Sản xuất thử nghiệm vắcxin Dengue sống giảm độc lực trên tế bào vero ở quy mô phòng thí nghiệm

NGHIGN COU-TRnO BOI

^m XUAT TH i NGHIEM VACXIN DENGUE SONG GIAM DOC LOC

TREN TE DAO VERO i QUY MO PHONG THI NGHfEM

B 6 TUA N O/StT, HOANG ANH BLfC, HOANG OCfC LOC, NGUYI N THU VAN

Cong ty XfUi MTV VicmvaSrit ph^m s^ 1

Sau khi x3y dUng dirdc quy trinh cOng nghe d quy mo phong thi nghiem, cac loat Ihilr

nghidm vicxin dengue song giam dOc lire tS gia tren te bao Vero da dugfc san xua't ra dat

ygu ciu cha't liT^ng tai cd sil. Dd'i vdl mdi cdng doan cQa qua trinh san xua't d€'u phai tid'n

hanh it nha't tren 3 loat lidn tie'p Si \\\im dinh ve chS't li/dng san pham va tmh d'n djnh cua

quy trinh. Cac kg'l qua cua quy trmh san xua't thuf nghidm nay se la can tS de lUa chon mpt

quy trinh sin xuS't to'l iru cung nhu ap dung cho san xual vdi quy md Idn hdn trong tuofng

lai tai COng ty TNHH MTV VScxin va Sinh phd'm so' 1 (VABIOTECH).

Tir khoa: quy trinh cong nghe, vScxin dengue, te'bao Vero, san xua't vacxin.

PHOT PnoDUCTioN o r

DENGUE IIVE-ATTENUATED

VACCINE IN VEEO CELL AT

THE lADODATODY SCALE

Simsry

After establishment of a production

procedure at the iatioratory scale,

several pilot production lots of

dengue live-attenuated vaccine in

Vero cell have been conducted and

met the local quality requirements.

For each stage of production, at

least 3 consecutive lots have been

conducted in order to validate

the vaccine quality and procedure

stability. The results of pilot

production will be the basic for

the selection of optimal vaccine

production procedure and application

for future upscale production in

Company for Vaccine and Biological

Production No 1 (VABIOTECH).

Kavwards: tecbnologtcal procedure,

dengue vaccine, Vero cell, vaccine

production. J

Dat van de

Dengue la mot trong nhDng benh do virut lay truyen qua mu6i pho bien

nhat b ngUdi, \\S\i hanh chu yeu tai cac vung nhiet ddi va can nhiet ddi tren

the gidi. Pham vi anh hadng va su" phan bo dja ly cua benh nay tang nhanh

chdng trong vong 50 nam qua va To chDc Y te the gidi (WHO) t/dc tfnh

rang, virut dengue la nguyen nhan gay ra khoang 50-100 trieu ca benh mdi

nam tren toan the gidi. Khoang 2 phan 5 dan so tren toan the gidi hien nay

cd nguy cd mac benh nay [1, 9].

SLT lan truyen nhanh chdng cua djch sot dengue dang doi hoi cac td

ChDc, cac qud'c gia tang cudng nd luc kiem scat, phong va chDa benh. Cac

phUdng phap chu yeu nham kiem soat sU lay lan benh sd'f dengue trong

cpng dong bao gom giao due cpng ddng va khd'ng che vector truyen benh.

Viec nang cao y thDc, giao due cong dong ve sD nguy hiem, each phdng

va chdng sdt dengue cd y nghta quan trong nhDng ket qua thu dDdc cdn

nhieu han che. Viec khdng che vector truyen benh dDdc xem la phDOng

phap phdng benh duy nhat cd hieu qua nhung chi phi kha Idn va ddi hdi

mpt chien iDdc lau dai, lien tuc. Hien nay, viec nghien cDu va phat trien

vdcxin dang dDdc hy vong la se dDa ra dDdc mdt giai phap phdng benh cd

hieu qua cao nhat doi vdi benh sot xuat huyet dengue. Cac to chDc y te,

cac qud'c gia cung nhD cac nha san xuat da va dang nd iDc khdng ngDng

trong viec tim ra vacxin phdng benh sdt dengue hieu qua va kmh te nhSm

dDa vao sD dung rdng rai trong cac khu vDc iDu hanh dich [4, 5, 6, 7].

Vdi mong mudn nghien cDu va phat tnen vScxin dengue t^i Vi§t Nam

nhSm mau chdng tiep can vdi cac cong nghe san xuat v&cxin tien tien tr6n

the gidi cung nhD sdm cd dDdc vacxin phuc vu cpng ddng. Cdng ty TNHH

MTV Vacxin va Sinh pham so 1 (VABIOTECH) da tien hanh thanh cong

cac nghien cDu iDa chon va xay dDng he thdng chung giong cho s^n xu^t

vicxin tD cac chung virut cd cac dac tfnh tdt nhat ve di truyen va mi§n

^'^'"'"'°^'CONGNGHt VIET NlSf\, ^