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.
By implementing Microglassification™, an organization could reduce frozen bulk storage volume by approximately 95%, enabling higher storage temperatures (2–8 °C), significant energy and cost savings, improved workflow and process control, and compatibility with continuous processing.
Demonstrated stability of a Microglassified™ mAb and a Microglassified™ scFv
Published two scale-up cost and risk analysis reports: Microglassification(TM) Scale-up Cost and Risk Analysis Report Bulk Drug Substance Preservation of Biologics: Challenges, Complexities, Costs & Commentary
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
Bitterfield, D. & Jones, N., Novel Dehydration Technology to Streamline Drug Substance Processing and Preservation, NCBIO Biotech Manufacturers Forum, March 4, 2020.
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
