Impact of extractables/leachables from filters on stability of protein formulations
Abstract
Aqueous extractables/leachables from three sterilizing-grade filter membranes [polyvinylidene fluoride (PVDF), polyethersulfone (PES), and mixed cellulose ester (MCE)] were found to significantly reduce the surface tension of aqueous solutions. To evaluate the effect of these extractables/leachables from filter membranes on stability of protein formulations, model IgG2 formulations (with or without added surfactant) were spiked with different levels of filter extractables from stock solutions as a stress study. The stock solutions of extractables were created by processing the filter membranes through autoclaving and soaking steps. The IgG2 formulations were subsequently subject to agitation and temperature stress. Extractables/leachables from the filters were found to have a significant protective (PVDF, PES) and destabilizing (MCE) impact on both visible and subvisible particulates formation under agitation stress for formulations that did not contain any additional surfactant such as polysorbate 80. The impact of filter extractables/leachables on chemical stability of the antibody formulation displayed a more complicated pattern, but was generally destabilizing, causing increases in aggregation, oxidation, and acidic species. In conclusion, extractables/leachables from filter membranes may have impact on protein formulation stability and caution should be exercised during protein filtration, especially when filtering small volumes and in preformulation or high-throughput s…
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Materials like PES, HPPE, UHMWPE, and PVDF are commonly used due to their exceptional chemical resistance, thermal stability, and low permeability.
“Materials like polyethersulfone (PES), polyethylene (high-performance polyethylene (HPPE), ultra-high molecular weight polyethylene (UHMWPE)), and polyvinylidene fluoride (PVDF) are commonly used due to their exceptional chemical resistance, thermal stability, and low permeability.”
From Single-use solutions for PUPSIT: requirements, challenges, and solutions (2026) · cites this paper as Huang, et al. 2011
Other materials such as PEEK, PP, and silicone also play important roles, with PEEK providing excellent mechanical and thermal properties for high-performance connectors and housings, and silicone offering flexibility and biocompatibility, though it requires thorough evaluation for extractables.
“Other materials such as polyether ether ketone (PEEK), polypropylene (PP), and silicone also play important roles, with PEEK providing excellent mechanical and thermal properties for high-performance connectors and housings, and silicone offering flexibility and biocompatibility, though it requires thorough evaluation for extractables (Kushwah, et al. 2022; Huang, et al. 2011; Jenke et al. 2006).”
From Single-use solutions for PUPSIT: requirements, challenges, and solutions (2026) · cites this paper as Huang, et al. 2011
These materials retain mechanical strength and microbial barrier function even after gamma irradiation, making them ideal for sterile filtration systems.
“These materials retain their mechanical strength and microbial barrier function even after gamma irradiation, making them ideal for sterile filtration systems.”
From Single-use solutions for PUPSIT: requirements, challenges, and solutions (2026) · cites this paper as Huang, et al. 2011
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Single-use solutions for PUPSIT: requirements, challenges, and solutions
Glenz, M., Eiermann, P., Manser, B., & Teschner, H. (2026) · Applied Microbiology and Biotechnology · doi:10.1007/s00253-026-13847-5 · Cited by 1 · see citing works
- Authors
- Huang, M., Horwitz, T. S., Zweiben, C., & Singh, S. K.
- Venue
- Journal of Pharmaceutical Sciences
- Publisher
- Elsevier BV
- Published
- 2011-11
- Volume
- 100
- Issue
- 11
- Pages
- 4617-4630
- ISSN
- 0022-3549
- Cited by
- 40
- References
- 0
- Language
- en
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