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Aroem Naroeni, DEA, Ph.D.

Biosafety Officer
Institute of Human Virology and Cancer Biology
Universitas Indonesia

Mrs. Aroem Naroeni is IHVCB’s Biosafety Officer located in Salemba, Jakarta. Finishes her Ph.D. in L'Universite d'Aix Marseille II in “Infectious Diseases and Tropical Pathology”, she’s been doing a research on breast cancer stem cells and microenvironment, and HIV antiviral drugs. She’s very concerned with biosafety and risk assessment in medical research and currently she’s developing a guideline for safety and risk assessment to be applied all over Indonesia. The coolest thing is: this will be the first one Indonesia ever have! She knows about our project we’re doing in the lab, so her point of view really matters. Find out her thoughts about our project’s safety assessment and the prospect of synthetic biology development in Indonesia!

Synthetic biology has been developing in Indonesia, but actually there are many issues involved. As a developing country, Indonesia hasn’t had a safety guideline regarding research in Synthetic Biology. But luckily, Indonesian are very “easy-going” and people will try to accept it as long as it can solve problems. A prove of it is shown by a biosimilar products such as erythropoietin, diarrhea drug, and other stuffs that has been commercially published. However, many aspects should be reconsidered including ethics, sustainability, and safety. UI is currently developing a guideline for biosafety and risk assessment for the first time ever in Indonesia. For our project, some things that need to be emphasize is we need to go through more specific study of the safety of virulence gene that would be inserted in the bacteria, and for further research we have to try it in in-vitro, preclinical (animal), and even clinical (human) for the last object.

Is it ethical if you’re inserting bacteria to human body?

Well, ethics depends, but most importantly every project needs preclinical and clinical research so we could know the side effect of the Synthetic Biology application. In Indonesia, some bacteria like Lactobacillus acidophilus have been commercially used to cure diarrhea. These products have been sold for several years until now and the acceptance is actually good.

In Synthetic Biology, people change the resistance of bacteria. People force a plasmid to be inserted in bacteria. In short, changing a natural existence of a life, is it allowed?

In Synthetic Biology and Recombinant DNA, it is allowed because it has been regulated in:
1. NIH Guidelines For Research Involving Recombinant DNA Molecules (NIH Guidelines)
2. UU 21/2005 about Genetically-modified Product Safety
3. For pharmacy product:
• Ministry of Health Regulation 1010/2008 about Drug Registration
• National Agency of Drug and Food Control Republic of Indonesia HK 03.123.10.11.08481/2011

How if the bacteria in our project is really applied in life? Could it cause changes in the environment?

It depends; you should do a preclinical and clinical research. Then, you should seek more about what you’ll use in your project:
• Do you use only some types of proteins or genes? If yes, many of this type of project have been commercialized, so you should only conduct the preclinical and clinical research.
• Do you use the whole bacteria, inserted with genes? If yes, you need to find out more about the virulence factor of the gene and bacteria itself. If it’s considerably safe, you could follow the preclinical and clinical research. Or maybe before preclinical research, you could test it by in-vitro in cells.

How about Synbio in Indonesia?

In Indonesia, there have been researches conducted in Synthetic Biology. GMO have been used in the diagnostic in medical devices. There’s only one company in Indonesia that has been producing vaccines and biosimilar product. A biosimilar is a biological product that is highly similar to a U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product (U.S. Food & Drug Administration, FDA). Biosimilar product that currently been commercialized is Erythropoietin Stimulating Drug. Erythropoietin is a hormone produced mainly in the kidneys, which stimulates the production and maintenance of red blood cells. Recombinant erythropoietin drugs are known as erythropoietin-stimulating agents (ESAs). These drugs are given by injection (shot) and work by stimulating the production of more red blood cells. These cells are then released from the bone marrow into the bloodstream. Until now, the synthetic biology commercialize product in only biosimilar product such as ESD or vaccine.

Is there any regulation about synthetic biology research in Indonesia?

About product commercialization, yes, there are some regulations. Such as:
1. UU 21/2005 about Genetically-modified Product Safety
2. For pharmacy product:
• Ministry of Health Regulation 1010/2008 about Drug Registration
• National Agency of Drug and Food Control Republic of Indonesia HK 03.123.10.11.08481/2011

However, there are no guidelines for researches in synthetic biology in Indonesia. IHVCB follows the NIH Guidelines For Research Involving Recombinant DNA Molecules (NIH Guidelines). Overall, research in synthetic biology in Indonesia is still free of use. This could be a good news because everyone can do researches and propose new ideas, but it could be bad if wrong people misuse this.

That’s why Universitas Indonesia is currently developing a new guideline for biosafety and risk assessment, which could be used generally all across Indonesia. This is the first one Indonesia will ever had! We intend to make boundaries or restrictions so it would reduce the risk of contamination or mutation in the environment or even human. It also contains materials about ethics, because until now ethics only a matter of perception through patient as a human being––there are no limit or boundary against it so the ethics perception between one person and another could be biased. For publication outside Indonesia, international safety guidelines like NIH should be fulfilled. That’s why; every research in UI should fulfill the NIH Guidelines and should pass the risk assessment test before being brought out from the lab. We’ve been listing our researches that have been conducted so we could categorize it.

How should we package our product? Could we use it as a probiotics? And how will people of Indonesia accept it?

If you’re trying to make a probiotics, be careful about the storage because it’ll has short term of expiration date. Back again, you should consider the virulence factor and immunology analysis. I think people in Indonesia are easy to accept something new, as long as the cost isn’t very high. And I think there would be no high cost because nowadays people uses bioreactor so it would be done easily and the cost won’t be too high. For another instance, use lyophilization of bacteria so you could store in in a matter of long time. Professor Akira in Faculty of Mathematics and Natural Science UI has collected bacteria around Indonesia using this method.

Do you think that Indonesia is a bit left behind other countries?

Well, in biosimilar technology, I think Indonesia is quite advanced. The only problem is to find the investor who would commercialize it. And there is no regulation from the government.

How about Intellectual Property Rights?

iGEM has an open source basis in ung.igem.org so if it has become a public domain, everyone could use it. We have to insert notes of: “for research only, for commercial purpose, please contact the author.” If we want to protect our online right in, Indonesia there is also HAKI or Intellectual Property Rights. However, we should pay some money monthly to maintain it.

Professor Masafumi Yohda

Biotechnology and Life Science
Tokyo University of Agriculture and Technology, Japan

YOHDA sensei is a biotechnology and life science professor, and he’s also a lecturer in Engineering in Tokyo University of Agriculture and Technology (TUAT). He came to Indonesia as a guest lecture in Society of Biological Engineering Universitas Indonesia Student Chapter (SBE-UISC) featuring UI Synbio Club Seminar entitled “Application of Biotechnology in Industry.” He has come to several Nobel Prize Meetings and very famous, yet he still gave us many advices on our Lab Work. Luckily, he’s here with us to provide some information regarding synthetic biology application projection in Asia, also problems involving application of Synbio in Japan. Check it out!

Synthetic biology really has big prospects in the world. We need ideas––yet we need breakthroughs if we want to achieve more from it. Asia is being forward in many aspects over the past several years. However, Major findings from the Wilson Center on “Tracking the Growth of Synthetic Biology” in 2013 shows that the number of entities conducting research and commercial applications in Synthetic Biology in Europe and US is very high, but Asia has been left behind. Japan––as the most developed country in Asia––is known of its high technology development. Depart from this statement; Professor Yohda from TUAT (Tokyo University of Agriculture and Technology) stated that there are restrictions in Japan towards GMO application. This condition biased the usual fact and in real life, a part of Japanese people are intolerant of science implementation, so the government of Japan protect all of the people including the conventionalist by restricting synthetic biology and especially GMO. Safety module might works, but back to reality. Every machine that works can’t be 100% effective, and so is safety module. There’s always a chance of failure of microorganism to escape and contaminate environment, especially because the size of microorganism and bacteria is very small. Although there are chances of failure, Prof. Yohda as a scientist wants a higher degree of Synbio development in Japan. He’s excited about synthetic biology development because it will cope problems many industries. People need to take more risks and accept this novel development. [Read more…]