US 12,226,532 B2
Coated biological composition
Timothy Ganey, Tampa, FL (US); and Tracy Scott Anderson, Atlanta, GA (US)
Assigned to VIVEX BIOLOGICS GROUP, INC., Atlanta, GA (US)
Filed by Vivex Biologics Group, Inc., Atlanta, GA (US)
Filed on Oct. 16, 2020, as Appl. No. 17/072,625.
Application 17/072,625 is a division of application No. 15/898,558, filed on Feb. 17, 2018.
Application 15/591,513 is a division of application No. 14/683,221, filed on Apr. 10, 2015, granted, now 9,675,643, issued on Jun. 13, 2017.
Application 15/590,444 is a division of application No. 14/682,523, filed on Apr. 9, 2015, granted, now 9,687,511, issued on Jun. 27, 2017.
Application 15/590,475 is a division of application No. 14/682,523, filed on Apr. 9, 2015, granted, now 9,687,511, issued on Jun. 27, 2017.
Application 15/898,558 is a continuation in part of application No. 15/837,694, filed on Dec. 11, 2017, granted, now 11,160,904.
Application 15/837,694 is a continuation in part of application No. 15/591,513, filed on May 10, 2017, granted, now 10,513,690, issued on Dec. 24, 2019.
Application 15/837,694 is a continuation in part of application No. 15/590,444, filed on May 9, 2017, abandoned.
Application 15/591,513 is a continuation in part of application No. 15/590,475, filed on May 9, 2017, granted, now 10,760,058, issued on Sep. 1, 2020.
Application 15/898,558 is a continuation in part of application No. 15/591,513, filed on May 10, 2017, granted, now 10,513,690, issued on Dec. 24, 2019.
Application 15/898,558 is a continuation in part of application No. 15/590,444, filed on May 9, 2017, abandoned.
Application 15/898,558 is a continuation in part of application No. 15/590,475, filed on May 9, 2017, granted, now 10,760,058, issued on Sep. 1, 2020.
Claims priority of provisional application 62/129,351, filed on Mar. 6, 2015.
Claims priority of provisional application 62/129,337, filed on Mar. 6, 2015.
Prior Publication US 2021/0030688 A1, Feb. 4, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 35/12 (2015.01); A61K 9/50 (2006.01); A61K 9/51 (2006.01); A61L 27/36 (2006.01); A61L 27/38 (2006.01); C12N 5/0775 (2010.01); C07C 31/22 (2006.01); C07C 317/04 (2006.01); C07H 3/04 (2006.01); C09D 177/04 (2006.01)
CPC A61K 9/5031 (2013.01) [A61K 9/5123 (2013.01); A61L 27/3608 (2013.01); A61L 27/3804 (2013.01); C12N 5/0663 (2013.01); A61L 2430/38 (2013.01); C07C 31/225 (2013.01); C07C 317/04 (2013.01); C07H 3/04 (2013.01); C09D 177/04 (2013.01)] 43 Claims
 
1. A method of making a coated biological composition comprising the steps of:
(a) grinding a cut vertebral body to produce a mixture comprising crushed vertebral bone and bone marrow, wherein the cut vertebral body is obtained from a cadaver donor;
(b) mechanically separating cellular and non-cellular components of the bone marrow from the vertebral bone in the mixture by tumbling and sieving the vertebral bone from a decanted fluid of the bone marrow comprising the cellular components comprising whole cells, and non-whole cellular components comprising non-whole cell components;
(c) concentrating the decanted fluid by centrifugation;
(d) filtering the decanted fluid through a blood filter to form a mixture including the cellular and non-whole cellular components and remove any remaining vertebral bone;
(e) separating the cellular components comprising whole cells and non-whole cellular components of the bone marrow directly from the mixture of step (d) by density gradient centrifugation, wherein the separation under centrifugation establishes a cell density gradient;
(e) collecting non-cellular fractions or non-cellular components or combinations-thereof of predetermined density from the gradient;
(f) washing the non-cellular fractions or non-cellular components or combinations thereof to create a mixture;
(g) suspending the mixture of step (f) to a predetermined concentration in a liquid protectant to form the coated biological composition;
(h) freezing the coated biological composition at a predetermined controlled rate; and
(i) thawing and freezing the coated biological composition a second time prior to storage;
(ii) thawing and refrigerating the coated biological composition;
(iii) thawing and concentrating the coated biological composition by drying; or
(iv) lyophilizing the frozen coated biological composition for ambient or room temperature storage.