Satisfying QTPP of Erythropoietin Biosimilar by QbD through DoE-Derived Downstream Process Engineering

Satisfying QTPP of Erythropoietin Biosimilar by QbD through DoE-Derived Downstream Process Engineering

Well-characterized and scalable downstream processes for the purification of biologics are extremely demanding for delivering quality therapeutics to patients at a reasonable price. Erythropoietin (EPO) is a blockbuster biologic with diverse clinical applications, but its application is limited to f...

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Bibliographic Details
Main Authors: Kakon Nag, Enamul Haq Sarker, Samir Kumar, Sourav Chakraborty, Maksusdur Rahman Khan, Mashfiqur Rahman Chowdhury, Rony Roy, Ratan Roy, Bipul Kumar Biswas, Emrul Hasan Bappi, Mohammad Mohiuddin, Naznin Sultana
Format: Article
Language:English
Published: MDPI AG 2023-08-01
Series:Pharmaceutics
Subjects:
erythropoietin
biosimilar
critical process parameter (CPP)
design of experiment (DoE)
purification
quality by design (QbD)
Online Access:https://www.mdpi.com/1999-4923/15/8/2087

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https://www.mdpi.com/1999-4923/15/8/2087

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