**1. Introduction**

Since the outbreak of 2007 Avian Influenza, Indonesia had been starting to accumulate more knowledge and experiences related to biosafety and biosecurity. While Indonesian researchers were focusing on biorisk management of high pathogenic bioagents, students were also being exposed gradually to more sophisticated biological hazards through the utilization of synthetic biology and genetic modifications on their own researches.

Trainings and workshops on aforementioned issues had been organized regularly, and at the same time, High Containment Facilities as BSL3 had been built in some locations with supports from various International organizations such as BEP, WHO, and FAO. One of the projects is the establishment and evaluation of Biorisk Management in University of Indonesia [1].

In 2005, WHO has established International Health Regulation (IHR) to strengthen health security, which defined as "activities required to minimize the danger and impact of acute public health events that endanger the collective health and population living across geographical regions and International boundaries."

IHR has purpose to provide swift response to global threats of spread of diseases without imposing significant disturbance to international traffic and trade [2]. One of implementations of IHR was by establishment of Global Health Security Agenda (GHSA) consortium to give participant countries such as Indonesia a capacity to prevent, detect, and respond to this spread, regardless of the root causes such as natural, deliberate, or accidental occurrences.

To achieve these goals, GHSA developed concept called "Action Packages," where Biosafety and Biosecurity are important elements. This Action Packages consist of:

Prevent 1: Antimicrobial Resistance Prevent 2: Zoonotic Disease Prevent 3: Biosafety and Biosecurity Prevent 4: Immunization Detect 1: National Laboratory System Detects 2 and 3: Real-Time Surveillance Detect 4: Reporting Detect 5: Workforce Development Respond 1: Emergency Operation Centers Respond 2: Linking Public Health with Law and Multisectoral Rapid Response Respond 3: Medical Countermeasures and Personnel Deployment Action Package [3].

A country achievement to GHSA Active Pack implementation is assessed voluntarily by a Joint External Evaluation (JEE). Indonesia was assessed back in 2017 by JEE with several recommendations:


The report also noted the absence of National Biosafety and Biosecurity manual and the absence of select agent list and National Inventory of Biological agent [4, 5].

One Health University Network and One Health Laboratory Network were established to promote Biorisk Management at university level, which was participated by Indonesian well-known university such as Gadjah Mada University, Airlangga University, and Syiah Kuala University with pilot project at their own medical and veterinary labs. Major outcomes from this project were the establishment of institutional biosafety committee, a certification program for professional biorisk management, and the development of laboratory assessment tools.

In National scope, Indonesian Biosafety Association was founded in 2011 with objectives to:


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*Nurturing Responsible Future Generation of Scientists: Focus on Maintaining International…*

• become an efficient, functional, and sustainable biosafety organization;

• build interaction and communication between scientists and nonscientist professionals in order to support the development of biorisk in Indonesia;

• conduct training to ensure the implementation of safe laboratory quality and standards that are carrying out according to principles of biorisk

In addition, Biorisk Management standard had been successfully formulated under Indonesian National standard (SNI) nos. 8340:2016 and 8434:2017, which

References from National and International Biorisk Management Guidelines in health, education, veterinary, and agriculture areas in various countries were sought to provide an in-depth view on this matter. It is noted that scientific journals on biorisk management and responsible science are still limited; therefore, some

Definition of select agent according to the US Centers for Disease Control and Prevention (CDC) is "biological agent and toxins determined to have the potential to pose a severe threat to public health and safety to animal and plant health or to

There are 67 organisms in CDC's list agents, which developed from initial list which contained 42 agents and toxins introduced in 1997. It included some agents that could affect both humans and animals (for example, *Bacillus anthracis* and *Francisella tularensis*) but not those whom affecting animals and plants only. It was

• international commitments not to use disease as a weapon are embodied in the Geneva Protocol, which was signed in 1925 and entered into force in 1928. This protocol prohibited the usage of chemical and biological as weapons; however, it did not band the production, storage, or transfer of those materials and

• the Biological and Toxin Weapons Convention (BWC), which was signed in 1972 and entered into force in 1975 as well as Chemical Weapons Convention in 1993. This closed the gap, which was not covered by Geneva Protocol previously.

sources could only be obtained from unpublished reports and webpages.

**3. Defining select agents and risk group in Indonesia**

well as a source for continuous information updates; and

was adopted from CWA 15793 and CWA 16393, respectively [7–10].

At this report, we are focusing on the following areas:

• emerging and reemerging disease researches; and

• researches that use emerging technologies in Indonesia.

• provide a forum to represent the interests and needs of biorisk practitioners, as

*DOI: http://dx.doi.org/10.5772/intechopen.90050*

management [6].

**2. Methods**

animal or plant products."

preceded by some events such as:

• select agents and risk group;

*Nurturing Responsible Future Generation of Scientists: Focus on Maintaining International… DOI: http://dx.doi.org/10.5772/intechopen.90050*


In addition, Biorisk Management standard had been successfully formulated under Indonesian National standard (SNI) nos. 8340:2016 and 8434:2017, which was adopted from CWA 15793 and CWA 16393, respectively [7–10].

At this report, we are focusing on the following areas:


#### **2. Methods**

*Contemporary Developments and Perspectives in International Health Security - Volume 1*

natural, deliberate, or accidental occurrences.

Prevent 1: Antimicrobial Resistance

Prevent 3: Biosafety and Biosecurity

Detect 1: National Laboratory System Detects 2 and 3: Real-Time Surveillance

Detect 5: Workforce Development

JEE with several recommendations:

Respond 1: Emergency Operation Centers

IHR in a country multisectoral level;

Prevent 2: Zoonotic Disease

Prevent 4: Immunization

Detect 4: Reporting

Package [3].

IHR has purpose to provide swift response to global threats of spread of diseases without imposing significant disturbance to international traffic and trade [2]. One of implementations of IHR was by establishment of Global Health Security Agenda (GHSA) consortium to give participant countries such as Indonesia a capacity to prevent, detect, and respond to this spread, regardless of the root causes such as

To achieve these goals, GHSA developed concept called "Action Packages," where Biosafety and Biosecurity are important elements. This Action Packages consist of:

Respond 2: Linking Public Health with Law and Multisectoral Rapid Response Respond 3: Medical Countermeasures and Personnel Deployment Action

A country achievement to GHSA Active Pack implementation is assessed voluntarily by a Joint External Evaluation (JEE). Indonesia was assessed back in 2017 by

1.to formulate necessary regulations to allow development and integration of

2.to define a coordination mechanism between IHR and global security task

3.to evaluate and simplify bureaucratic structure of decision makers to enable

The report also noted the absence of National Biosafety and Biosecurity manual and the absence of select agent list and National Inventory of Biological agent [4, 5]. One Health University Network and One Health Laboratory Network were established to promote Biorisk Management at university level, which was participated by Indonesian well-known university such as Gadjah Mada University, Airlangga University, and Syiah Kuala University with pilot project at their own medical and veterinary labs. Major outcomes from this project were the establishment of institutional biosafety committee, a certification program for professional

force with relevant local ministries, agents, and institution; and

biorisk management, and the development of laboratory assessment tools.

(research institutions, diagnostics, industry, and hospitals);

In National scope, Indonesian Biosafety Association was founded in 2011 with

• build a proper capacity in biorisk management in laboratories in Indonesia

• collaborate with government and other authorities by providing technical inputs for national strategies, policies, and guidelines on biorisk management as well as advocate for a better understanding of biorisk management itself;

Indonesia to act fast to national and international issues.

**182**

objectives to:

References from National and International Biorisk Management Guidelines in health, education, veterinary, and agriculture areas in various countries were sought to provide an in-depth view on this matter. It is noted that scientific journals on biorisk management and responsible science are still limited; therefore, some sources could only be obtained from unpublished reports and webpages.

#### **3. Defining select agents and risk group in Indonesia**

Definition of select agent according to the US Centers for Disease Control and Prevention (CDC) is "biological agent and toxins determined to have the potential to pose a severe threat to public health and safety to animal and plant health or to animal or plant products."

There are 67 organisms in CDC's list agents, which developed from initial list which contained 42 agents and toxins introduced in 1997. It included some agents that could affect both humans and animals (for example, *Bacillus anthracis* and *Francisella tularensis*) but not those whom affecting animals and plants only. It was preceded by some events such as:


Article I of the BWC states that "Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain:



**185**

**Figure 1.**

*Hepatitis and Ebola virus.*

*Nurturing Responsible Future Generation of Scientists: Focus on Maintaining International…*

Currently, there are 183 countries that have ratified BWC [11].

**4. Emerging and reemerging infectious diseases**

Other important subjects are emerging and reemerging infectious diseases, which could pose a major threat to global public health. On the other hand, these subjects also attract many scientists to obtain good publications and funding. Despite of all efforts in biorisk management, unfortunately the handling of pathogenic viruses remains a likely source of infection, and mortality, among laboratory

Accidental infections of workers in hospitals or research laboratories are an emerging threat mainly due to the increasing amount of research with it being

The BWC does not prohibit research on defenses against biological weapons where a number of countries, including the USA and its major allies, have continued to do. Indonesia signed the BWC in 1972 and signed the ratification in 1992.

In developed countries such as the USA, Europe, Canada, China, and Singapore, select agents have been defined well, but most of the developing countries including Indonesia do not have it yet [12–16]. Resources of biological agents in developing countries are very significant; thus with the presence of various biological agents and toxins, it can cause a real threat. Some countries can refer to the biological agent list of the US CDC, but this is not a universal list because it may contain some preferences to the US national interest. Developing countries should evaluate characteristics of each biological agent and threats faced, existing biodefense capabilities based on its specific regional conditions. The CDCs of developing country play an important role in this process and cooperate with other related departments and organizations [17]. Although some US organizations had facilitated discussion with relevant Indonesian institution and initiate list of select agents but the list could not be defined yet. Indonesian Ministry of Agriculture has "red microorganisms," where the usage and distribution must be limited to certain laboratories; however, it is not a standard practice for others. Nowadays, there is no select agent list in Indonesia. Controlling the work of using these pathogens and high pathogenic organisms has been performed by each institution individually. Most of laboratories do not have the awareness about the importance to limit the usage of select agents. Furthermore, Indonesia also does not have risk group category criterion. WHO or CDC criterions were followed, which sometimes may not be suitable with local

*DOI: http://dx.doi.org/10.5772/intechopen.90050*

condition (**Table 1**).

workers [21].

#### **Table 1.**

*Comparison of biological agent category criterion based on biosafety.*

*Nurturing Responsible Future Generation of Scientists: Focus on Maintaining International… DOI: http://dx.doi.org/10.5772/intechopen.90050*

The BWC does not prohibit research on defenses against biological weapons where a number of countries, including the USA and its major allies, have continued to do. Indonesia signed the BWC in 1972 and signed the ratification in 1992. Currently, there are 183 countries that have ratified BWC [11].

In developed countries such as the USA, Europe, Canada, China, and Singapore, select agents have been defined well, but most of the developing countries including Indonesia do not have it yet [12–16]. Resources of biological agents in developing countries are very significant; thus with the presence of various biological agents and toxins, it can cause a real threat. Some countries can refer to the biological agent list of the US CDC, but this is not a universal list because it may contain some preferences to the US national interest. Developing countries should evaluate characteristics of each biological agent and threats faced, existing biodefense capabilities based on its specific regional conditions. The CDCs of developing country play an important role in this process and cooperate with other related departments and organizations [17]. Although some US organizations had facilitated discussion with relevant Indonesian institution and initiate list of select agents but the list could not be defined yet. Indonesian Ministry of Agriculture has "red microorganisms," where the usage and distribution must be limited to certain laboratories; however, it is not a standard practice for others. Nowadays, there is no select agent list in Indonesia. Controlling the work of using these pathogens and high pathogenic organisms has been performed by each institution individually. Most of laboratories do not have the awareness about the importance to limit the usage of select agents. Furthermore, Indonesia also does not have risk group category criterion. WHO or CDC criterions were followed, which sometimes may not be suitable with local condition (**Table 1**).

### **4. Emerging and reemerging infectious diseases**

Other important subjects are emerging and reemerging infectious diseases, which could pose a major threat to global public health. On the other hand, these subjects also attract many scientists to obtain good publications and funding. Despite of all efforts in biorisk management, unfortunately the handling of pathogenic viruses remains a likely source of infection, and mortality, among laboratory workers [21].

Accidental infections of workers in hospitals or research laboratories are an emerging threat mainly due to the increasing amount of research with it being

**Figure 1.** *Hepatitis and Ebola virus.*

*Contemporary Developments and Perspectives in International Health Security - Volume 1*

lactic, protective or other peaceful purposes;

ins for hostile purposes or in armed conflict."

1 Well-characterized agents are likely not cause human or animal disease.

2 Agents cause human or animal disease but unlikely to be a serious hazard to laboratory workers, the community, the livestock, or the environment. Effective treatment and preventive measure are available.

3 Agents usually cause serious human or animal disease but do not spread from one individual to another. Effective treatment and preventive measures are available.

4 Agents usually cause serious human or animal disease. They can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.

Article I of the BWC states that "Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or

1.Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophy-

2.Weapons, equipment or means of delivery designed to use such agents or tox-

Agents are unlikely cause human disease.

Agents can cause human disease and might be a hazard to workers. It is unlikely to spread to the community. Effective prophylaxis or treatment is usually available.

Agents can cause severe disease and pose a serious hazard to workers. It may spread to community, but effective prophylaxis or treatment is usually available.

Agents cause severe human disease and pose a serious hazard to workers. Risk of spreading to community is high. Effective prophylaxis or treatment is usually not available.

Agents do not cause human or animal disease under normal circumstances.

Agents cause human or animal disease under normal circumstances but do not pose a serious hazard to people, animals, or the environment, and the risk of transmission is limited. Laboratoryassociated infection rarely causes serious illness with effective treatment and prevention.

Agents can cause serious human or animal disease. It is relatively easy to spread between people, animals and people, among animals, directly or indirectly.

Agents can cause very serious disease in humans and animals, including biological agents that have not been found in China.

**Group WHO [18] NIH [19] EU [13] China [20]**

Agents are not associated with disease in healthy adult humans.

Agents are associated with human disease, which is rarely serious. Effective treatment and preventive measure are often available.

Agents are associated with serious or lethal human disease. Preventive or therapeutic interventions may be available. Risk of spreading to individual is high but to community

is low.

*Comparison of biological agent category criterion based on biosafety.*

Agents likely cause serious or lethal human disease. Preventive or therapeutic interventions are not usually available. Risk of spreading to individual and to community is high.

**184**

**Table 1.**

retain:

carried out involving the Risk Group 3 or 4 [22]. Infections due to the blood borne emerging viruses such as hepatitis C and HIV are the commonest diagnosed viral infections [23]. Laboratory-acquired infection by other emerging viruses such as SARS, Marburg, dengue, vaccinia, Crimean-Congo hemorrhagic fever, Western equine encephalitis, West Nile virus, and Zika has also been reported [24–30].

A strict biorisk assessment should be applied prior to experiments. A sufficient mitigation should be assessed by biosafety officer and Biosafety committee. Unfortunately, only some institutions in Indonesia have Institutional Biosafety Committee and do not have National Biosafety Committee yet. Currently, assessment was performed together, and decision was made based on available mitigation in the laboratory (**Figure 1**).

### **5. Emerging technologies**

Rapid progress of technologies does not only exclusively belong to developed countries nowadays but also spread out to developing countries including Indonesia. Life sciences such a molecular biology, bioengineering, genetic engineering, bioinformatics, and synthetic biology could not be more important nowadays since it plays a pivot role in developing translational medicines and biotechnologies. There are many Indonesian universities and emerging translational medical centers that had declared themselves as research centers focusing on to bring science from bench to bedside. Also, many biotechnology centers provide sources for livestock, pharmacy, cosmetics, industry, and many more. They always try to bring experiments to applications.

On the other hand, the development in life science is no longer obtained exclusively through formal educations but could also be acquired from powerful informal sources such as Internet and social network. Without a proper guidance, biosafety, biosecurity, and dual use issues can become a major risk in human life itself. It could be said that biosafety focuses on procedures and techniques to prevent an accidental or unintentional release of bioagents, and biosecurity focuses more on accountability measurements and procedures to protect bioagents from unauthorized access, misused, thievery act of an intentional release [9, 31, 32]. Dual use according to the US Government is "a life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security." The US Government's oversight of DURC is aimed at preserving the benefits of life science research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. Whereas WHO's definition is "life sciences research that is intended for benefit, but which might easily be misapplied to do harm."

During this time, we also met with students whom very interested in participating on International Genetically Engineered Machine (IGEM), where Indonesia is an active participant since 2013. On one of IGEM project on TBC diagnostic system called "Blue Ivy Project," it brought us to important realization regarding dealing with the amplification of risk in growing cultures and biofilm where rigorous SOPs during works were required to satisfy its biosafety and biosecurity aspect of this project (**Figure 2**) [33].

Challenges in biosafety and biosecurity became more complicated year by year such as "BaContraception Project" to design contraception by using *Bacillus subtilis 168a* and *Escherichia coli BL21* to express SboA—the spermicidal protein and

**187**

*Nurturing Responsible Future Generation of Scientists: Focus on Maintaining International…*

ndoA—the suicide protein, where researchers were exposed to risk of sterility. The lessons learnt from this project were "who create risk will be the responsible person to manage the risk" and realization of no official bodies in Indonesia handling

In the next project, the Hi Vax project, we knew that Indonesia got attention from the IGEM board as we got information from FBI during its workshop in Jakarta. They would like to make us aware that technologies are progressing fast in Indonesia and urge a control going along it to not cause harm and threats. Hi Vax project is a project to make HIV DNA Vaccine. Basically, they are capable of making the HIV proteins with this system. It is why FBI emphasized this issue to all stakeholders in Indonesia to have concerns about the science progress in Indonesia and think about the risk particularly dual use research of concerns along the progress of technologies. In addition, in the recent IGEM project which working with the synthetic toxin of Diphtheria, team started to establish carefully the risk assessment, so they are capable of analyzing the possibility of dual use research and communicat-

Based on our experiment, we realize the urgent of need of National Biosafety Committee or at least Institutional Biosafety Review Board. But, how many lectures or researchers have concern about this? Whereas many new emerging technologies are coming with fast progressing to arrive in the border of ethical problems and of course, the biosafety, biosecurity, and dual use research of concern. Recombinant protein, Genetically Modified Organisms, induced-Pluripotent Stem Cell (iPS), Gain of Function (GoF), and CRISPR (clusters of regularly interspaced short palindromic repeats) are now coming and become a common methods at life science laboratories. In addition, DIY-bio (Do it Your self Biology) is omnipresent at the same time of the emerging of biotechnology program and biotechnology start up. They must be equipped with a sufficient Biorisk Management. Recombinant protein is a technology to produce protein made based on DNA recombinant that has been cloned in system that supports expression of the gene. Modification of gene by using recombinant technology leads to the expression of a mutant protein, over expression or suppress expression. Gain of Function (GoF) is a research that involves experimentation that aims or is expected to (and/or, perhaps, actually does) increase the transmissibility and/or virulence of pathogens. The aim of GOF research is to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. GOF research (GOFR) can pose risks regarding biosecurity and biosafety. Nowadays, new technologies that become a star are CRISPR and iPS. CRISPR or CRISPR Cas 9 system allows genetic material to be added, removed, or altered at particular locations in the genome, whereas iPS allows whatever cells in the body to be reprogram into

*DOI: http://dx.doi.org/10.5772/intechopen.90050*

synthetic biology domain [34].

*IGEM project in University of Indonesia.*

**Figure 2.**

ing it to IGEM's Biosafety and Biosecurity Board [35].

*Nurturing Responsible Future Generation of Scientists: Focus on Maintaining International… DOI: http://dx.doi.org/10.5772/intechopen.90050*

**Figure 2.** *IGEM project in University of Indonesia.*

*Contemporary Developments and Perspectives in International Health Security - Volume 1*

in the laboratory (**Figure 1**).

**5. Emerging technologies**

ments to applications.

carried out involving the Risk Group 3 or 4 [22]. Infections due to the blood borne emerging viruses such as hepatitis C and HIV are the commonest diagnosed viral infections [23]. Laboratory-acquired infection by other emerging viruses such as SARS, Marburg, dengue, vaccinia, Crimean-Congo hemorrhagic fever, Western equine encephalitis, West Nile virus, and Zika has also been reported [24–30]. A strict biorisk assessment should be applied prior to experiments. A sufficient mitigation should be assessed by biosafety officer and Biosafety committee. Unfortunately, only some institutions in Indonesia have Institutional Biosafety Committee and do not have National Biosafety Committee yet. Currently, assessment was performed together, and decision was made based on available mitigation

Rapid progress of technologies does not only exclusively belong to developed countries nowadays but also spread out to developing countries including Indonesia. Life sciences such a molecular biology, bioengineering, genetic engineering, bioinformatics, and synthetic biology could not be more important nowadays since it plays a pivot role in developing translational medicines and biotechnologies. There are many Indonesian universities and emerging translational medical centers that had declared themselves as research centers focusing on to bring science from bench to bedside. Also, many biotechnology centers provide sources for livestock, pharmacy, cosmetics, industry, and many more. They always try to bring experi-

On the other hand, the development in life science is no longer obtained exclusively through formal educations but could also be acquired from powerful informal sources such as Internet and social network. Without a proper guidance, biosafety, biosecurity, and dual use issues can become a major risk in human life itself. It could be said that biosafety focuses on procedures and techniques to prevent an accidental or unintentional release of bioagents, and biosecurity focuses more on accountability measurements and procedures to protect bioagents from unauthorized access, misused, thievery act of an intentional release [9, 31, 32]. Dual use according to the US Government is "a life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security." The US Government's oversight of DURC is aimed at preserving the benefits of life science research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. Whereas WHO's definition is "life sciences research that is intended for benefit, but which might easily be misapplied

During this time, we also met with students whom very interested in participating on International Genetically Engineered Machine (IGEM), where Indonesia is an active participant since 2013. On one of IGEM project on TBC diagnostic system called "Blue Ivy Project," it brought us to important realization regarding dealing with the amplification of risk in growing cultures and biofilm where rigorous SOPs during works were required to satisfy its biosafety and biosecurity aspect of this

Challenges in biosafety and biosecurity became more complicated year by year such as "BaContraception Project" to design contraception by using *Bacillus subtilis 168a* and *Escherichia coli BL21* to express SboA—the spermicidal protein and

**186**

to do harm."

project (**Figure 2**) [33].

ndoA—the suicide protein, where researchers were exposed to risk of sterility. The lessons learnt from this project were "who create risk will be the responsible person to manage the risk" and realization of no official bodies in Indonesia handling synthetic biology domain [34].

In the next project, the Hi Vax project, we knew that Indonesia got attention from the IGEM board as we got information from FBI during its workshop in Jakarta. They would like to make us aware that technologies are progressing fast in Indonesia and urge a control going along it to not cause harm and threats. Hi Vax project is a project to make HIV DNA Vaccine. Basically, they are capable of making the HIV proteins with this system. It is why FBI emphasized this issue to all stakeholders in Indonesia to have concerns about the science progress in Indonesia and think about the risk particularly dual use research of concerns along the progress of technologies. In addition, in the recent IGEM project which working with the synthetic toxin of Diphtheria, team started to establish carefully the risk assessment, so they are capable of analyzing the possibility of dual use research and communicating it to IGEM's Biosafety and Biosecurity Board [35].

Based on our experiment, we realize the urgent of need of National Biosafety Committee or at least Institutional Biosafety Review Board. But, how many lectures or researchers have concern about this? Whereas many new emerging technologies are coming with fast progressing to arrive in the border of ethical problems and of course, the biosafety, biosecurity, and dual use research of concern. Recombinant protein, Genetically Modified Organisms, induced-Pluripotent Stem Cell (iPS), Gain of Function (GoF), and CRISPR (clusters of regularly interspaced short palindromic repeats) are now coming and become a common methods at life science laboratories. In addition, DIY-bio (Do it Your self Biology) is omnipresent at the same time of the emerging of biotechnology program and biotechnology start up. They must be equipped with a sufficient Biorisk Management. Recombinant protein is a technology to produce protein made based on DNA recombinant that has been cloned in system that supports expression of the gene. Modification of gene by using recombinant technology leads to the expression of a mutant protein, over expression or suppress expression. Gain of Function (GoF) is a research that involves experimentation that aims or is expected to (and/or, perhaps, actually does) increase the transmissibility and/or virulence of pathogens. The aim of GOF research is to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. GOF research (GOFR) can pose risks regarding biosecurity and biosafety. Nowadays, new technologies that become a star are CRISPR and iPS. CRISPR or CRISPR Cas 9 system allows genetic material to be added, removed, or altered at particular locations in the genome, whereas iPS allows whatever cells in the body to be reprogram into

stem cells. These future technologies are expected to resolve many problems in disease therapies, and at the same time, we have to minimize the side effects of these technologies.
