	US 12,351,620 B1
	Process for production of a soluble and insoluble collagen product from mammalian dermis tissue
Mohammad Z. Albanna, Chandler, AZ (US); and Nilabh S. Kajave, Tempe, AZ (US)
Assigned to Humabiologics, Inc., Phoenix, AZ (US)
Filed by Humabiologics, Inc., Phoenix, AZ (US)
Filed on Nov. 3, 2024, as Appl. No. 18/935,623.
Application 18/935,623 is a continuation in part of application No. 18/654,723, filed on May 3, 2024, granted, now 12,134,792.
Claims priority of provisional application 63/463,579, filed on May 3, 2023.
Int. Cl. C09H 3/02 (2006.01); A61K 38/39 (2006.01); A61K 47/42 (2017.01); C07K 14/78 (2006.01); C11B 1/10 (2006.01); C12N 9/26 (2006.01)

CPC C07K 14/78 (2013.01) [C12N 9/2414 (2013.01); C12Y 302/01001 (2013.01)]

3 Claims

1. A process for the methacrylation of a soluble collagen from an extracted collagen from mammalian dermis tissue comprising:

a) providing said extracted collagen including said soluble collagen and an insoluble collagen;

b) salt precipitation of the soluble collagen to isolate a type I soluble collagen and further comprising methacrylation of the type I soluble collagen, comprising:

c) providing a methacrylic anhydride solution:

d) combining the type I soluble collagen with an acid to produce a type I soluble collagen solution;

wherein the molarity of acid is between 0.005 M to 5 M;

e) adding base to the type I soluble collagen solution to produce a non-pH adjusted collagen solution;

f) providing buffer and adding said buffer to the non-pH adjusted collagen solution to adjust the pH between 7.0 and 8.0, producing a pH adjusted type I soluble collagen solution;

g) adding the methacrylic anhydride solution to the pH adjusted type I soluble collagen solution to produce a type I soluble collagen methacrylic anhydride solution:

h) agitating the type I soluble collagen methacrylic anhydride solution for a methacrylation time of at least 2 hours at a temperature between 0° C. to 20° C.;

i) centrifuging the type I soluble collagen methacrylic anhydride solution from step (h) to collect supernatant containing type I soluble collagen methacrylate; and

j) dialyzing the supernatant containing type I soluble collagen methacrylate against acid for at least 1 day to produce methacrylated type I soluble collagen:

k) lyophilization of the methacrylated soluble type I collagen comprising freezing the methacrylated soluble type I collagen and then heating the frozen methacrylated soluble type I collagen to a lyophilization temperature of at least 10° C. (50° F.) while drawing vacuum on the methacrylated soluble type I collagen, wherein a vacuum pressure is at least 100 mTorr:

wherein a degree of methacrylation of the methacrylated type I soluble collagen produced is between 10% to 95%.