Characterization of protein aggregating tungstates: electrospray mass spectrometry analysis of extracts from prefilled syringes and from tungsten pins used in the …

M Ronk, H Lee, K Fujimori, P Yeh… - PDA Journal of …, 2016 - journal.pda.org
Glass prefilled syringes are increasingly becoming a container of choice for storing and
administering therapeutic protein products to patients. Tungsten leaching from a PFS is …

Root cause analysis of tungsten-induced protein aggregation in pre-filled syringes

W Liu, R Swift, G Torraca… - PDA Journal of …, 2010 - journal.pda.org
Particles isolated from a pre-filled syringe containing a protein-based solution were
identified as aggregated protein and tungsten. The origin of the tungsten was traced to the …

Development of an inductively coupled plasma mass spectrometry method for quantification of extracted tungsten from glass prefilled syringes used as a primary …

K Fujimori, H Lee, J Phillips… - PDA Journal of …, 2013 - journal.pda.org
Leachable tungsten is associated with protein aggregation and precipitation in glass
prefilled syringes, and this may trigger immunogenicity concerns. Determining the level of …

Tungsten‐induced protein aggregation: Solution behavior

Y Jiang, Y Nashed‐Samuel, C Li, W Liu… - Journal of …, 2009 - Wiley Online Library
Tungsten has been associated with protein aggregation in prefilled syringes (PFSs). This
study probed the relationship between PFSs, tungsten, visible particles, and protein …

Fragmentation of a monoclonal antibody by peroxotungstate

H Rathnayaka, O Mozziconacci, A Sreedhara… - Pharmaceutical …, 2018 - Springer
Purpose Tungsten and tungsten oxide leachates found in glass pre-filled syringes were
identified to initiate protein precipitation and aggregation. Here, we tested the possibility of …

Precipitation of a monoclonal antibody by soluble tungsten

JS Bee, SA Nelson, E Freund, JF Carpenter… - Journal of …, 2009 - Elsevier
Tungsten microparticles may be introduced into some pre-filled syringes during the creation
of the needle hole. In turn, these microcontaminants may interact with protein therapeutics to …

Study of tungstate–protein interaction in human serum by LC–ICP-MS and MALDI-TOF

N Rodríguez-Fariñas, MM Gomez-Gomez… - Analytical and …, 2008 - Springer
Oral administration of sodium tungstate is an effective treatment for type 1 and 2 diabetes in
animal models; it does not incur significant side effects, and it may constitute an alternative …

Validation of an inductively coupled plasma-mass spectrometry method to quantify tungsten in human plasma. Determination of percentage binding to plasma proteins

S Le Lamer-Déchamps, P Poucheret, JL Pérez… - Clinica chimica acta, 2003 - Elsevier
Background: The aim of this paper was to validate an inductively coupled plasma-mass
spectrometry (ICP-MS) method to quantify tungsten in human plasma and to study its …

[HTML][HTML] Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity

A Seidl, O Hainzl, M Richter, R Fischer, S Böhm… - Pharmaceutical …, 2012 - Springer
Purpose Following two cases of neutralizing antibodies to epoetin alfa in an investigational
clinical study, a small number of individual syringes of two drug product batches were found …

Electrospray mass spectrometry of aqueous solutions of isopolyoxotungstates

DK Walanda, RC Burns, GA Lawrance… - Journal of Cluster …, 2000 - Springer
Electrospray mass spectrometry (ESMS) has been conducted on aqueous solutions of
isopolyoxotungstate systems. There is direct evidence that the desorption process in the …