QbD-guided pharmaceutical development of Pembrolizumab biosimilar candidate PSG-024 propelled to industry meeting primary requirements of comparability to Keytruda®

Author:

Jaffar-Aghaei MortezaORCID,Khanipour FarzadORCID,Maghsoudi Amir,Sarvestani Rahim,Mohammadian Mahdi,Maleki Maryam,Havasi Forugh,Rahmani Hossein,Karagah Amir-Hossein,Kazemali Mohammad-Reza

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference65 articles.

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3. High-level expression of full-length antibodies using trans-complementing expression vectors;Bianchi;Biotechnol. Bioeng.,2003

4. Business Wire, 2021. Merck provides update on KEYTRUDA® pembrolizumab indication in third line gastric cancer in the US. https://www.businesswire.com/news/home/20210701005834/en/Merck-Provides-Update-on-KEYTRUDA%C2%AE-pembrolizumab-Indication-in-Third-Line-Gastric-Cancer-in-the-US. (Accessed 22 November 2021).

5. Separation of Monoclonal Antibodies By Analytical Size Exclusion Chromatography;Chakrabarti,2018

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