Allogeneic human plasma and platelet derived products and uses thereof
Inventors
Alshamleh, Ehab Mosa • Bennett, Barbara • Fu, Karen • Hall, Andrew James • Patil, Vishwesh Ashok • Schmitke, Jennifer Louise • Wright, Teresa Leah • Newman, Jennifer • Grier, William Kane
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12576109-B2
Publication Date
2026-03-17
Expiration Date
Abstract
Provided herein are compositions comprising allogeneic human plasma and platelet derived product, and methods for making the compositions and using the compositions as a therapeutic for example, in orthopedic indications.
Core Innovation
The invention relates to an allogeneic human plasma and platelet derived product in which cells and cell debris are removed. The product comprises human plasma proteins including human serum albumin, immunoglobulins, and fibrinogen, and human platelet proteins including platelet derived growth factor (PDGF)-AB. The resulting pharmaceutical composition contains a defined total protein concentration greater than 50 mg/mL and less than or about 500 mg/mL.
The core process concept combines platelet protein extraction with multiple extraction methods, including at least two of freeze-thaw, buffer-detergent, osmotic pressure, sonication, electroporation, and microfluidics using platelet passage through microchannels at high pressure. The description further includes downstream purification and clarification to remove cell debris and aggregates, using micro-filtration with selected pore sizes and membrane types and depth-filtration media and/or centrifugation.
The invention also integrates viral inactivation and/or viral removal options together with subsequent concentration and formulation steps. Viral inactivation/removal options described include heat inactivation, pH adjustment, UV plus riboflavin, gamma radiation, chemical agents, and viral removal by nanofiltration and/or other chromatography-related approaches. The workflow further includes concentration by tangential flow filtration, removal of plasma proteins by affinity columns, sterile filtration, and lyophilization to obtain a sterile pharmaceutical product.
Claims Coverage
The independent claim covers one inventive feature set: an allogeneic human plasma and platelet derived product pharmaceutical composition with cells and cell debris removed, specified human plasma proteins and platelet proteins including PDGF-AB, and a defined total protein concentration window. The dependent content adds concentration ranges and additional protein composition constraints.
Allogeneic plasma and platelet derived product with cell and debris removal
A pharmaceutical composition comprising an allogeneic human plasma and platelet derived product, wherein cells and cell debris are removed from the product.
Plasma protein set and PDGF-AB concentration range
The product comprises human plasma proteins comprising human serum albumin, immunoglobulins, and fibrinogen, and human platelet proteins comprising platelet derived growth factor (PDGF)-AB at a concentration of about 20 ng/ml to about 160 ng/mL.
Total protein concentration window
The total protein concentration of the composition is greater than 50 mg/mL and less than or about 500 mg/mL.
The claimed invention centers on cell and debris removal in an allogeneic human plasma and platelet derived product, together with the listed plasma proteins, PDGF-AB in the stated concentration range, and the total protein concentration window.
Stated Advantages
Documented Applications
No documented applications found
Interested in licensing this patent?