Devices for Aseptic Lyophilization of Biological Samples


Biological materials are often lyophilized and stored in small aliquots for long-term preservation as a means of improving stability and expanding shelf life. At present, sterility of solutions cannot be preserved throughout the lyophilization process, and reconstituted samples must be filtered to remove contaminants such as fungi or bacteria, resulting in considerable loss of expensive sample via absorption by the filter. Thus, there exists a need for a device that eliminates microbial contamination throughout the lyophilization process and provides materials that are ready to use following lyophilization.

This technology offers a functional method to prevent microbial contamination during lyophilization and a simple means to prevent contamination. It affords a convenient system for gas venting and exchange utilizing a microcentrifuge tube fitted with a cap incorporating a filter membrane. In a related technology, a unique, cost-effective multi-well plate assembly provides for simultaneous lyophilization of small sample volumes for high-throughput operations. Thus, these technologies are well-suited for researchers concerned about contamination during the lyophilization process. Given the spillage often occurring within centrifugal freeze-dryers, these technologies are also useful even when sterility is not needed, as they prevent contamination from the often-dirty interiors of laboratory centrifugal freeze-dryers, as well as cross-contamination between samples undergoing lyophilization. In addition, by extending shelf-lives, these technologies enable researchers to purchase expensive biomolecules and pharmaceuticals in money-saving bulk quantities. Furthermore, these technologies permit cells to be grown and stored axenically, in small quantities, with or without lyophilization.

Potential Commercial Applications: Competitive Advantages:
  • Maximizes the shelf-lives of expensive biomolecules and pharmaceuticals.
  • Makes practical the bulk purchase of expensive biomolecules and pharmaceuticals by extending shelf-lives.
  • Makes possible the axenic storage of cells via aseptic freeze-drying.
  • Makes possible the production and use of small, sterile aliquots of precious materials by eliminating unnecessary filtration steps.
  • Makes possible the sterile growth of cells in small volumes.
 


Development Stage:
Development is complete and invention has been successfully tested.

Inventors:

Geoffrey Kidd (NEI)  ➽ more inventions...


Intellectual Property:
U.S. Pat: 5,958,778 issued 1999-09-28
U.S. Pat: 6,503,455 issued 2003-01-07
US Application No. 09/303,785
US Application No. 10/238,147

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Admin. Licensing Specialist (ALS),
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OTT Reference No: E-015-1995/2
Updated: Sep 1, 2006