ARAH DAN ROADMAP PENGEMBANGAN VAKSIN

ERMAN TRITAMA
Disampaikan pada perkuliahan “Public Health and Community Medicine 4” UNISBA
BIO FARMA sebagai GLOBAL PLAYER
Supply ke 132 Negara
UN Agencies (UNICEF, PAHO),
& Bilateral.

Next Generation

Industri Life Science

1. Vaksin
Current 2. Imunosera
Industri Vaksin 3. Biosimilar /Antibodi monoklonal
• Vaksin 4. Stem cell
• Imunosera 5. Kit diagnostika (rapid test)
6. Produk darah
 KEBUTUHAN PENGEMBANGAN VAKSIN : NASIONAL & GLOBAL

Vaccines are one of the most effective

public health tools and protect millions of
lives each year from infectious diseases.
As such, they are also critical to reach the
Millennium Development Goals (MDGs),
particularly the goals to reduce infant and
child mortality (MDG4) and to combat
HIV/AIDS, malaria and other diseases
(MDG6)

Hence, continued efforts are needed to develop new and improved vaccines and to assure
their safe and effective implementation
GLOBAL EFFORT

MDG 4

GIVS
2011-2020
 Vaccines prequalification priority list 2018 -2020

High priority Medium priority Low priority No priority

DTwP-Hep-Hib-IPV BCG DT DTwP-HepB+Hib (liq+FD)

DTaP-IPV, DTaP-HepB dll Kolera DTwP-Hib (Liq) DTwP-HepB-Hib (Liq)

Dengue DTwP DTwP-HepB/DTwP+Hib (Liq Hib
+ FD)
HPV HepA DTwP-Hib-IPV / DTwP-IPV mOPV1
Malaria Seasonal Flu HepB tOPV
MR M JE R

MMR MenA Konj MenAC (PS) TT

Pneumo Konj MenCW Konj mOPV2

IPV MenACWY Konj mOPV3
bOPV (1,3) Td Tifoid (PS)
Rabies Varicella

Rotavirus

TCV
YF

http://www.who.int/immunization_standards/vaccine_quality/priority_pq_vaccines_2018_2020/en/
POTENSI PASAR
 PENYEBARAN PENYAKIT
• Nearly 70% of the world’s children lack Tifoid
access to rotavirus vaccines 1

1. IVAC, VIMS Report: Global Vaccine

Introduction, September 2015. International
Vaccine Access Center, Johns Hopkins
Bloomberg School of Public Health

Pneumonia
 POLIO ERADICATION IS A TOP PRIORITY Strategi
FOR THE FOUNDATION Dunia

"The fight to eradicate polio is the thing I spend most of my time on. It is the next big milestone in global
health and development"
- Bill Gates, United Nations - A Global Call to End Polio, 27th September, 2012*
*Bill Gates' prepared remarks for UN Global Assembly - A Global Call to End Polio
Source: http://www.gatesfoundation.org/media-center/speeches/2012/09/bill-gates-united-nations-global-assembly-address-on-fighting-polio
Bases for National Vaccine Needs

Disease
Burden
ITAGI

WHO

MOH Priority &

Recommendations
 Routine Immunization Schedule

Infant Immunization Programme Elementary School Based

Age (months) Vaccines Grade Vaccines
< 24 Hours Hepatitis B 1 DT, MR
1 BCG, bOPV1 2 Td
2 Pentabio, bOPV2 5 Td,HPV*
3 Pentabio, bOPV3 6 HPV*
4 Pentabio, bOPV4 + IPV
9 MR * Selected locations

Booster dose, MR & Pentabio 18-24 Months

Targets of National Immunization
Program in Indonesia 2015-2019
Maintaining
Maintaining maternal and
polio- free status neonatal tetanus
elimination

Meet global and

New Vaccines
regional targets
Introduction Plan
(Measles elimination
(MR, JE, HPV, PCV)
and Rubella control)
 New Vaccines Introduction Plan
Vaccine 2015 2016 2017 2018 2019
MR Phase I, Java Phase II, outsite
Island Java
HPV Demonstration East Java, Manado and All Jogjakarta
Project, Jakarta some cities Makassar City
JE Bali Province Manado City
PCV East and All Lombok All West nusa Tenggara and
West Island, and selected district in east Java
Lombok selected district and West Java
in Bangka
Belitung
Rota Demonstration Project in
selected area
 TEKNOLOGI VAKSIN

Teknologi Penghantaran
Mekanisme Intranasal Prefilled
Sistem imun syringes
Tablet terlarut
Adjuvan Jet injectors
Gel Thermoresponsive
Micropartikel Intradermal
devices
Vaksin
Live attenuated
Inactived
Toxoid
Protein
Polisakarida
DNA
Konjugat
Virus like particles
Antigen
 Platform Teknologi yang Dibutuhkan

Aman

Kapasitas besar
Biaya rendah
Dapat digunakan secara luas
Respon luas

Produksi Mudah
Harus Memenuhi

Bebas Paten

Courtesy Rick Bright (BARDA)

Setting R&D Yang Harus Dipertimbangkan
Seed Lot
- Sejarah seed harus jelas - Seed bank : GMP seed
- Seed terkarakterisasi - Penyimpanan seed

Bahan Baku
- Secara komersial tersedia - sebaiknya Animal free origin
- Spesifikasi jelas

Proses
- Mudah diperbesar skalanya - ICH : Quality By Design (“Design space”)
- Mudah diulang - Bebas isu paten

Product (Vaccine) presentation

- Memenuhi keinginan publik
- Halal
- WHO PQ : WHO product characteristics
 HARAPAN  MENGHASILKAN VAKSIN IDEAL

Efisien untuk semua umur

Dapat memberikan perlindungan seumur hidup setelah 1 kali vaksinasi

Mudah diberikan (lebih baik kalau dapat per oral)

Tidak memberikan efek yang tidak diharapkan (adverse reaction)

Stabil dalam kondisi tertentu

Tersedia dalam jumlah tidak terbatas dan murah harganya

Bio Farma Menerapkan Platform Industri Masa Depan (UNIDO)

Social Environmental
ISO 26000 Mainstreaming ISO 14000

Enterprises
Mainstream : Operations
R&D PRODUKSI MARKETING VALUE
MORE EFFICIENT

APPLICATIONS
Energy, And New
INNOVATIVE

Raw Practices Green

Material Technologies
 KONDISI SAAT INI
KONDISI GLOBAL KONDISI NASIONAL
Akses teknologi semakin Bio-diversity, Geo-diversity,
√ sulit.
√ Cultural-diversity tersedia.
Kerja sama riset untuk Human capital tersedia,
√ komersil tidak mudah.
√ namun keahliannya belum
dimanfaatkan maksimal.
Riset dan teknologi Riset dan fasilitas riset
√ semakin mahal.
√ belum terpadu.
Transfer material semakin Ketergantungan bahan dan
√ rumit.
√ hasil riset luar.
 Vaccine Development
R&D R&D, produksi
Vaccine Preclinical Pilot scale Clinical Regulatory Commercial
Exploratory Candidate Vaccine studies manufacturing Development Approval manufacturing
Design Characteriza-
tion

 Understand  Bulk manuf.  Clinical lots  Documents/

the disease  Formulation  cGMP Data (CTD)
 Epid. Data  Identity  QC
 Identify  Purity  QS
antigen  Standards
 Stability

 Seed history  Safety  Regulatory

 GCP
 Presentation  Toxicology compliance
 Phase I
 Route of  Teratology  cGMP
 Phase II
administr,  Etc.  QC
 Phase III
 QMS

Est. 10 yrs 1 yr 3 - 4 yrs 1 yr

x x x x
 DENGAN SIAPA KAMI BERPARTNER

Global FORUM
RISET
VAKSIN
OIC/OKI
NASIONAL
WHO
Regional
BMGF JP

PATH AU
Nasional
TH LITBANGKES RISTEKDIKTI BPPT
IVI LIPI KONSORSIUM UNIVERSITAS
MY
Biotech
 NATIONAL PARTNERSHIP RISTEK-DIKTI, LITBANGKES, BIO FARMA : CONSORTIUM

1 2 3 4 5

NEW TB VACCINE DENGUE VACCINE HEP B VACCINE HIV EPO

UGM EIJKMAN ITB

UGM UI UI UI UN. UDAYANA LIPI

UNPAD ITB UNAIR EIJKMAN UNS LITBANGKES

UGM
AL-AZHAR

BPPT PSSP
BPPT
UNAIR UNHAS LIPI BIO FARMA

PSSP BPPT
BIO FARMA

LITBANGKES
LITBANGKES
BIO FARMA
AL-AZHAR

BIO FARMA BIO FARMA

NATIONAL PARTNERSHIP RISTEK-DIKTI, LITBANGKES, BIO FARMA : WORKING GROUP

1 2 3 4 5 6 7

INFLUENZAE MALARIA ROTAVIRUS STEM CELL PNEUMO- HPV POLICY

COCCUS AND
DELIVERY TAG Imunisasi
BPPT SYSTEM
UI UI UNAIR UI
EIJKMAN LITBANGKES
LITBANGKES
EIJKMAN UNIBRAW UNPAD
LITBANGKES
UGM UNPAD
UGM UNPAD EIJKMAN
UNAIR UGM RISTEK

UI IPB UI UN. ANDALAS

LITBANGKES BPOM
BPPT Subdit Imunisasi
UNDIP IPB ITB
UN. UDAYANA

BALITVET BIO FARMA ITB Ditjen HKI

BIO FARMA UN. ATMAJAYA
UNAIR UN. UDAYANA KIN

BIO FARMA BIO FARMA BIO FARMA BIO FARMA BIO FARMA
 KERJA SAMA INTERNASIONAL : TEKNOLOGI VAKSIN BARU

Seasonal Flu
S-IPV
BIKEN
whole cell JPRI
pneumococcus
PATH O/W adjuvant
UNIL

nOPV2 Gates Melb. Pam2cys

Bio Farma Univ. Antigen BF

IPT
Lipotek Lipovaxin
Rabies New TB

MCRI IVI Vi typhoid

CapBio conjugate
Rotavirus HiB
 Timeline Produk Baru
Produk Exp PreClinical Fase I Fase II Fase III Licensure

Tifoid Konjugat 2020

wPneumo Bekukan -
Rotavirus 2020

MR 10 dosis (Bridging study) 2019/2020

Hepatitis B 2020/2021

Flu Pandemi 2021/2022

Seasonal Flu (quadrivalen) 2023

sIPV 2022/2023

Heksavalen 2022/2023

aP 2022/2023

nOPV2 2021/2022
TERIMA KASIH

Thank You

Dedicated to Improve
Quality of Life
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