Water loss from silicone tubing and effect on protein concentration during drug product manufacturing

Author:

Ranadive Pinaki,Bedi SoniaORCID,Bhalla Amardeep S.,Shameem Mohammed

Funder

Regeneron Pharmaceuticals Inc

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference15 articles.

1. Science and art of protein formulation development;Wang;Int. J. Pharm.,2019

2. M. Vázquez-Rey, D. A. Lang, Aggregates in monoclonal antibody manufacturing processes, Biotechnol. Bioeng. 108 (2011) 7. https://doi.org/10.1002/bit.23155.

3. Synergistic effects of flow and interfaces on antibody aggregation;Grigolato;Biotechnol. Bioeng.,2020

4. S. Bedi, M. P. Hwang, Y. Zhao, Y. Mao, A. S. Bhalla, N. Li, M. Shameem, Container Materials for Biopharmaceuticals: A comparative small-scale case study of stainless steel and a proprietary nickel-based alloy. Bioprocess Int. (2022). https://bioprocessintl.com/manufacturing/single-use/container-materials-for-biopharmaceuticals-a-comparative-small-scale-case-study-of-stainless-steel-and-a-proprietary-nickel-based-alloy/.

5. Aggregation and particle formation of therapeutic proteins in contact with a novel fluoropolymer surface versus siliconized surfaces: effects of agitation in vials and in prefilled syringes;Teska;J. Pharm. Sci.,2016

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