Development of isoporous microslit silicon nitride membranes for sterile filtration applications. Issue 3 (18th December 2019)

• Record Type: Journal Article
• Authors: Wright, Evan; Miller, Joshua J.; Csordas, Matthew; Gosselin, Andrew R.; Carter, Jared A.; McGrath, James L; Latulippe, David R.; Roussie, James A.
• Is Part Of: Biotechnology and bioengineering. Volume 117:Issue 3(2020)
• Page Start: 879
• Page End: 885
• Publication Date: 2019-12-18
• Subjects: biological therapeutics -- silicon nanomembranes -- sterile filtration; Biotechnology -- Periodicals; Bioengineering -- Periodicals; 660.6
• DOI: 10.1002/bit.27240
• Languages: English
• ISSNs: 0006-3592

Abstract

Abstract: The widely used 0.2/0.22 µm polymer sterile filters were developed for small molecule and protein sterile filtration but are not well‐suited for the production of large nonprotein biological therapeutics, resulting in significant yield loss and production cost increases. Here, we report on the development of membranes with isoporous sub‐0.2 μm rectangular prism pores using silicon micromachining to produce microslit silicon nitride (MSN) membranes. The very high porosity (~33%) and ultrathin (200 nm) nature of the 0.2 µm MSN membranes results in a dramatically different structure than the traditional 0.2/0.22 µm polymer sterile filter, which yielded comparable performance properties (including gas and hydraulic permeance, maximum differential pressure tolerance, nanoparticle sieving/fouling behavior). The results from bacteria retention tests, conducted according to the guidance of regulatory agencies, demonstrated that the 0.2 µm MSN membranes can be effectively used as sterile filters. It is anticipated that the results and technologies presented in this study will find future utility in the production of non‐protein biological therapeutics and in other biological and biomedical applications. Abstract : Membranes with isoporous sub‐0.2 μm rectangular prism pores were developed using silicon micromachining. The very high porosity (~33%) and ultrathin (200 nm) nature of the 0.2 µm microslit silicon nitride (MSN) membranes are dramatically different than the traditional 0.2/0.22 µm polymer sterile filter. Bacteria retention tests, conducted according to the guidance of regulatory agencies, demonstrated that the 0.2 µm MSN membranes can be effectively used as sterile filters.