# US 10,946,046 B2 · Method for sterilising a platelet lysate

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- Number: US 10,946,046 B2
- Document ID: US10946046B2
- Status: Granted
- Kind: B2
- Application number: 15/577,993
- Filed: 2016-05-27
- Published: 2018-10-11
- Granted: 2021-03-16
- Earliest claimed: 2015-05-29
- Assignees: Maco Pharma
- Applicants: Maco Pharma
- Inventors: Bruno Delorme; Sabrina Viau; Francis Goudaliez
- Web page: https://patentgrep.com/patent/US10946046B2

## CPC

- A61K 35/19: Platelets; Megacaryocytes
- A61L 2/081: Gamma radiation
- C12N 5/0644: {Platelets; Megakaryocytes}
- C12N 5/0662: {Stem cells}
- A61L 2103/05: Living organisms or biological materials
- C12N 2500/84: from mammals
- C12N 2501/115: Basic fibroblast growth factor (bFGF, FGF-2)
- C12N 2529/00: Culture process characterised by the use of electromagnetic stimulation
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A method for sterilising a platelet lysate in the liquid state comprising at least the endogenous growth factors TGF-beta 1, EGF, PDGF-AB, IGF-1, VEGF and bFGF. The method comprising freezing the liquid platelet lysate in order to obtain a frozen platelet lysate, and irradiating the frozen platelet lysate with ionising radiation in order to obtain a sterilised platelet lysate, the irradiation being adapted so as to preserve at least 80% of the concentration of at least one of the endogenous growth factors chosen from the group consisting of TGF-beta 1, EGF, PDGF-AB, IGF-1 and VEGF.

## Claims

### Claim 1

A method for sterilizing a platelet lysate comprising:
a. providing a liquid platelet lysate with a platelet preservative solution;
b. freezing said liquid platelet lysate in order to obtain a frozen platelet lysate;
c. irradiating said frozen platelet lysate in a non freeze-dried state with gamma radiation at an absorbed dose within the range from 35-60 kGy to obtain a sterilized platelet lysate, said irradiation being adapted so as to preserve at least 80% of the concentration of at least one of the endogenous growth factors chosen from the group consisting of TGF-beta1, EGF, PDGF-AB, IGF-1, and VEGF.

### Claim 2 (depends on 1)

The method of claim 1, wherein the liquid platelet lysate is created from a platelet suspension.

### Claim 3 (depends on 2)

The method of claim 2, wherein the creation of the liquid platelet lysate from platelet suspension comprises:
a. subjecting the platelet suspension to at least one freezing/thawing cycle so as to obtain a lysate platelet composition;
b. separating said lysed platelet composition into a clear platelet lysate fraction and a cellular debris fraction; and
c. isolating said platelet lysate fraction in the liquid step to create a liquid platelet lysate.

### Claim 4 (depends on 2)

The method of claim 2, wherein said platelet suspension comprises platelets suspended in plasma.

### Claim 5 (depends on 1)

The method according to claim 1, further comprising a step of filtering the platelet lysate in the liquid state through a filter of 0.22 to 0.65 μm.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the freezing of the liquid platelet lysate is carried out at a temperature of approximately −80° C.

### Claim 7

A method for sterilizing a platelet lysate comprising:
a. adding a platelet preservative solution to a platelet suspension;
b. subjecting the platelet suspension to at least one freezing/thawing cycle so as to obtain a lysate platelet composition
c. separating said lysed platelet composition into a clear platelet lysate fraction and a cellular debris fraction; and
d. isolating said platelet lysate fraction in the liquid step to create a liquid platelet lysate
e. freezing said liquid platelet lysate in order to obtain a frozen platelet lysate;
f. irradiating said frozen platelet lysate in a non freeze-dried state with gamma radiation at an absorbed dose within the range from 35-60 kGy to obtain a sterilized platelet lysate, said irradiation being adapted so as to preserve at least 80% of the concentration of at least one of the endogenous growth factors chosen from the group consisting of TGF-beta1, EGF, PDGF-AB, IGF-1, and VEGF.