Abstract: Recombinant proteins, manufactured with genetic engineering techniques, like its counterpart human derived proteins, for example, recombinant Factor VIII have the potential for transmission of viruses and bacteria which are used in the process. This invention demonstrates that one may dry heat at high temperature, the lyophilized final Factor VIII product even at high temperatures and still show significant VIII:C activity. Such terminal dry heat will assure that there has been recontamination.

Abstract: Recombinant proteins, manufactured with genetic engineering techniques, like its counterpart human derived proteins, for example, recombinant Factor VIII have the potential for transmission of viruses and bacteria which are used in the process. This invention demonstrates that one may dry heat at high temperature, the lyophilized final Factor VIII product even at high temperatures and still show significant VIII:C activity. Such terminal dry heat will assure that there has been recontamination.

Abstract: A biopsy needle, suitable for obtaining bone marrow biopsy cores, includes an outer tube member having a lumen extending therethrough, and at a distal end of the outer tube member an opening is provided for receiving a biopsy core. At the distal end, the outer tube member is generally oval in cross-section and thereby has an elongated dimension and a narrow dimension. An inner tube member is slidable and rotatable in the lumen of the outer tube member and has a set of pincers at its distal end. With the inner tube member slid through the lumen of the outer tube member and the pincers positioned at the distal end of the outer tube member and aligned with the elongated dimension, the pincers are in an open position. However, the pincers can be closed thereby to grasp and cut a biopsy core by rotating the inner tube member so that the pincers are aligned with the narrow dimension of the outer tube member.

Abstract: A bone marrow biopsy needle provided with blades which cut and retain a biopsy core. In one embodiment, the cutting blades of the needle are hinged at the distal end of the needle and are mechanically coupled to an actuator at the proximal end of the needle. The needle is preferably formed with inner and outer walls to provide a space therebetween for the mechanical coupling. The cutting blades are retained in a dead space against the outer wall of the needle when the needle is open. In lieu of a hinged arrangement, the outer wall of the needle may be tapered at its distal end so that the blades are forced together when they are pushed forward. In another embodiment, the cutting blades are pre-curved inward, but are retained against the inner surface of the needle wall until pushed forward. In yet another embodiment, the distal ends of the cutting blades rest within a curved circumferential recess provided in the needle wall, and, when pushed forward, move together to cut and retain the biopsy core.

Abstract: A process to disinfect units of red blood cells by adding an oxidizing agent, for instance ozone generating compounds, in solution to a unit of RBC's (RBC's) or compounds generating ClO.sub.2, the RBC reducing enzymes such as cytochrome b.sub.5 reductase will prevent or reverse oxidative changes, however, the viruses or other microorganisms do not have such enzymes. By adding RBC reducing enzymes to the RBC's before sterilization, the RBC's are further protected from the oxidizing sterilizing solution. The RBC's can be put in storage medium containing a reducing agent. The oxidizing agent may be generated from activated ceramic particles which will generate O.sub.3 (ozone) in solution. This is a convenient and economic method of RBC sterilization. The activated ceramic particles generating O.sub.3 in solution may also be added to units of whole blood.

Abstract: A method of producing a vaccine comprising providing a quantity of the disease-causing entity, treating the quantity to remove or disrupt a majority of the nucleic acid present in the quantity sufficient to render the quantity non-infective while maintaining the structure of the proteins and glycoproteins on the surface of the entity to render the vaccine protective. A method of producing a vaccine to human pathogenic retroviruses comprising the steps of partially solubilizing a quantity of the virus to produce a suspension, adding a proteinase to the suspension to release viral nucleic acids from the viral coat proteins, treating the suspension to disrupt or remove sufficient viral nucleic acids to render the suspension substantially or completely non-infective and verifying the sufficient disruption or removal of viral nucleic acids from the suspension.

Abstract: A bone marrow biopsy needle provided with blades which cut and retain a biopsy core. In one embodiment, the blades of the needle are hinged. In a further embodiment, the cutting blades are provided at the end of an inner tube which travels within an outer tube. In one embodiment, the outer tube is tapered at its distal end to push the blades together. In another embodiment, the cutting blade is pre-curved inward. In yet another embodiment, the distal ends of the cutting blades rest within a curved circumferential recess provided in the needle wall, and, when pushed forward, come together to cut and retain the biopsy core.

Abstract: A process to inactivate viruses or bacteria by disinfecting whole blood products and blood products, including red blood cells, plasma and plasma fractions is disclosed. The process includes providing a disinfectant composition may also be applied to plasma fractions.

Abstract: A method to inactivate viruses or to disinfect blood products, for instance units of red blood cells, wherein a disinfectant or virus inactivating chemical is made isotonic or nearly isotonic, and wherein the red blood cells are exposed to isotonic disinfectant to inactivate any agent which may be present, for example HIV-1 virus which causes AIDS. The method may also be applied to plasma fractions and corneas.

Abstract: A method to inactivate viruses or to disinfect blood products, for instance units of red blood cells, wherein a disinfectant or virus inactivating chemical is made isotonic or nearly isotonic, and wherein the red blood cells are exposed to isotonic disinfectant to inactivate any agent which may be present, for example HIV-1 virus which causes AIDS. The method may also be applied to plasma fractions and corneas.

Abstract: It is found that blood clotting-factor products previously subjected to monoclonal purification or solvent-detergent treatment or both may be further subjected to a sequence of heating steps without excessive loss of usable product to reduce the infectivity of a virus (such as hepatitis- or AIDS-causing virus), if present. The heating is performed while the concentrate is lyophilized (freeze dried). The heating steps in the sequence are for two or more different times, and at two or more different temperatures. After the heating sequence, the concentrate is reconstituted for use. This sequential method contemplates greater inactivation of different viral forms, or reduction of the heating required, or both. Reduction of heating requirements may appear as reduced overall heating time, or reduced aggregate power consumption, or both. Advantages include heightened quality-control assurance level.

Abstract: Factor VIII concentrate, or Factor IX concentrate, or fibrinogen concentrate, or other clotting-factor product, is subjected to a sequence of heating steps to reduce the infectivity of a virus (such as hepatitis- or AIDS-causing virus), if present. The heating is performed while the concentrate is lyophilized (or dried by another process). The heating steps in the sequence are for two or more different times, and at two or more different temperatures. After the heating sequence, the concentrate is reconstituted for use. This sequential method contemplates greater inactivation of different viral forms, or reduction of the heating required, or both. Reduction of heating requirements may appear as reduced overall heating time, or reduced aggregate power consumption, or both. Advantages include heightened quality-control assurance level. Also possibly, the invention offers some potential for preparation of vaccines against the virus, if sufficient quantity of the virus is present in the concentrate.

Abstract: Factor VIII concentrate, or Factor IX concentrate, or fibrinogen concentrate, or other clotting-factor product, is subjected to a sequence of heating steps to reduce the infectivity of a virus (such as hepatitis- or AIDS-causing virus), if present. The heating is performed while the concentrate is lyophilized (or dried by another process). The heating steps in the sequence are for two or more different times, and at two or more different temperatures. After the heating sequence, the concentrate is reconstituted for use. This sequential method contemplates greater inactivation of different viral forms, or reduction of the heating required, or both. Reduction of heating requirements may appear as reduced overall heating time, or reduced aggregate power consumption, or both. Advantages include heightened quality-control assurance level. Also possibly, the invention offers some potential for preparation of vaccines against the virus, if sufficient quantity of the virus is present in the concentrate.

Abstract: It is well known that the transfusion of human blood and blood constituents, or the transplantation of corneas and sclerae, carries a substantial risk of transmission of AIDS and many other diseases. This disclosure describes a method of disinfecting certain blood constituents--particularly the red cells, platelets and proteins--or disinfecting corneal and scleral tissues, to make them safer for human transfusion or transplantation, while respectively maintaining their biologic or optical function. A sterilizing solution is prepared from, e.g., a commercially available disinfectant (such as LD.RTM. of Alcide Corporation) containing primarily lactic acid and sodium chlorite. Normal saline solution is used as diluent instead of distilled water. The blood constituent or cornea or sclera is exposed to the disinfectant for a time sufficient to inactivate or reduce the infectivity of disease agents.

Abstract: It is well known that the transfusion of human blood and blood components carriers with it a substantial risk of transmission of AIDS and many other diseases. This disclosure describes a method of disinfecting red blood cells to make them safer for human transfusion, while maintaining their biologic activity. A sterilizing solution is prepared from, e.g., a commercially available disinfectant (LD.TM. Alcide Corporation) containing primarily lactic acid and sodium chlorite. Normal saline solution is used as diluent instead of distilled water. The red cells are exposed to the disinfectant for a time sufficient to inactivate or reduce the infectivity of disease agents. The normal-saline environment prevents or deters hemolysis. The blood cells are then washed with normal saline solution until the disinfectant concentration is insignificant. The blood is then safe for human transfusion.