i 1 2 MCB MCB WCB in vitro CAL in vitro CAL In vitro 5 In vivo
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- さわ あみおか
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1 EU ICH ICH
2 i 1 2 MCB MCB WCB in vitro CAL in vitro CAL In vitro 5 In vivo
3 ii in vivo
4 BSE BSE DNA in vitro in vivo in vivo 3 1
5 MCB 1 MCB 2
6 1 MCB WCB in vitro CAL MCB WCB CAL 1 MCB in vitro in vivo MAP WCB WCB CAL WCB MCB WCB CAL WCB WCB 1 3
7 WCB MCB MCB in vitro CAL in vitro in vitro WCB MCB MCB WCB CAL 1 CAL in vitro in vivo 1 NAT MCB CAL induction 4
8 In vitro In vitro In vivo in vitro MAP RAP HAP 5
9 1 3 1 in vitro NAT MCB 6
10 7 robustness relevant specific non-specific A R Murine Leukemia Virus 3 CHO C127 BHK
11 8 3 3
12 . MCB 9
13 3 in vitro C A R Murine Leukemia Virus Epstein-Barr Virus EBV B 10
14 Pseudorabies Virus robustness GMP 11
15 12 ph 2 2 1L
16 CHO 2
17 ph mock run 14
18 TEM
19 2 1 log log 10 16
20 1mL 8 log 10 8 log 10 1mL log
21 18
22 In vitro In vitro Cell Age MCB PDL Virus RNA DNA 2 Adventitious Virus Relevant Virus Specific Model Virus Endogenous Virus Epstein-Barr Virus EBV Bovine Papilloma Virus Non-specific Model Virus robustness Non-endogenous Virus MCB 19
23 Viral Clearance Process Characterization of Viral Clearance robustness Process Evaluation Studies of Viral Clearance Virus Removal Virus-like Particles Adventitious Virus Minimum Exposure Time Cell Substrate Production Cells Endogenous Virus Non-endogenous Virus Inactivation 20
24 MCB Master Cell Bank MCB WCB MCB MCB WCB MCB Unprocessed Bulk WCB Working Cell Bank WCB MCB 21
25 1 MCB WCB a CAL b c d c c d d e e e In vitro f In vivo f g g h. CAL in vitro. 1 WCB CAL WCB CAL in vitro in vivo 1 MAP RAP HAP i
26 In vivo In vitro RT RT RV TEM RT RV a RT NAT ii
27 MAP HAP RAP Lymphocytic Choriomeningitis Ectromelia Virus 2, 3 Hantaan Virus 1, 3 Virus LCM 1, 3 Hantaan Virus 1, 3 Pneumonia Virus of Mice PVM 2, 3 Kilham Rat Virus KRV 2, 3 K K Virus 2 3 Reovirus Type 3 Reo3 1, 3 Mouse Encephalomyelitis Virus Theiler s GDVII 2 Lactic Dehydrogenase Virus LDH 1, 3 Sendai Virus 1, 3 Pneumonia Virus of Mice PVM 2, 3 Lymphocytic Choriomeningitis SV5 Virus LCM 1, 3 Rat Coronavirus RCV 2 Minute Virus of Mice 2, 3 Mouse Adenovirus MAV 2, 3 Mouse Cytomegalovirus MCMV 2, 3 Mouse Encephalomyelitis Virus Theiler s GDVII 2 3 Reovirus Type 3 Reo3 1, 3 Sendai Virus 1, 3 Sialoacryoadenitis Virus SDAV 2 Toolan Virus HI 2, 3 Mouse Hepatitis Virus MHV 2 Mouse Rotavirus EDIM 2, 3 Pneumonia Virus of Mice PVM 2, 3 Polyoma Virus 2 3 Reovirus Type 3 Reo3 1, 3 Sendai Virus 1, 3 Thymic Virus 2 in vitro iii
28 A B C 2 D 2 E 2 1 ( ) 3 1 ( ) 3 1 ( ) MCB 3 CHO iv
29 in vivo SPF Specific Pathogen-Free in vivo v
30 SV40 Polyomavirus maccacae 1 Sabin 1 Human Polio Virus 1 Sabin Parainfluenza Virus Influenza Virus Sindbis Virus RNA HSV-1 Pseudorabies Virus DNA 3 vi
31 nm * Vesicular Stomatitis Virus Rhabdo Vesiculovirus RNA RNA Parainfluenza Virus Paramyxo Paramyxovirus C Type C RNA MuLV Retro Oncovirus RNA Sindbis Virus Toga Alphavirus BVDV RNA Flavi Pestivirus Pseudorabies Virus Herpes DNA Sabin 1 Poliovirus Sabin Type 1 RNA Picorna Enterovirus RNA Picorna Encephalomyocarditis Virus EMC Cardiovirus 3 RNA Reovirus 3 Reo Orthoreovirus SV40 DNA Papova Polyomavirus Parvoviruses DNA Parvo Parvovirus vii
32 quantal method quantitative method TCID Tissue-Culture-Infectious-Dose assays % 0.5 log 0.5 log 95% 95% s 95% a 95% (s 2 a 2 ) 1L ml p viii
33 p ((V v) V) n V(L) v(l) n V V v p e -cv c 1L c ln p -v 1mL 1L p c p L mL 37% 95% ix
34 log 10 V 10 a (V ) (10 a ) V 10 a (V ) (10 a ) Ri 10 Ri ((V ) (10 a )) ((V ) (10 a )) 1 x
35 10 6 ml L 10 3 ml 1 (10 6 ml) (10 3 ml ) xi
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