Modeling and prediction of excipient and pH drifts during ultrafiltration/diafiltration of monoclonal antibody biotherapeutic for high concentration formulations

Author:

Hebbi Vishwanath,Roy Souhardya,Rathore Anurag S.,Shukla Anupam

Funder

Department of Biotechnology, Government of India

Publisher

Elsevier BV

Subject

Filtration and Separation,Analytical Chemistry

Reference19 articles.

1. Biopharmaceutical benchmarks 2014;Walsh;Nat. Biotech.,2014

2. D.M. Ecker, S.D. Jones, H.L. Levine, The Therapeutic Monoclonal Antibody Market. In: MAbs, Taylor & Francis, 2015, pp. 9–14.

3. Therapeutic monoclonal antibodies and derivatives: historical perspectives and future directions;Rodgers;Biotechnol. Adv.,2016

4. Formulation and manufacturability of biologics;Shire;Curr. Opin. Biotechnol.,2009

5. E. De Cock, P. Kritikou, S. Tao, C. Wiesner, T. Waterboer, A. Carella, Time savings with Rituximab subcutaneous injection versus intravenous infusion: Final analysis from a time-and-motion study in 8 different countries, Blood: Nov, 15 (2013) 21.

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