Technologies and Applications Toward Preservation of Cells in a Dry State for Therapies
1Sana Biotechnology, Inc., South San Francisco, California, USA.
Abstract:
Cell-based therapeutics promise to transform the treatment of a wide range of diseases, many of which, up to this point, are incurable. During the past decade, an increasing number of cell therapies have been approved by government regulatory agencies in the United States, Europe, and Japan. Thousands of clinical trials based on live cell therapies are now taking place around the world. But most of these live cell therapies face temporal and/or spatial distances between manufacture and administration, posing a risk of degradation in potency. Cryopreservation has become the predominant biobanking approach to maintain the product's safety and efficacy during transportation and storage. However, the necessity of cryogenic shipment and storage could limit patient access to these emerging therapies and increase the costs of logistics. In the (bio)pharmaceutical industries, freeze-drying and desiccation are established preservation procedures for manufacturing small molecule drugs, liposomes, and monoclonal antibodies. Over the past two decades, there has been a growing body of research exploring the freeze-drying or drying of mammalian cells, with varying degrees of success. This article provides an overview of the technologies that were adopted or developed in these pioneering studies, paving the road toward the preservation of cell-based therapeutics in a dry state for biomanufacturing.
Insights
Researchers are exploring dry-state preservation for cell-based therapeutics to overcome limitations of cryopreservation. This approach aims to improve accessibility and reduce costs for these life-changing treatments.
Area of Science:
- Biotechnology
- Regenerative Medicine
- Pharmaceutical Sciences
Background:
- Cell-based therapeutics offer novel treatment options for incurable diseases.
- Approved cell therapies are increasing, with numerous clinical trials globally.
- Current cryopreservation methods for cell therapies face challenges in transport and storage, impacting potency and accessibility.
Purpose of the Study:
- To review technologies for preserving cell-based therapeutics in a dry state.
- To address the limitations of cryopreservation in cell therapy logistics.
- To explore advancements in biomanufacturing for stable cell therapies.
Main Methods:
- Overview of established drying technologies (freeze-drying, desiccation) in the pharmaceutical industry.
- Review of research exploring dry-state preservation of mammalian cells over the past two decades.
- Analysis of technologies adopted or developed in pioneering studies for cell preservation.
Main Results:
- Established drying techniques are successfully used for small molecules, liposomes, and antibodies.
- Research into drying mammalian cells has shown varying degrees of success.
- Pioneering studies have developed and adopted specific technologies for dry-state preservation.
Conclusions:
- Dry-state preservation offers a promising alternative to cryopreservation for cell-based therapeutics.
- Advancements in drying technologies could enhance the stability, accessibility, and cost-effectiveness of cell therapies.
- This review highlights key technologies enabling the biomanufacturing of preserved cell-based therapeutics.
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