From Federal Register, late Nov. 1996

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Container for Drying Biological Samples, Method of Making Such Container, and Method of Using Same

Problem Addressed By This Invention:
Many compounds, such as drugs, growth factors, etc., must be kept sterile and must be aliquotted for storage. Usually, these aliquots are best stored lyophilized. Yet, researchers have never had a way to keep aliquots sterile through the lyophilization process. Consequently, each aliquot has had to be filter-sterilized when reconstituted for use. This process has the disadvantages of consuming excessive filters, syringes, sterile, receptacles, and time and results in serious loss of precious sample due to absorption by the filters (especially with small aliquots less than 1 ml). Alternatively, researchers have had to forego lyophilization and store their solutions in the less-stable frozen form.

Solution Offered By This Invention:
Sterile-lyophilization tubes having a 0.22 micron filter built into the cap. This unique feature allows a sterile solution to remain sterile throughout lyophilization, even after the vacuum is released and air reenters the tube. Thus, a starting solution is simply filter-sterilized while in a relatively large volume, using a single filter and therefore suffering minimal loss and consuming little time. It is then aliquotted into sterile-lyophilization tubes and lyophilized. The tubes can then be transferred directly to the freezer, if desired. The compound is reconstituted when needed, and may then be used immediately without further filtration.

Potential Applications Of This Invention:
All researchers worldwide who utilize sterile, labile compounds will have an interest in this product, including governmental, university, institutional, and drug company laboratories. Most notably in need are investigators involved in drug-testing, which is normally done either in cell cultures, laboratory animals, or humans, and which requires sterility of many aliquots of many drugs. Additionally, this product will have a large market relating to basic research utilizing microbial, plant, or animal cell or organ cultures, to which sterile compounds such as growth factors are commonly added. Research in drugs, growth factors, etc., is expanding ever more rapidly, and generally requires a cell culture system in which to study such compounds. Most of these compounds are quite expensive. Loss of potency during storage and loss of material during filtration are widespread problems which may be overcome with this invention. Therefore, there exists a tremendous need, and immense market for, this sterile-lyophilization vessel.

Stage Of Development:
Development is complete and invention has been successfully tested. Prototypes are available.

Inventor:
GL Kidd (NEI)

Patent Status:
Serial No. 08/717,114 filed 20 Sep 96 (claiming priority date of 22 Sep 95)

Portfolio:
Devices/Instrumentation - Research Tools and Materials, devices

For additional information, please contact:
David Sadowski
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, MD 20852-3804
Phone: 301/496-7735 ext 288
Fax: 301/402-0220