Journal
BIOTECHNOLOGY AND BIOENGINEERING
Volume 117, Issue 3, Pages 879-885Publisher
WILEY
DOI: 10.1002/bit.27240
Keywords
biological therapeutics; silicon nanomembranes; sterile filtration
Categories
Funding
- National Institutes of Health [1R43-GM128475-01]
- National Science Foundation [NNCI-1542081]
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The widely used 0.2/0.22 mu m 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 mu m 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 mu m MSN membranes results in a dramatically different structure than the traditional 0.2/0.22 mu m 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 mu m 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.
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