water proton relaxation rate R₂(¹H₂O), a continuous numerical variable rather than binary pass/fail.

Results

Ten pens of each product were inspected. R₂(¹H₂O) displays insignificant variation among the 10 pens of each

SUBMITTER: Taraban MB 

PROVIDER: S-EPMC9631543 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature