Format

Send to

Choose Destination
PLoS One. 2017 Jul 31;12(7):e0181251. doi: 10.1371/journal.pone.0181251. eCollection 2017.

High-resolution physicochemical characterization of different intravenous immunoglobulin products.

Author information

1
Research, Momenta Pharmaceuticals, Cambridge, Massachusetts, United States of America.
2
Research, CDI Laboratories, Baltimore, Maryland, United States of America.
3
Research, CDI Laboratories, Mayaguez, Puerto Rico.

Abstract

Intravenous immunoglobulin (IVIg) is a complex mixture drug comprising diverse immunoglobulins and non-IgG proteins purified from the plasma of thousands of healthy donors. Approved IVIg products on the market differ regarding source of plasma, isolation process, and formulation. These products are used widely, and often interchangeably, for the treatment of immunodeficiency and autoimmune and inflammatory diseases, but their mechanisms of action in different indications are not well understood. A primary limitation to understanding the therapeutic relevance of specific components within IVIg has been the limited resolution of analytics historically implemented to characterize its complex mixture. In this study, high-resolution analytics were applied to better understand the composition of IVIg and product variations. We characterized three approved IVIg products: Gammagard®, Privigen®, and Octagam®. Differences in the distribution of molecular weight species, IgG sequence variants, isoforms, glycoforms, and the repertoire of previously reported antibody specificities were identified. We also compared the effect of aging on these products to identify changes in size distribution and posttranslational modifications. This type of characterization may provide insights into the specific factors and components of IVIg that may influence its activity and ultimately lead to optimization of IVIg products for use in autoimmune diseases.

PMID:
28759653
PMCID:
PMC5536303
DOI:
10.1371/journal.pone.0181251
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Public Library of Science Icon for PubMed Central
Loading ...
Support Center