Structural similarity, characterization of Poly Ethylene Glycol linkage and identification of product related variants in biosimilar pegfilgrastim.

Structural similarity, characterization of Poly Ethylene Glycol linkage and identification of product related variants in biosimilar pegfilgrastim.

The approval of biosimilars requires demonstration of biosimilarity, which rests on the base of thorough analytical characterization of the biosimilar product. In addition to demonstration of biosimilarity, the product related impurities need to be thoroughly characterized and controlled at minimal...

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Main Authors: Rakesh Shekhawat, Chintan Kumar Shah, Akash Patel, Sankaranarayanan Srinivasan, Poonam Kapoor, Suvaskumar Patel, Sharwan Kumar, Sandeep Sonar, Namrata More, Manasvi Joshi, Jatin Patel, Milan Vachhani, Bhargav Prasad Kodaganti, Upasana Choavatiya, Arabhi Pushpaja, Shubhangi Argade, Nidhi Nuwal, Manish Kumar, Sridevi Khambhampaty
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2019-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0212622

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https://doi.org/10.1371/journal.pone.0212622

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