Impact of Stainless Steel Exposure on the Oxidation of Polysorbate 80 in Histidine Placebo and Active Monoclonal Antibody Formulation

Ganapathy Gopalrathnam; Anant Navanithan Sharma; Steven Witt Dodd; Lihua Huang

doi:10.5731/pdajpst.2017.008284

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Impact of Stainless Steel Exposure on the Oxidation of Polysorbate 80 in Histidine Placebo and Active Monoclonal Antibody Formulation

Ganapathy Gopalrathnam, Anant Navanithan Sharma, Steven Witt Dodd and Lihua Huang

PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 163-175; DOI: https://doi.org/10.5731/pdajpst.2017.008284

Ganapathy Gopalrathnam

1Bioproduct Pharma Design

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For correspondence: gopalrathnam_ganapathy@lilly.com

Anant Navanithan Sharma

1Bioproduct Pharma Design

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Steven Witt Dodd

1Bioproduct Pharma Design

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Lihua Huang

2Protein Characterization, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

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vol. 72 no. 2 163-175

DOI

https://doi.org/10.5731/pdajpst.2017.008284

PubMed

29343621

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Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

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Published online March 23, 2018.

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Ganapathy Gopalrathnam1,*,
Anant Navanithan Sharma1,
Steven Witt Dodd1 and
Lihua Huang2

¹Bioproduct Pharma Design
²Protein Characterization, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

↵* Corresponding Author: Bioproduct Pharma Design, Lilly Research Laboratories, Eli Lilly and Company, 1400 West Raymond Street, Indianapolis, IN 46221. Telephone: 317-277-0109; e-mail: gopalrathnam_ganapathy{at}lilly.com

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Impact of Stainless Steel Exposure on the Oxidation of Polysorbate 80 in Histidine Placebo and Active Monoclonal Antibody Formulation

Ganapathy Gopalrathnam, Anant Navanithan Sharma, Steven Witt Dodd, Lihua Huang

PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 163-175; DOI: 10.5731/pdajpst.2017.008284

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Impact of Stainless Steel Exposure on the Oxidation of Polysorbate 80 in Histidine Placebo and Active Monoclonal Antibody Formulation

Ganapathy Gopalrathnam, Anant Navanithan Sharma, Steven Witt Dodd, Lihua Huang

PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 163-175; DOI: 10.5731/pdajpst.2017.008284

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A Mechanistic Understanding of Polysorbate 80 Oxidation in Histidine and Citrate Buffer Systems--Part 2

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Keywords

Polysorbate 80
Polysorbate 20
histidine
metal ion
stainless steel
Oleic acid
Lauric acid
Citrate
oxidation
monoclonal antibody

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