NOTICE: Due to a lapse in annual appropriations, most of this website is not being updated. Learn more.
Form submissions will still be accepted but will not receive responses at this time. Sections of this site for programs using non-appropriated funds (such as NVLAP) or those that are excepted from the shutdown (such as CHIPS and NVD) will continue to be updated.
An official website of the United States government
Here’s how you know
Official websites use .gov
A .gov website belongs to an official government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.
Detection of Residual Enzymatic Activity in Plant-Derived Recombinant Human Serum Albumin Products Using 31P NMR Spectroscopy
Published
Author(s)
Robert G Brinson, John P. Marino, Zvi Kelman, Gary Giulian
Abstract
The minimization of impurities in biotherapeutics, such as host cell proteins (HCPs) and other molecules, is critical due to potential toxicity and/or immunogenic responses to foreign-sourced molecules in the human body. Currently, the ELISA assay, due to its high sensitivity and dynamic range, is the standard for detection of residual HCP contamination in recombinantly-produced biologics from bacterial, yeast, or mammalian expression systems1. Alternatively, two-dimensional liquid chromatography coupled to mass spectrometry (2D-LCMS) is being developed as a tool for assessing this critical quality attribute2, 3. Both methods rely on the direct detection of HCPs. In the case of HCP enzymes, the mass level of contamination may fall below the threshold of detection using these methods and underestimate the true nature of the contamination. To address this point, here we demonstrate a sensitive, label-free nuclear magnetic resonance spectroscopy
, R.
, Marino, J.
, Kelman, Z.
and Giulian, G.
(2014),
Detection of Residual Enzymatic Activity in Plant-Derived Recombinant Human Serum Albumin Products Using 31P NMR Spectroscopy, Analytical Chemistry, [online], https://doi.org/10.1021/ac503864m
(Accessed October 8, 2025)