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"5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N, 7@07>: 5B8:5B:8. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.:3131C;L9>==5 A5@54>28I5 7 D5=>;>28< G5@2>=8< (7 3;N:>7>N), 500 3!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 500 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.:30,532C;L9>==5 A5@54>28I5 7 D5=>;>28< G5@2>=8< (7 ;0:B>7>N), 100 3!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 100 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.:30,733C;L9>==5 A5@54>28I5 7 D5=>;>28< G5@2>=8< (7 <0;LB>7>N), 100 3!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 100 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.:30,134!5@54>28I5 ;V3;5@0, 100 3!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 100 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.:30,135C;L>= 0:>=:V, 100 3!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 100 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.:30,636>682=89 1C;L9>=, 500 3!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 500 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.:30,537"@L>EFC:@>289 70;V7>2<VICNG89 030@, 100 3!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 100 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.:30,138 V4:5 F8AB8=-A5;5=VB>25 A5@54>28I5, 500 3!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO. #?0:>2:0  ?>42V9=0, ?;0AB8:>2V :>=B59=5@8. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.:30,539!5@54>28I5 !;0=5F-0@B;V 4;O 5=B5@>:>:V2, 500 3!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 500 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. 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