Developability Assessments of Monoclonal Antibody Candidates to Minimize Aggregation During Large-Scale Ultrafiltration and Diafiltration (UF-DF) Processing

Author:

Whitaker Neal,Pace Samantha E.,Merritt Kimberly,Tadros MadeleineORCID,Khossravi Mehrnaz,Deshmukh SmeetORCID,Cheng Yuan,Joshi Sangeeta B.,Volkin David B.ORCID,Dhar PrajnaparamitaORCID

Funder

Bristol-Myers Squibb

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference33 articles.

1. Immunogenicity challenges associated with subcutaneous delivery of therapeutic proteins;Jarvi;BioDrugs,2021

2. Physicochemical stability of monoclonal antibodies: a review;Le Basle;J Pharm Sci,2020

3. Strategies for high-concentration drug substance manufacturing to facilitate subcutaneous administration: a review;Holstein;Biotechnol Bioeng,2020

4. Subcutaneous delivery of high-dose/volume biologics: current status and prospect for future advancements;Badkar;Drug Des Devel Ther,2021

5. Ongoing challenges to develop high concentration monoclonal antibody-based formulations for subcutaneous administration: Quo Vadis?;Jiskoot;J Pharm Sci,2021

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