Effect of polysorbate 80 quality on photostability of a monoclonal antibody.

AAPS PharmSciTech
Swita R SinghArvind Srivastava

Abstract

Polysorbate 80 is one of the key components of protein formulations. It primarily inhibits interfacial damage of the protein molecule due to mechanical stress during shipping and handling. However, polysorbate 80 also affects the formulation photostability. Exposure to light of polysorbate 80 aqueous solution results in peroxide generation, which in turn may result in oxidation of the susceptible amino acid residues in the protein molecule. The purpose of this study was to determine if the photostability of our proprietary IgG(1) monoclonal antibody formulation containing polysorbate 80 is affected by the quality (grade/vendor) of polysorbate 80. Following four types of polysorbate 80 were tested: (1) Polysorbate 80 Super-Refined, Mallinckrodt Baker, (2) Polysorbate 80 NF, Mallinckrodt Baker, (3) Polysorbate 80 NF, EMD Chemicals, and (4) Ultra-pure Polysorbate 80 (HX), NOF Corporation. The samples were exposed to light as per ICH guidelines Q1B. The results of the study show that photostability of the antibody formulation is indeed affected by the quality of polysorbate 80. This study underscores the importance of carefully choosing the quality of polysorbate 80 to ensure the robustness of formulation.

References

Dec 1, 1978·Journal of Pharmaceutical Sciences·M DonbrowA Pillersdorf
Nov 1, 1991·Pharmaceutical Research·B M EckhardtT A Bewley
Aug 1, 1989·Chemical & Pharmaceutical Bulletin·K SasaokiK Nishi
Feb 1, 1986·Archives of Biochemistry and Biophysics·A L Frelinger, J E Zull
Aug 1, 1970·The Journal of Pharmacy and Pharmacology·K C James, R H Leach
Jan 1, 1984·Current Eye Research·L I Grossweiner
Jun 1, 1995·Journal of Pharmaceutical Sciences·M KatakamA K Banga
Jul 1, 1994·Journal of Biochemical and Biophysical Methods·J JaegerS P Wolff
Dec 1, 1996·Journal of Pharmaceutical Sciences·B S ChangJ F Carpenter
Dec 31, 1997·Journal of Pharmaceutical Sciences·X M LamJ L Cleland
Oct 31, 2001·Journal of Photochemistry and Photobiology. B, Biology·M J Davies, R J Truscott
Sep 13, 2002·Journal of Pharmaceutical Sciences·Emily HaY John Wang
Oct 1, 1961·The Journal of Pharmacy and Pharmacology·L V COATESK TATTERSALL
May 24, 2006·Journal of Chromatography. a·Damian HoudeYelena Lyubarskaya
Jan 19, 2007·Journal of Pharmaceutical Sciences·Bruce A Kerwin, Richard L Remmele
Feb 2, 2008·Journal of Pharmaceutical Sciences·Sylvia KieseHanns-Christian Mahler
Dec 17, 2008·Current Pharmaceutical Biotechnology·J Vlasak, R Ionescu
Feb 10, 2010·Pharmaceutical Research·Mark Cornell ManningDerrick S Katayama

❮ Previous
Next ❯

Citations

May 18, 2013·International Journal of Pharmaceutics·Ravinder Malik, Ipsita Roy
Nov 16, 2012·AAPS PharmSciTech·Meera AgarkhedArvind Srivastava
Dec 18, 2013·Journal of Pharmaceutical Sciences·Yilma T AdemOsigwe Esue
Mar 14, 2014·Journal of Pharmaceutical Sciences·Wei WangSantosh V Thakkar
Dec 29, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Alavattam SreedharaRavuri S K Kishore
Jun 15, 2014·International Journal of Pharmaceutics·Edoardo LongoGiuliano Siligardi
Dec 17, 2014·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Alexandra C BraunLorenz Meinel
Feb 18, 2015·New Biotechnology·F A Gutiérrez-MejíaM W J Prins
May 31, 2016·Journal of Pharmaceutical Sciences·Weiqiang ChengMark Yang
Mar 8, 2018·MAbs·Alexandre AmbrogellyHongcheng Liu
Aug 5, 2017·AAPS PharmSciTech·Meera AgarkhedArvind Srivastava
Jun 26, 2020·PloS One·Yelena Ionova, Leslie Wilson
May 19, 2019·Pharmaceutical Research·Geoffrey A HeinzlV Ashutosh Rao
May 24, 2020·Antioxidants·Ema Valentina BrovčJanez Mravljak
Oct 10, 2020·Journal of Pharmaceutical Sciences·Andrea AllmendingerKathrin Abstiens
Feb 19, 2021·Critical Reviews in Biotechnology·Harleen Kaur
Apr 5, 2021·Journal of Pharmaceutical Sciences·Arvind SrivastavaGer Brophy
Aug 30, 2019·Journal of Pharmaceutical Sciences·Yoann Le BasleValérie Sautou
May 23, 2021·International Journal of Pharmaceutics·Wolfgang KaiserPatrick Garidel
Jul 13, 2018·Molecular Pharmaceutics·Aaron J CourtenayRyan F Donnelly

❮ 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.