pemanfaatan prg untuk industri vaksin dan...

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Pemanfaatan PRG

Untuk Industri Vaksin

dan Keamanannya

Widya Asmara

Dasar pengertian / Terminologik• Apa Rekayasa Genetik ?

– Teknik yang digunakan untuk memotong dan

menyambung bahan genetik dari organisme yang

berbeda, untuk menghasilkan hibrida dan/atau

memodifikasi bahan genetik organisme tertentu,

sehingga dihasilkan organisme baru yang

memiliki kombinasi bahan genetik baru yang

dapat diwariskan.

• Apa GMO:

– Setiap organisme (animals, fish, plant,

microorganism) yang memiliki kandungan materi

genetic yang sudah dimodifikasi secara artifisial,

sehingga mempunyai sifat dan/atau

menghasilkan produk seperti yang diinginkan.

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Berdasar Peraturan Perundangan Organisme Hasil Modifikasi Genetik (GMO):

Setiap organisme hidup yang memiliki kombinasi bahan genetik baru yang diperoleh melalui pemanfaatan bioteknologi moderen (UU.21 Th.2004, ps.3 butir.g)

Bioteknologi moderen:

Aplikasi dari teknik perekayasaan genetk yang meliputi teknik asam nukleat in-vitro dan fusi sel dari dua jenis atau lebih organisme diluar kekerabatan taksonomis (UU.21 Th.2004, ps.3 butir.i ~ PP.21 Th.2005, ps.1 ay.8)

Produk Rekayasa Genetik (PRG):

Organisme hidup, bagian-bagiannya dan/atau hasil olahannya yang mempunyai susunan genetic baru hasil penerapan bioteknologi modern (PP.21 Th.2005, ps.1 ay.8)

Penggolongan Obat Hewan

Penggolongan Obat Hewan:

Penggolongan berdasarkan sediaan:

Berdasarkan sediaannya, obat hewan dapat digolongkan ke

dalam sediaan biologik, farmakoseutika, premiks, dan obat

alami (UU No.18/2009 ps.49 ay.1)

Sediaan Biologik:

Adalah Obat Hewan yang dihasilkan melalui proses

biologik pada hewan atau jaringan hewan untuk

menimbulkan kekebalan, mendiagnosis suatu penyakit

atau menyembuhkan penyakit melalui proses

imunologik, antara lain berupa vaksin, sera (antisera),

hasil rekayasa genetika, dan bahan diagnostika biologik

(Permentan No.17/2017 ps.1 ay.5)

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Peredaran Obat Hewan

Syarat Peredaran:

Obat hewan yang dibuat dan disediakan dengan

maksud untuk diedarkan harus memiliki nomor

pendaftaran (UU No.18/2009 ps.50 ay.1)

Untuk memperoleh nomor pendaftaran, setiap obat

hewan harus didaftarkan, dinilai, diuji, dan diberikan

sertifikat mutu setelah lulus penilaian dan pengujian

(UU No.18/2009 ps.50 ay.2)

Obat Hewan yang Merupakan PRG

• Jika berdasarkan kajian PPOH/KOH dan atau

pernyataan dari produsen bahwa sediaan obat

hewan yang didaftarkan tersebut merupakan PRG,

maka sesuai peraturan perUndang-undangan yang

berlaku untuk proses pendaftaran selanjutnya

diteruskan ke KKH-PRG, untuk memperoleh

sertifikat keamanan hayati.

Contoh obat hewan PRG adalah vaksin hewan PRG

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Vaksin PRG

Vaksin dengan bioteknologi modern / based on genetically modified organisms (GMO) Sub-unit vaccines

Live attenuated vaccine :

• Site-directed mutagenesis

• Reverse genetic

Vectored vaccines

DNA vaccines

Sangat diperlukan dalam pengendalian penyakit (hewan maupun manusia)

Genetically Modified vaccine ? What disease to be prevented:

Bacterials, Virals, Parasites, Fungal?

Vaccine Type (Antigen Contents) ?

Killed, inactivated bacteria or viruses

Live attenuated bacteria or viruses:

Conventional attenuation

Attenuation with GE technology

Subunit vaccines

Purified components from pathogens

Recombinant proteins

Synthetic peptides

Vectored vaccines : bacterial or viral

Reverse Vaccinology

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Classification of Vaccines

Vaccines

Conventional Vaccines Recombinant Vaccines

Live Vaccines

(conventional

attenuation)

Inactivated

Vaccines

Purified

Antigen /

SubUnit

Vaccines

Subunit

Vaccines

Live Vaccines

Attenuation

by GE Vectored

Vaccines

DNA Vaccines

Reverse Vaccinology

Latar Belakang pemakaian vaksin PRG

Pros: Melalui rekayasa genetik dapat dihasilkan jasad renik

PRG untuk vaksin yang memiliki sifat baru, seperti penurunan keganasan dan peningkatan imunogenisitas

Dengan rekayasa genetik vaksin dapat diproduksi tanpa melibatkan agen (isolat) patogenik asli lapangan yang berisiko hazard, akan tetapi hanya memanfaatkan gen dan ekspresi antigen protein secara heterolog.

Dengan rekayasa genetik memungkinkan produksi vaksin dengan efikasi yang baik, secara lebih mudah, dan aman.

We use vectored vaccines as study model

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Vectored Vaccine vs Killed Vaccine

Killed vaccine mainly only induced humoral immunity

Antibody attack favors antigenic variation in pathogens' surface molecules (B-cell epitopes)

Vectored Vaccine induced humoral & cellular immunity (CTL)

CTLs favor variation in any parasite molecule that can be presented by the host's MHC system (T-cell epitopes)

MHC class I binding specificity depends on short peptides of about 8–10 amino acids

MHC class II binds to a sequence of about 13–17 amino acids

The balance of antibody versus CTL defense affects the population dynamics of the pathogen within the host, the time before clearance, and the memory properties of host immunity against reinfection

B cell epitopes

B cell epitopes have approximately 15 – 25 amino acids when defined by spatial contact of antibody

Almost all naturally occurring B cell epitopes/antibody epitopes studied so far are composed of amino acids that are discontinuous in the primary sequence but brought together in space by the folding of the protein.

Single mutation sometimes can reduce the relative binding constant, reduced sensitivity & specificity, and/or eliminate binding ability

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T cell epitopes T cell receptors recoqnise T cell epitopes

T cell epitopes resulted from processed antigen

T cell epitopes always linear/sequensial epitopes

T cell epitopes have approximately 8-17 amino acids

T cell epitopes less sensitive to point mutation (antigenic variation)

Does it means vectored vaccine has more advantages than killed/inactivated vaccine to prevent viral infection?

Latar Belakang argumen vaksin PRG

Cons:

Pemanfaatan jasad renik PRG untuk vaksin hewan dan ikan mengundang kekhawatiran bahwa vaksin hewan dan ikan tersebut kemungkinan dapat menimbulkan risiko pencemaran lingkungan yang berpotensi menimbulkan gangguan terhadap kesehatan hewan, ikan dan manusia

Kemungkinan timbulnya risiko tersebut perlu diminimalkan melalui pendekatan kehati-hatian (precautionary approach).

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Arguments against GMO

1. Potential safety risk for animal and/or humans

Unintended Consequences

2. Potential safety risk for environment

Could spread

3. Benefits multinational corporations

not consumers or developing nations

4. Genetic Engineering is playing God

Not Natural to move genes between species

Need to be clarified


Some Clarification:

1. Potential safety risk for animals/humans, due to:

– Unintended Consequences

To be confirmed by checking:

GMOs are carefully reviewed / tested and documented before products are available.

Every activities that may create important risk on environment, biodiversity and human health, have to carry out Environmental Risk Analysis

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– Could spread

To be confirmed:

Genetic stability, no gene flow

No environmental contamination that has a

negative effect

No adverse risk to biodiversity

(Environmental Risk Analysis to be carried out)

clarification……



• not consumers or developing nations

To be confirmed:

Promote the general welfare (benefit based analysis)

Maintain people’s rights (individuals, groups, corporations)

Ensure justice: burdens and benefits must be fairly shared

(Nagoya Protocol ?)

clarification…..

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4. Genetic Engineering is playing God ?

Not Natural to move genes between species or to modify genes

Ethically wrong ?

To be Confirmed:

Is it only GMO really unnatural?

No, because: Any form / efforts to improve the character of any organism can be regarded as unnatural, because almost always some human intervention when modifying any organism into the desired characters

Clarification……

Arguments againstGenetically Engineered Foods

1. Potential safety risk for humans

Unintended Consequences


Could spread


not consumers or developing nations

4. Genetic Engineering is playing God

Not Natural to move genes between species

Due to those argument :

That’s Why GMO/GEP Should be Properly Regulated

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Why should be Regulated ?

Regulations are designed to protect people, other living organisms, and the environment

Regulation are intended to allow us to safely use the benefits of biotech.

Help in developing and using biotech products and services.

Responsible Agencies Three Ministerial have primary responsibilities for

administering laws related to biotech:

MoH : BPOM: to assure the safety of food and drugs

MoA : decide whether products are safe to use on cultured crops or animals

MoE&F : to assure quality environment

KKHPRG (Biosafety Commission)

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Alur Aplikasi/Regisrasi Vaksin PRG

Proponen Kementan

POH: PPOH/KOH

KLKH

KKHPRG

TTKH-PRG

Data Yang Dikaji

Informasi Vaksin PRG

Informasi Jasad Renik dalam Vaksin PRG

Informasi Sifat Genetik Jasad Renik PRG

Informasi Keamanan Lingkungan

Komunikasi Risiko Lingkungan

Rencana Pengelolaan & Pemantauan Risiko

Jasad Renik / Vaksin PRG

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Assessment Process for Environmental Biosafety

3. Minister / Non-Ministerial Govt.

Agencies

4. Request for Recommendation

(14 days)

5. M o Envt.

6. assign

me

nt

(14d

ays)

7. assign

me

nt

9. Asse

ssme

nt re

sult

15. Re

co

mm

en

datio

n

& c

ertific

ate asse

ssme

nt

16. Sertificate (safe / not safe)

(14 days)

1. Applicant /Proponent

2.A

pp

licatio

n

17.D

ecisio

n to

Rele

ase

14. Delivery of public response

11. Assignment

Source: Deputi MENLH

ASSESSMENT, RELEASE AND DISTRIBUTION, AS WELL AS USE OF GEP

Assessment of GEP shall be conducted prior to release and distribution

Biosafety Commission: to conduct assessment

In the event that the assessment relates to technical evaluation, Biosafety Commission assign Biosafety Technical Team to conduct assessment of technical document and advanced test.

Biosafety Clearing House: to publicize the summary of the result of GEP assessment conducted by Biosafety Technical Team through mass media both printed and electronic in addition to official news

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ASSESSMENT, RELEASE AND DISTRIBUTION, AS WELL AS USE OF GEP

Based on the result of Biosafety Technical Team’s assessment and input from the community, Biosafety Commission shall propose its recommendation

Competent Minister or Competent Head of Non Ministerial Government Agencies shall use thecertificate and recommendation as basis for consideration for the issuance of Decree on theRelease and /or Distribution of the said GEP, in accordance with applicable legislations.

Conclusion Concerning biosafety:

Released GEPs are safe: any released GEPs have been reviewed by Biosafety Commission

Concerning ethical/moral issues:

Concerning issues of unnaturalness: GMO not differ to such extent from conventional biological character improvement which until now can also be accepted

Concerning ethical-religion issues: to be assessed on a case-by case basis

In making assessment of possible costs-benefits ratio, possible risks for human health & environment, etc., it is necessary to proceed on a case-by-case basis.

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Conservation of biodiversity

Safe & Sustainable use

Fair and equitable sharing of benefits

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