生物制品病毒安全性评价新法规的变更与解读

20251Q5A(R2)2342025012025-•02340235••NGS•2025WHOICH1.1/MCB

WCBEOPCEOPC

1

MCB

(EOPC)

EOPC

MCB

WCB

MCB

EOPC

WCBMCB

WCBWCBEOPC11.EOPCWCB

MCB4.

CAR-T

MCBWCB

WCB

MCBEOPC1.1MCBWCBEOPCa/LIVCA+++++++

b+

b+

b+++++++++++++

c-+

c+-++--+++++++++

+

+

+

d+++d++-++--++a.

EOPCb.c.NGSd.

MCB

WCBLIVCAEOPCEOPC/LIVCA1.2.3.4.5.MCB

EOPC/LIVCANGS6.EOPC/LIVCA/7.8.9.

1.1.2-

/

MCB

WCBDNASTR RFLP

PCR

EPIC-PCRPCR34301.

/2.3.4.

343034301.2-1101MCB

WCB 10

ml1%

21.2.

11012~25℃

5

(

)•30~35℃

20~25℃

•1.2.3.4.

1.2-/107

1101

2

4

1.2.

11013.1101

/33011.2.

1.2-

6

……

2~8℃

7 33021BHK21-70℃-60℃1

107

1

107

1/4

2 7 1

7

2871.2.3.4.5.

-60℃6.

1/427.

288.1.2-10.2%~0.5%2-8℃

3020~25℃

302~8℃

30

20~25℃

302~8℃

7

(CMV)

28

8.9.10.11.

28

14

28

28281.2-222420%

4

1.

B

2.3.1.2-1.2-//24202>1

1070.010.12815~20g10>1

1070.030.5219~1110>5

1060.23~45~710>2

1060.55350~500g5>4

1055.0421.5~2.5kg5>2

1059.00.1

102110

0.1ml21284.5.3R2.1.2-3•(PERT

PBRT

)(1

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• 1

107

2001

107

200WHO

TRS

978 200PCRPCR

ELISA

PCR•Mus

dunni

SC-1PERT

S+L-

XC

1.2-3

CEF

1.2.

1.2-3CHO

NS0

Sp2/0VeroDNARNACHO

BHK-21

NS0

Sp2/01.2.

CHO

NS0

Sp2/0Vero

IDU

PBMC

CAR-T

DNA1.2-4/MCB

WCBMAPRAP

HAP/

HAV

HBVHCV

HIV-1/2

HTLV-1/2

B19

EBHCMV

-6/7/8/

SV40SFV

SIV

SRV TSTLV•1.2.3.4.

SFV

SRVT STLV5.

MCB

EOPCqPCRt-NGS

1.2-5MCB/WCBEOPC/

3604107

/MCB/WCB

EOPC1.2.

EOPC

1.2-6MCB/WCB

EOPCMCB/WCB

EOPC1.2.

EOPC3.4.

1.2-7CHO

CHO

1.2.MVM1.2-8NAT

NGS

NATPCR

NGSNGSNGS/DNA

RNANGSNGSPCR

NGSNGSNGS

ICH

Q5A

R2

NGSNGSNGS1.2-•……•2(TPD50)

……•

SF9

28℃2

37℃1.2-•DNA

(

)MRC-5

2BS

KMB17.WI-38

FRhL-2CHONSO

Sp2/0

Vero•(

)

DNA

3;

DNA•1.2-MCB/WCB

EOPC

(

)MCB/WCB

EOPC

(

)(MCB/WCB

EOPC

(

)

1.2-8~12

14

1000

50

500

G

Q

5020050

G

Q

1000

500

20090%Poison

31.2.

10005002003.

501.2-1000

(

)500

(

)200

(

)472613171058531809036301793.53

1000200202502ICH

Q5A(R2)ICH

Q5A(R2)ICH

Q5A(R2)2025

ICH

Q5A(R2)-1ICH

Q5A(R2)20250234/MCBWCBLIVCAMCBWCBEOPCMCB

EOPC

LIVCAWCBWCB

MCB-2ICH

Q5A(R2)2025PERT

TEMTEM

A

CMus

dunniSC-1PERT

-

S+L-XCCHO

VeroPERT TEM

PCRMus

dunniSC-1PERT

S+L-

XCCHO

VeroCHO

SF9-3ICH

Q5A(R2)202528NGS287NGSNGSCHO

NS0

SP2/0NGSNGSNGS

NGSNAT

MAP

RAP

HAPNAT

NGS03ChP

CDEICHQ5A

USP

FDA

9CFRCMCC/ATCCATCC/&FTM

30-35℃TSB

20-25℃FTM

30-35℃TSB

20-25℃&&-128280.2%

0.5%0.5%O2/

23/

3PCR-2NATNAT

NGSHRSV

LCMV

Reo-3

SV

ECTV

MAV

PVM

MuLV

MVMMAP—16

ECTV

HRSV

K

Virus

LDMLCMV

MMV

MAV

MCMV

TMEV

MHV

EDIM

PVM

MPyV

Reo-3

SV

MTVHAP—5

LCMV

PVM

Reo-3

SV

SV5RAP—9

HRSV

KRV

TMEV

PVM

RCVReo-3

SV

SDAV

ToolVEB

EBV

HCMV(HIV-1/2

HTLV-1/2)

HAV

HBVHCV

B19

HPVHPyV

HAdVHHV-6/7/8EBV

HCMV

HIV-1

HIV-2

HTLV-1

HTLV-2HAV

HBV

HCV

B19

HPV

HPyV-JC

HPyV-BK

HAdV

HHV6

HHV7

HHV8SV40

SFVSIV

SRV TSTLVSV40

SIV

SFV

SRV

STLV-34(Vero

BT

MDBK

MRC-5)2(Vero

BT)23

BPIV-3BAV-3

BVDVBPV

Reo-3RVIBRVBRSV

BTVBPyV4PPV

PCVTTSuVPAVTGEV

PHEVReo-3

BVDVRV6-4CHOMCBWCBEOPCUPBPCR

SNP√√√√√√√a√√√√√√√DNAqPCR√√√√28MRC-5

VERO√√√√√√√√√√√√TM-PERT√√√Mus

dunni√√√qPCR

/√√)qPCR√CHO√√√qPCR√√

a.CHOMCBWCBEOPCUPBPCR

SNP√√√√√√√a√√√√√√√DNAqPCR√√√√28MRC-5

VERO√√√√√√√√√√√√TM-PERT√√√√√√Mus

dunni√√√√√)qPCR√CHO√√√qPCRqPCR√√√

a.04•••CNASGMP

GLP

CNAS+2018NMPA

FDA

ICHEMAGLP

GMP•••CMA

CNASGMP

GLP

CNAS+•1800+5000+•200+5000+•100%200+

IND7+

BLA•100%50+

IND6+

BLACHO293Vero••CMA

CNASGMP

GLPB+ACNAS

CN