|United States Patent||8,013,022|
|DeAngelo , et al.||September 6, 2011|
Disclosed is a multi-compartment medical device useful in the storage, processing and extended shelf life of perishable products, especially pharmaceutical, food and biological products. Particular biological materials processed according to the present methods are human blood and blood products (RBCs). Also disclosed are processes for preserving food, pharmaceutical and biological products for long-term storage and extended shelf life employing a process that reduces the hydration level of the material to less than native hydration levels of the specific product. The invention further provides stabilized biological products, such as in the form of glassified beads, prepared using a two-phase system according to the described processes that may be rehydrated and prepared for clinical use, and having essentially no loss of biological and/or pharmacological activity.
|Inventors:||DeAngelo; Joseph (Carrboro, NC), Needham; David (Durham, NC), Jones; Carroll (Coronado, CA)|
|Filed:||April 27, 2007|
|Current U.S. Class:||514/772 ; 424/455; 424/489; 424/94.1; 424/94.2; 435/307.1; 514/13.4; 514/15.2; 514/832; 514/833; 514/938; 514/939; 516/21; 516/22; 516/54; 516/923|
|Current International Class:||B01F 3/08 (20060101); A61K 38/41 (20060101); C12M 1/00 (20060101)|
|Field of Search:||435/307.1 424/93.7,94.1,94.2,455 514/13.4,15.2,832,833,938,939,941 516/54,923,21,22|
|5438041||August 1995||Zheng et al.|
|5935588||August 1999||Afriat et al.|
Okochi et al, Preparation and evaluation of w/o/w type emulsions containing vancomycin, Advanced Drug Delivery Reviews, 45, 5-26, 2000. cited by examiner .
Merrill et al. (1932), Journal of General Physiology, pp. 243-256. cited by other .
Carpenter and Crowe (1998), Crybiology. 25(5): 459-470. cited by other .
Zaks and Klibanov (1998), Journal of Biological Chemistry, (1998), 263 (7): 3194-3201. cited by other .
Khmelnitsky et al. (1991), European Journal of Biochemistry, 198 (1): 31-41. cited by other .
McMinn et al. (1993), Biopolymers, 33: 1213-1224. cited by other .
Scopes, (1994), "Separation by Precipitation", Chapter 4 from Protein Purification: Principles and Practice, pp. 71-101. cited by other .
Griebenow et al. (1996), J. Am. Chem. Soc., 118(47): 11695-11700. cited by other .
Tao Ke, et al. (1998), Biotechnology and Bioengineering, 57 (6): 746-750. cited by other .
Partridge et al. (1998), Biotechnology and Bioengineering, 57 (6): 746-750. cited by other .
Dai et al. (1998), Chem. Commun., pp. 841-842. cited by other .
Tanabe et al. (2000), Biosci. Biotechnol. Biochem., 64(9): 2005-2007. cited by other .
Klibanov et al. (2001), Nature, 409: 241-246. cited by other .
Vladimir et al. (2001), Biochimica st Biophysica Acta, 1547 (2): 359-369. cited by other.