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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Detalles Bibliográficos
Autores principales: Shekhawat, Rakesh, Shah, Chintan Kumar, Patel, Akash, Srinivasan, Sankaranarayanan, Kapoor, Poonam, Patel, Suvaskumar, Kumar, Sharwan, Sonar, Sandeep, More, Namrata, Joshi, Manasvi, Patel, Jatin, Vachhani, Milan, Kodaganti, Bhargav Prasad, Choavatiya, Upasana, Pushpaja, Arabhi, Argade, Shubhangi, Nuwal, Nidhi, Kumar, Manish, Khambhampaty, Sridevi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2019
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6415886/
https://www.ncbi.nlm.nih.gov/pubmed/30865643
http://dx.doi.org/10.1371/journal.pone.0212622

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