More efficient preservation methods for bulk drug substance (DS) must be developed to accommodate the increasing use of biologics. Current preservation methods are costly, not easily scaled and require storage at ultra-low temperatures.
Lindy Biosciences is developing Microglassification™, a dehydration technology that preserves biologics during downstream purification, reduces storage volumes, and makes biologics less sensitive to temperature changes, allowing for quick response to demand changes.
Reduce frozen bulk storage volume by ~95% and eliminate the need for long-term storage at temperatures below -20°C, possibly allowing storage at 2-8°C or higher.
Addresses the industry’s growing need for storage of large-volume production of bulk drug substance or bioreactor harvest.
Microglassification™ is compatible with a continuous-processing environment.
Bitterfield, D. & Jones, N., Novel Dehydration Technology to Streamline Drug Substance Processing and Preservation, NCBIO Biotech Manufacturers Forum, March 4, 2020.
Chandrababu, K. B., Kannan, A., Savage, J. R., Stadmiller, S., Ryle, A. E., Cheung, C., Kelley, R. F., Maa, Y., Saggu, M., & Bitterfield, D. L. (2024). Stability Comparison Between Microglassification and Lyophilization Using a Monoclonal Antibody. Journal of Pharmaceutical Sciences, 113(4), 1054-1060. https://doi.org/10.1016/j.xphs.2023.10.021
Novel Dehydration Technology to Streamline Drug Substance Processing and Preservation (BioCAD) (PC1.0-037), NIIMBL Member Forum, Virtual, September 24, 2020.
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Lindy Biosciences, Inc.
Genentech, Inc.
North Carolina State University
