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TRANSCRIPT
Established
in Aug 6, 1890
Moved to Bandungin 1923
Implement Integrated SystemGMP, GLP, GCP, ISO9001, ISO14001, OHSAS18001,
ISO 17025, ISO 27001ERM, CSR Based ISO 26000
State-owned Enterprise (100 %)Vaccine & Antiserum manufacturer
1300 Employee
WHO pre-qualified Vac ( DTP, DT, TT, DTP-HB, m/b/tOPV, Measles and TT, HB in
Uniject, Td, Pentabio)
Knowledge-based, R&D-base Driven
Company in Brief
Vaccine Development : Timeline
DISEASES
BURDEN
SEED
DEVELOP
VACCINE
DEVELOP
CLINICAL
DEVELOP
SCALE-UP
PROD.VACCINE
1 year2-3 years3-5 years3-4 years3 yearsCont
PURIFIKASI
5
PROSES PRODUKSI VAKSIN
PENYIAPAN MEDIA
1
INOKULASI DAN KULTIVASI
2
INAKTIVASI
4
PANEN
3
FORMULASI
6
PENGISIAN & PENGEMASAN
7
FINISH PRODUCT-VACCINE
HARVEST
3
Apabila virus/bakteri telah memenuhi standarjumlah dan kondisi, maka virus/bakteri tersebutdipanen
INACTIVATION
4
Inaktivasi bahan kimia dan panas
Toksin toksoid (ex. Difteri, tetanus)
Konjugasi PRP-TT, konjugat difteri
PURIFICATION
5
Filtrasi dilakukan dengan memberikan tekanan tertentu agar larutan yang ingin dimurnikan masuk melalui membran penyaringan, “dicuci” hingga jutaan kali sehingga pada
akhirnya yang tersisa hanyalah komponen yang diinginkan.
BULK
FORMULATION
6
Preservative
(ex. Thimerosal)
Adjuvant
(ex. Al fosfat)
Stabilizer
(ex. sukrosa, laktosa)
ANTIGENvirus atau bakteriYang dilemahkan
IMUNISASIInjeksi atau oral, aktivasi kekebalan,membentuk
antibodi spesifik
MENIMBULKAN KEKEBALANterhadap serangan
mikroorganisme spesifik
VAKSIN : Produk Biologi
SISTEM IMUN
Respon Imun &
Pertahanan Tubuh Virus
Bakteri
Serangan Benda Asing(Bakteri/Virus)
Menghilangkan Benda Asing
(Bakteri/Virus)
SISTEM IMUN
5-7 Desember 2017 The 6th Islamic Conference Ministry Of Health
INDONESIA
As a Center of Excellence
Vaccine and Biotech Product
PENGAKUAN NEGARA OIC : OIC CENTRE OF EXCELLENCE FOR VACCINE AND BIOTECH PRODUCTS
INNOVATION
CLUSTER
INDONESIA
As hub for
Green Economy
(Vaccine Innovation)
IRAN
As hub for
Energy Innovation
(Nuclear Power)
MALAYSIA
As hub for
ICT Innovation
(Malaysia Super
Corridor)SAUDI ARABIA
As hub for High Tech R & D (King Abdullah
University for Science &
Technology –KAUST)
QATAR
Doha Innovation
Citya for Education
PAKISTAN
COMSTECH
(Biotech)
INDONESIA
As hub for
Green Economy
(Vaccine Innovation)
Organisation of Islamic Cooperation (OIC) VACCINE MANUFACTURER GROUP
International Vaccine Institute (IVI)
Developing Countries Vaccine Manufacturers Network
Islamic Development Bank's Self-Reliance in Vaccine Programs (IDB-SRVP) , Centre of Excellence for Biological
PERAN BIOFARMA DI KANCAH GLOBAL
Collaborating Partner
• Polysaccharides Meningitis• HPV• Inactivated Polio Vaccines (IPV)
• Varicella• Measles Rubella• Japanese Encephalitis (JE)• Pneumococcal
• Rotavirus• Tuberculosis• Typhoid
Conjugate Meningitis, Vi-Typhoid Conjugate*, Hexavalent, MR (10 doses,)* Hep B*, HPV**, IPV Bulk**
• Measles Rubella (MR)• Rabies• Erythropoietin
Rotavirus*, Pneumococcal*, Trastuzumab*, EPO*, sIPV, * HepB(Bulk)**
Keterangan : Kemitraan Komersial
* Kemitraan R&D/Teknologi** Kemitraan Fill & Finish
Pipeline Product Vaksin & Lifescience
ALUR SKEMA PROSES PRODUKSI VAKSIN VIRUS
MediaSel
Media Sel+
Trypsin
Media Sel
Media Sel+
VirusVirus
Penambahan Enzym Trypsin berfungsi untuk melepaskan sel
Trypsin Dibuang dari Media Sel dengan cara Pencucian
Inokulasi/penanaman Virus kedalam Sel yang sudah bersih dari Trypsin
Harvest/Panen Virus dengan memisahkan Virus dari Media Sel