Author:
Costantino Henry R.,Culley Heather,Chen Lishan,Morris Daniel,Houston Michael,Roth Sharin,Phoenix Mary Jo,Foerder Chuck,Philo John S.,Arakawa Tsutomu,Eidenschink Lisa,Andersen Niels H.,Brandt Gordon,Quay Steven C.
Reference36 articles.
1. Characterizing biological products and assessing comparability following manufacturing changes;Chirino;Nat Biotechnol,2004
2. Biophysical comparability of the same protein from different manufacturers: A case study using Epoetin alfa from Epogen and Eprex;Deechongkit;J Pharm Sci,2006
3. Galson SK.2006. FDA response to citizen's petition Docket nos. 2004P-023 11CP1 and SUP 1,2003P-0 1 76lCP 1 and EMC 1, 2004P-0171lCP1, and 2004N-0355, letter dated 30 May.http://www.fda.gov/ohrms/dockets/dockets/04P0231/04P-0231-pdn0001.pdf.
4. Effect of protein aggregates: An immunological perspective;Rosenberg;AAPS J,2006
5. A risk-based approach to immunogenicity concerns of therapeutic protein products, Part 1: Considering consequences of the immune response to a protein;Rosenberg;Biopharm Int,2004
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