Novel Dehydration Technology to Streamline Drug Substance Processing and Preservation
Lindy Biosciences is developing a novel dehydration technology (Microglassification™) that will enable preservation of biologics during downstream purification.
Categories
Proteins/ Antibodies
Drug product
Project status
100% Completed
Industry Need
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.
Solution
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.
Outputs/Deliverables
Demonstrated stability of a Microglassified™mAb
Demonstrated stability of 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
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