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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

Solution

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.

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Project Lead

Lindy Biosciences, Inc.

Lindy Biosciences, Inc.

Participating Organizations

Genentech

Genentech

North Carolina State University

North Carolina State University