Method for preparing a diafiltered stabilized blood product
First Claim
1. A method of preparing a stabilized cellular blood product by diafiltering a starting material to produce a cellular retentate and a filtrate, the method comprising diafiltering the starting material against at least one exchange of a buffer, wherein the starting material comprises whole blood or a blood product, the cellular retentate comprises a diafiltered stabilized cellular blood product, and the filtrate comprises contaminating plasma proteins.
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Abstract
A method using diafiltration to prepare a blood product is described. The method removes contaminating plasma proteins from whole blood or blood products. Diafiltration may be used on paraformaldehyde-fixed platelets to remove formaldehyde to undetectable levels, and to suspend the platelets into a formulation buffer suitable for subsequent treatment, such as lyophilization. The manufacturing procedure can be divided into three steps, a first diafiltration, fixation, preferably with paraformaldehyde, and a second diafiltration. In the first step, plasma proteins are removed from fresh or stored platelets or blood cells. The technique is gentle to prevent the activation and aggregation of the platelets. Fixation stabilizes the platelets to withstand freezing, lyophilization and subsequent reconstitution, and also provides a viral and bacterial reduction. The second diafiltration removes the paraformaldehyde to undetectable levels, and suspends the platelets or blood cells into a formulation buffer for subsequent lyophilization.
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Citations
20 Claims
- 1. A method of preparing a stabilized cellular blood product by diafiltering a starting material to produce a cellular retentate and a filtrate, the method comprising diafiltering the starting material against at least one exchange of a buffer, wherein the starting material comprises whole blood or a blood product, the cellular retentate comprises a diafiltered stabilized cellular blood product, and the filtrate comprises contaminating plasma proteins.
- 4. A method of preparing a stabilized blood product by diafiltering a starting material to produce a retentate and a filtrate, the method comprising diafiltering the starting material against at least one exchange of a buffer, wherein the starting material comprises platelet-rich plasma or platelet concentrate, the retentate comprises a diafiltered stabilized blood product, and the filtrate comprises contaminating plasma proteins.
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9. A method of preparing a stabilized blood product by diafiltering a starting material to produce a cellular retentate and a filtrate, the method comprising:
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diafiltering the starting material against at least one exchange of a buffer, wherein the starting material comprises whole blood or a blood product, the cellular retentate comprises a diafiltered blood product, and the filtrate comprises contaminating plasma proteins; and stabilizing the cellular retentate. - View Dependent Claims (10, 11)
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Specification