北京市门头沟区2011—2012学年度第一学.pptVIP

The transmissible spongiform encephalopathies and allergen vaccines Allergenic products - summary most allergen extracts are produced without any bovine components mold extracts are stored and propagated in culture media, some of which contain bovine components of uncertain origin the risks associated with these contaminations are minimal TSE timeline (selective) 5/91: CBER letter to manufacturers 12/93: FDA letters to manufacturers 12/97: USDA expands list of banned countries to include all of Europe 4/00: CBER letter to manufacturers 5/00: 1st memo to Allergen Manufacturers 7/00: TSEAC/VRBPAC (/ ohrms/dockets/ac/00/transcripts/3635t1.rtf) 8/00: 2nd memo to Allergen Manufacturers Risk assessment Quantify/estimate risk based on animal source (time, place) tissue processing/dilutions protein doses associated with IT route-specific risks Categories I: high infectivity (brain, spinal cord, eye) II: medium infectivity (ileum, lymph nodes, proximal colon, spleen, tonsils, dura mater, pineal gland, placenta, CSF, pituitary gland, adrenal gland) III: low infectivity (distal colon, nasal mucosa, peripheral nerves, bone marrow, liver, lung, pancreas, thymus) IV: no detected infectivity (blood clot, feces, heart, kidney, mammary gland, milk, ovary, saliva, salivary gland, seminal vesicle, serum, skeletal miscle, testis, thyroid gland, uterus, fetal tissue, bile bone, cartilage, connective tissue, hair, skin, urine) Special categories glycerol most glycerol in allergen extracts is of plant origin not considered to be infectious milk not considered to be infectious gelatin originally not considered to be infectious TSEAC now recommends against parenteral use Estimating the infectivity of bovine-derived media tissue LD50/g g tissue/cow cows/lot regional risk (per cow) process reductions medium LD50/lot medium LD50/mL Media supplements No bovine components Proteose peptone 2 Proteose peptone 3 Peptamin Neurospora culture agar Malt extract broth Bovine gelatin only