이종이식 생성물 및 방법

• Main Authors: ADKINS JON, HOLZER PAUL, CHANG ELIZABETH J, MONROY RODNEY L
• Format: Patent
• Language: Korean
• Published: 16.07.2021
• Subjects: AGRICULTURE; ANIMAL HUSBANDRY; BEER; BIOCHEMISTRY; CARE OF BIRDS, FISHES, INSECTS; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, ORSURGICAL ARTICLES; CHEMISTRY; COMPOSITIONS THEREOF; CULTURE MEDIA; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; ENZYMOLOGY; FISHING; FORESTRY; HUMAN NECESSITIES; HUNTING; HYGIENE; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICALARTICLES; MEDICAL OR VETERINARY SCIENCE; METALLURGY; METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS INGENERAL; MICROBIOLOGY; MICROORGANISMS OR ENZYMES; MUTATION OR GENETIC ENGINEERING; NEW BREEDS OF ANIMALS; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; SPIRITS; TRAPPING; VINEGAR; WINE

인간으로의 임상 이종이식을 위한 생물학적 생성물 및 돼지가 하나 이상의 세포외 표면 글리칸 에피토프를 발현하지 않도록 생물학적으로 조작된 게놈을 갖는 비야생형의 생물학적으로 조작된 돼지를 생산하는 것을 포함하는 인간으로의 임상 이종이식을 위한 생물학적 생성물을 제조하는 방법은 폐쇄된 지정된 병원체가 없는 무리에서 바이오버든-감소 절차에 따라 사육되고, 여기서, 상기 생물학적 생성물은 돼지가 안락사된 후 수확되고 상기 생성물은 돼지로부터 무균적으로 제거되고, 상기 생물학적 생성물은 멸균을 포함하여 처리되고, 상기 생성물을 멸균 용기에 저장하고, 상기 생성물은 하나 이상의 세포외 표면 글리칸을 포함하지 않고, 특정 지정된 병원체가 없고, 생물학적으로 활성이고, 이종이식 후 혈관화할 수 있는 살아있는 세포 및 조직을 포함한다. A biological product for clinical xenotransplantation into a human and a method of preparing biological product for clinical xenotransplantation into a human involving producing a non-wild type, biologically engineered swine having a biologically engineered genome such that the swine does not express one or more extracellular surface glycan epitopes, is free of certain pathogens, is reared according to a bioburden-reducing procedure in a closed designated pathogen free herd, wherein the biological product is harvested following the swine being euthanized and the product is aseptically removed from the swine, the biological product is processed involving sterilization and storing the product in a sterile container, and the product does not contain one or more extracellular surface glycans, is free of certain designated pathogens, is biologically active and comprises live cells and tissues capable of vascularizing after xenotransplantation.