Characterization of submicron (0.1-1 μm) particles in therapeutic proteins by nanoparticle tracking analysis

Journal of Pharmaceutical Sciences
Rekha VasudevNataliya Afonina

Abstract

The importance of 0.1-1 μm submicron particles characterization in therapeutic proteins, which was limited because of a lack of suitable methods, has been recognized recently. An application of nanoparticle tracking analysis (NTA) for characterization of 18 lots of recombinant fusion protein (rP1) drug product presentation along with stressed samples of this material exposed to heat at 50°C, agitation, and UV light was studied. In addition, monodisperse polystyrene standards with nominal sizes of 60-800 nm and rP1 samples spiked with 100-400 nm polystyrene standards were analyzed. The NTA technique was capable of demonstrating good sizing of monodisperse polystyrene standards, detect small particle size population in 800 nm standard, and resolve three size populations in the mixture of four standards (60-400 nm). The NTA was also capable of resolving 400 nm polystyrene standard from the main rP1 peak, but was not able to resolve 100 and 200 um standards because of the particle distribution profiles overlap. A characterization of 0.1-1 μm submicron particles in rP1 showed a relatively diverse range of mean particle diameters, D90, and size distributions, which was not linked to the lots storage duration prior to analysis. The si...Continue Reading

References

Aug 26, 1999·International Journal of Pharmaceutics·W Wang
Jul 18, 2002·Nature Reviews. Drug Discovery·Huub Schellekens
Dec 4, 2003·Biochemistry·Filip Meersman, Karel Heremans
Feb 2, 2008·Journal of Pharmaceutical Sciences·Sylvia KieseHanns-Christian Mahler
Aug 16, 2008·Journal of Pharmaceutical Sciences·John F CarpenterBarry Cherney
Mar 24, 2010·Journal of Pharmaceutical Sciences·Satish K SinghThomas Spitznagel
Apr 2, 2011·The Journal of Biological Chemistry·Marisa K JoubertLinda O Narhi
Dec 14, 2011·Journal of Pharmaceutical Sciences·Sarah ZöllsAndrea Hawe
Apr 3, 2012·Pharmaceutical Research·Vasco FilipeWim Jiskoot
Aug 23, 2012·Journal of Pharmaceutical Sciences·Andrea HaweWim Jiskoot
Mar 7, 2013·Journal of Pharmaceutical Sciences·Sarah ZöllsAndrea Hawe

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.