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Formulation

UST leverages its many decades of formulation development, processing, and cryopreservation expertise to protect, stabilize, and deliver biomacromolecules, membranes, viruses, bacteria, enzymes, mammalian cells and multicellular specimens.  See UST's fact sheet to learn more about the breadth of our applications and services.

 

 By working closely with its partners to help them develop superior biological products, UST is able to apply its proprietary stabilization and delivery technologies on a diverse range of applications.  

 

Select examples:

 

Vaccines

 

We have demonstrated long-term ambient temperature stability (including at 37°C and higher temperatures) for extended periods of time for a variety of vaccines including many live attenuated vaccines (LAVs) in the dry state such as:

 

  • mRNA, DNA, Small pox, Yellow Fever, Measles, Rubella, Rabies, RSV, Influenza, Shigella, Salmonella, Cholera, Listeria, Sterne Strain Anthrax, and Polio OPV

 

Microbes

 

We have demonstrated a shelf life measured in years and for many months at or above 37°C for various microorganisms including those found in soil, plants, rumen, and humans.  We have deep expertise and help our partners develop shelf stable products for agriculture, animal health & nutrition, and human microbiome (e.g. live biotherapeutic products). Select examples include:

  • L. acidophilus, L. rhamnosus, L. reuteri, L. jensenii, L. crispatus, B. lactis, E.coli, S. epidermidis, pichia kudriavzevii, K. variicola, and many others which are stable at high ambient temperatures in the dry state.

 

Other Macromolecules

 

We have also developed thermostable enzymes, growth factors, therapeutic proteins, and other molecular items at 40°C and with minimal to no activity losses after drying and subsequent storage.  Our formulation process allows delivery of biologics in powder format for mucosal and/or transdermal delivery with proprietary delivery devices. 

 

Our Approach

 

Our approach to the stabilization of biologicals in the dry state at ambient temperatures is based on the following facts and working hypotheses:

 

  • Effective long-term preservation of biologicals at ambient temperatures (AT) requires immobilization of intracellular macromolecules (proteins, DNA, RNA, etc.) as well as cellular membranes in dry carbohydrate glass below its glass transition temperature Tg.  The glass transition temperature is the temperature at which the solution transitions from liquid to glass or from mobile to fixed. 

 

  • Dehydration may not be a direct damaging factor to biological structure and function.  Some of the dehydration-induced damage to unprotected biologicals is associated with hydration forces that rise between biological membranes and macromolecules when the distance between them becomes very small. This dehydration-induced damage can be diminished by replacing a portion of the water of hydration before drying with protective carbohydrates (fillers) that replace the water and adsorb to the surface of the biological membranes and macromolecules.  The fillers protect in two ways: they eliminate hydration forces and they also create glassy shells around the biological membranes or macromolecules.  Thus, some minimum amount of intracellular filler should be delivered to or present in cells to insure cell survival during drying and subsequent storage at AT. 
     

  • Dr. Bronshtein was the first scientist to demonstrate that in order to achieve stability of biologicals (e.g. proteins), when stored at room or higher temperatures, the concentration of sugars has to be significantly higher than that required to achieve stability at 0°C.

 

  • To preserve biologicals at ambient temperature, one must use protective fillers (for example sugars and amino acids) with high Tg (e.g., above room temperature) in the anhydrous state.  Fillers also should not belong to highly reactive chemicals like glucose and other reducing monosaccharides.    

 

To learn more about the formulation of delivery devices with VitriLife® drop us a message below or click here.

 

 

CONTACT US 

Universal Stabilization Technologies, Inc.

4050 Sorrento Valley Blvd, Ste. L

San Diego, CA 92121

Tel: 858-625-2896 

Fax: 858-625-2897

info@vitrilife.com

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