投影片 1

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1 (95 年 5 3 )

2 離猪行異論

3 離 hfix 猪

4 ( ) 類列列列力殺年力

5 列力力殺殺鱗鱗 ( )

6 列殺泌 ( )

7 列類異類類類 ( )

8 類列列塞 Glyphosate Herbicide ( 年年 ) Monsanto ( 都 ) ( )

9 列塞 Glyphosate Tolerant Crops Monsanto 都 1.EPSPS (!) 2.CP4 EPSPS 來 Agrobacterium sp. strain CP4 ( ) 葉綠 4.

10 列 EPSPS + 塞 EPSPS CP4 EPSPS 塞 Line ( Monsanto,1995) ( )

11 倫理易 ( )

12 ( )

13 Bt (ECB, European Corn Borer) ( )

14 金利葉數 ( )

15 降 ( )

16 What are concerned 1. LMO cross-boundary transportation 2. Biodiversity 3. Sustainable agriculture Risk P(Exposure) P(Hazard/E) Risk : Assessment, Management and Communication

19 a Ground beetls c a b b Springtail (Folsomia candida) c Biomass GMHT genetically modified herbicide tolerant

20 Nature Biotechnology, October 2002

21 1. 來年 (GM) 不量 2. 理 GM 3. 行 GM GM GM

22 (Nature Biotechnology, October 2002)

23 不 1. a. 度易力 b. 2. a. 不利 b. 3. 異來

24 離猪行異論

25 降療 1989 年

26 (Pursel et al., 1989)

27 (GH) 類 IGF-I 猪猪率猪 GH Tg 猪 IGF-I Tg 猪率 11 量 20 飼料率 21 量量 = = National Hog Farmer, p. 35. Dec., 1997

28 猪 1. 飼料利率猪 56% 2. 猪 a. b. 了 c. 75% d. 糧猪 e. 猪飼飼料率猪 5-10

29 Frankenpig

30 Scientists develop environmentally friendly pig Why GM is Good for Us Genetically modified foods may be greener than organic ones. By Lee Silver Newsweek International March 20, 2006 issue - Farm-raised pigs are dirty, smelly animals that get no respect. They're also an environmental hazard. Their manure contains phosphorus, which, when it rains, runs off into lakes and estuaries, depleting oxygen, killing fish, stimulating algae overgrowth and emitting greenhouse gases. During the 1980s, phosphorus pollution killed all aquatic life in the 42km-long Mariager Fjord of Denmark an ecological disaster that prompted European governments to impose strict regulations on pig farming. It didn't solve the problem.

31 離 (94/10/25)

32 1. 2. 力易數量行 3. 類切飼 4. 不易易殺

33 行理理 3. 理理 ( ) 行

34 理令年 6 9 理年年 1 31 理年理

35 1. 87 年理年利理

36 列利不切更年年金行行行金

37 理 (91/11/15 ) 不 (DNA) (RNA) 流力行類

38 理行利利不列來來六理類例

39 度飼理飼理狀說流 ( ) 利

40 六 ( ) 不行樂行

41 離不利 2. 不利 3. 不利 4. 行? 流力行類

42 例 1. 類猪 2. 類 3. A 4. 猪 5. 猪猪 6. 猪猪 9. 異 HLA-II hdaf hho-1 猪猪 10. 行 --

43 1. 不利 2. 不利 3. 不利

44 GM Codex 行 GM GM

45 量異類理樂飼易殺理

46 離

47 1. 2. WTO 3. 理立離

48 行 A C B D 理蘭理

49 利

50 理

51 年度 91 年 8 ~93 年 2 D E F C B A 爐 SPF G 理猪離度年年年 A. SPF B. 猪 C. 猪 D. 猪 E. 切 F. 飼料 G. 理

52 年度 91 年 8 ~93 年 2 猪參 SPF 猪猪

53 2004 年 3 3

54 G. 猪 c m cm 泥離泥

55 理泥理泥離泥理理

56 年度 93 年 1 ~93 年 12 - 離車

59 2 欄 (18 欄 ) (20 欄 ) 飼

61 路

62 飼 60

63 欄

65 92 年 1 93 年

66 猪猪猪 Lobby

67 1F GLP ( ) 1F 2F 2F 路 A

68 3F 冷 3F 3F 路冷 2F 1F B

69 IOS/IEC 17025:1999 理年年飼料飼料飼料飼料飼料飼料飼料臨精

70 猪 CNLA

71 離 A. PCR PCR Southern blot RT-PCR ( ) ( ) (FISH) 7 B. 理 24 精狀 8 C. 異 ( 異 ) 1 D. 14 異異行理異理 E. 異 14 F. 飼料例行 10 78

72 猪 SPF 猪離

73 離猪行異論

74 Classes of Biopharmaceuticals Recombinant Proteins Vaccines Monoclonal Antibodies Gene Transfer Products Somatic Cell Therapy Products Synthetic Peptides Antisense, antigene, ribozymes Diverse grouping of products.no standard development programme appropriate for all

75 利利利 1-2 年 2-4 年 IND 4-8 年 1-2 年臨臨 I 臨 II 臨 III NDA 理理臨理 ;CMC( ) 3 10 金 12 年利年 100 金

76 Product for Pre-Clinical & Phase I/II studies Full scale GMP batches used for preclinical and clinical trials Ideally, 3 used to set release specifications for clinical material 1 established as a reference standard Characterised Used in preclinical safety studies 1 used for clinical study Product used in Phase I study should be essentially the same as that intended for marketing Ideally, manufacturing at commercial scale

77 General Considerations in the Design of a Non-clinical Development Programme 1. Selection of relevant animal species 2. Dose regimen 3. Toxicity Studies 4. Bioanalysis and PK 5. Immunogenicity 6. Immunopharmacology & Immunotoxicity 7. Genotoxicity & Carcinogenicity 8. Safety Pharmacology 9. Reproductive Toxicity

78 A. αanti-trypsin PPLTherapeutics, UK 年年 Phase II Phase III 2003 年 B. Antithrombin III GTC Biotherapeutics 1. heparin 1991 年年 phase III ( 行 ) 2004 年 2006 年 3 New Zealand Farm of PPL Therapeutics 1,130, June 2003 alpha 1-antitrypsin 臨

79 Nature Reviews: Drug Discovery, 2002.

81 a lyophilized powder stored at room temperature; b lyophilized powder stored under refrigeration; c human serum albumin (HSA)-containing liquid stored under refrigeration; d ultrapure liquid formulation (HSA-free) stored under refrigeration; and e ultrapure lyophilized powder stored under refrigeration. Figure 2 Immunogenicity of different human IFN- 2A preparations. The immunogenicity of human interferon- 2A (IFN- 2A) is highly dependent on the formulation and storage conditions, as shown here by the mean-population antibody titre in patients treated with different IFN preparations.

88 Biopharmaceutical Products Biological Biological origin origin Raw materials Manufacturing process Purified product Biosafety test Efficacy assay

89 Points to consider in the production and testing of new drugs and biologicals produced by recombinant DNA technology (FDA/1985) Points to consider in the characterization of cell lines used to produce biologicals (FDA/1993) Quality of Biotechnology Products: Analysis of the Expression Construct in Cells Used for Production of R-DNA Derived Protein Products (ICH/1995) Guidance for Industry: Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product (FDA/1996) or a Monoclonal Antibody Product for In-Vivo Use

90 ( ) (Transgenic founder: G0) 立 (founder strain) 立六理臨

91 Standard Clinical Stages of Drug Development and Corresponding Success Rates Using Conventional Product Development Approach Discovery (2-10 Years) Preclinical testing Laboratory and animal testing Compound Success Rates by Stage 5,000-10,000 Screened 250 Biosimilars Bioequivalences Phase III (1,000-3,000 patient volunteer to monitor adverse reactions to long-term use) Phase l (20-80 healthy volunteer used to determine safety and dosage) Phase II ( patient volunteer to look for efficacy and side effects) FDA Review/ Approval Year 5 1 Source: Pharmaceutical Research & Manufactures Association (Modified from Ell Lilly: The Evista Project )

92 離猪行異論

93 猪行異 (Nowak R, Science 1994)

94 hdaf 猪臨臨猪年

95 Animal Cloning Cloned Mini Pigs May Also Be Organ Donors (November 2002 ) Heart and Renal Transplantation 1. Don t undergo HAR 2. Don t require Ab adsorption 3. Don t require complement inhibition 4. Heart survive 50/60~179 days 5. Kidney survive 30 days 6. Kidney plus thymus survivals increased to 81 days (Kuwaki et al., Nat Med.)

97 Xeno-tourism

98 療來異離行異異度異臨理不切

100 57 WHA (World Health Assembly, WHA) 2004 年 5 22 識 1. 行異 2. 數異 3. 異 4. 異力 5. 行行狀 )

101 異猪錄 1. Chapman et al., N. Eng. J. Med. 333: (1995) 2. Patience et al., Nature Med. 3: (1997) PK-15 離類 3. Le Tisser et al., Nature 389: (1997) Two sets of human-tropic pig retrovirus. (PERV-A &- B)/PK Wilson et al., J. Virol. 72: (1998) Retrovirus released from porcine primary peripheral blood mononuclear cells infects human cells. 5. Luc et al., Nature 407: (2000) Infection by porcine endogenous retrovirus after islet xenotransplantation in SCID mice ( 臨例類 )

102 猪異猪錄異猪靈類靈類猪類數年猪猪飼猪

103 離猪行異論

104 倫理易葉行 GMO 量 5% GMO 量 1%

105 ( ) Bacillu sthuringiensis 殺類 Bt 殺量粒殺量量不年

106 理 -- 不理不不良理易理行理 GMO 例理料理理理量 GMO ( )

107 理零利益 ( ) 理理

108 Thank You for Your Attention 聆 ( 蘭 )

SanPin 2.3.4.050-96

羅 2.3.4 Enterprises of food and processing industry- (technological processes and raw materials) SanPiN 2.3.4.050-96 Production and sale of fish products 料年羅聯流行行參料類料理冷類類類卵流錄 1 67 料冷