Performance Period: 7/1/2019 to 6/30/2021
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 a novel dehydration technology (Microglassification™) that will enable preservation of biologics at multiple points in downstream purification, eliminating process flow interruptions and allowing quick response to changing demand. By producing dehydrated DS, storage volumes will be significantly reduced, and the biologic will be less sensitive to temperature fluctuations.
This project will evaluate technical and commercial practicability of using this process for bulk DS preservation by:
1) comparing Microglassified™ and spray dried enzyme formulations,
2) investigating the stability of mAb Microglassified™ from CHO cell culture and a purified formulation,
3) investigating the stability of scFv Microglassified™ from E. Coli and a purified formulation, and
4) performing a risk and cost analysis of scale-up.
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.
Microglassification™ is compatible with a continuous-processing environment.
Addresses the industry’s growing need for storage of large-volume production of bulk drug substance or bioreactor harvest.
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Lindy Biosciences, Inc.
Genentech
North Carolina State University
