Sealantium Medical Ltd.

Omrix Biopharmaceuticals Inc.

Orgad Laub

Eran Cohen

Yotam Schwartz

Israel Nur

Liliana Bar

Nadav Orr

Daniel Cohn

Matthew Zarek

Zarek Matthew

A method of production of a tissue sealing patch is disclosed. The method comprises applying a vacuum to a heated work surface; applying a solution of a biocompatible polyurethane polymer to the work surface and spreading it over the work surface with a polymer blade; evaporating the solvent; heating the work surface above the softening temperature of the polymer; spreading powdered tissue sealant material over the polymer film; incorporating the tissue sealant material to a depth of 20-60 &#x3bc;m in the film by pressing on a release sheet placed over the powder and polymer film; removing the release sheet from the adhesive patch material; releasing the vacuum; cooling said work surface; and removing the adhesive patch material from said work surface. The biocompatible polymer preferably comprises PEG-caprolactone-lactic acid units connected by urethane linkages, the PEG having a molecular weight of 3000-3500 amu, and a CL:LA:PEG ratio of 34:2:1.

Method for preparation of tissue adhesive patches

A method for measuring the adhesive strength of a hemostatic tissue patch. Two patches are attached to facing surfaces with a side that would normally seal tissue exposed. Liquid is placed on one of the patches to activate the hemostatic agent, the patches held together long enough to adhere to one another, and then pulled apart. The force necessary to detach them is measured, thereby providing a determination of the adhesive strength of the patch. In contrast to literature methods, the inventive method provides excellent reproducibility.

Method for determining the adhesive force of a hemostatic tissue sealant patch

A method of production of a tissue sealing patch is disclosed. The method comprises casting a polymer film from a biocompatible polyethylene glycol-caprolactone-lactide triblock copolymer (PECALA); softening the polymer film; placing a powdered tissue sealant material on a surface of said polymer film; and, pressing said polymer film to at least partially incorporate the sealant material into said surface of said polymer film. In some embodiments of the invention, the polymer film is created by heating and evacuating a work surface; applying a solution of PECALA to said work surface; adjusting a polymer blade to a predetermined height above said work surface; spreading said solution of PECALA over said work surface with said polymer blade; and evaporating said solvent. The PECALA preferably comprises PEG-CL-LA units connected by urethane linkages, PEG having a molecular weight of between 3000 and 3500 amu, and a CL:LA:PEG ratio of 34:2:1.

Fibrinogen-based tissue adhesive patch

A novel fibrinogen-based tissue adhesive patch is disclosed. The patch comprises a backing made from a non-permeable biocompatible polymer film into which a fibrinogen-based sealant is incorporated. In preferred embodiments of the invention, the biocompatible polymer film comprises units of a biocompatible block copolymer such as a polyethylene glycol-polycaprolactone-DL-lactide copolymer connected by urethane linkages, and the fibrinogen-based sealant comprises fibrinogen, thrombin, and CaCl. In contrast to similar patches known in the art, the polymer backing serves to seal the tissue to which the patch is applied, and the sealant acts only to bind the patch to the affected tissue. The patch does not include any mesh, woven, or non-woven component. Methods of production and use of the patch are also disclosed.

Fibrinogen-based tissue adhesive patches

An improved fibrinogen-based tissue sealing patch having a degradation time of less than two weeks is disclosed. The patch comprises a polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer film in which the PEG-CL-LA units are preferably connected by urethane linkages and into a surface of which a fibrinogen-based sealant comprising less than 8 mg/cmfibrinogen and less than 10 IU/cmthrombin has been incorporated. In preferred embodiments, the polymer film comprises PEG having a molecular weight of between 3000 and 3500 and a CL:LA:PEG ratio of 34:2:1. Methods of production and use of the patch are also disclosed.

The present application relates to an immunoglobulin preparation comprising anti-hepatitis B antibodies for subcutaneous administration and to uses thereof, including methods for treating, preventing and/or reducing a disease, disorder or condition associated with hepatitis B virus.

Subcutaneous administration of anti-hepatitis B antibodies

A concentrated, immunoglobulin composition for treating subjects vaccinated against or infected with a pathogenic microorganism, is made by (a) selecting a population of individuals previously vaccinated against antigens associated with the pathogenic microorganism; (b) identifying very high titer individuals by determining the level of specific antibodies immunoreactive with the pathogenic microorganism in the blood of the individuals; (c) combining blood from the very high titer individuals; and (d) purifying and/or concentrating the product of step (c). A concentrated immunoglobulin composition can include specific antibodies immunoreactive with a pathogenic microorganism, wherein the titer of specific antibodies is at least 5 times higher than the average titer of specific antibodies of a population of individuals previously vaccinated against antigens associated with the pathogenic microorganism. The composition has a relatively high protein concentration and a low percentage of protein aggregates. The pathogenic microorganism is preferably smallpox virus or vaccinia virus.

Intravenous immunoglobulin composition

A method for preparing a concentrated, immunoglobulin composition for treating subjects vaccinated against or infected with a pathogenic microorganism, comprising: (a) selecting a population of individuals previously vaccinated against one or more antigens associated with the pathogenic microorganism; (b) determining the level of specific antibodies immunoreactive with the pathogenic microorganism in a blood or blood component of the individuals to identify very high titre individuals having a very high titre of the specific antibodies; (c) combining blood or blood components comprising immunoglobulins from the very high titre individuals; and (d) purifying and/or concentrating the product of step (c), thereby obtaining a concentrated immunoglobulin composition. Also disclosed is a concentrated immunoglobulin composition comprising specific antibodies immunoreactive with a pathogenic microorganism, characterized in that the titre of specific antibodies of the composition is at least 5 times higher than the average titre of specific antibodies of a population of individuals previously vaccinated against one or more antigens associated with the pathogenic microorganism. The composition has a relatively high protein concentration and a low percentage of protein aggregates, and is therefore suitable for both iv and im administration. In a preferred embodiment, the pathogenic microorganism is smallpox virus or vaccinia virus.

Growing community of inventors

Tel Aviv, Israel

Orgad Laub