Our project is aimed at building a biosensor for detecting the epinephrine in urine. Nevertheless, the provisions of the law seem unclear. According to administrative provisions  and essays related to such provisions , Chinese government attaches great importance to the following three parts.
Quality of biological product
The quality of one biological product is related to many aspects. As for a biosensor, the most critical part should be the accuracy of the result and the time it can maintain its function. Luckily, we did the first by controlling its density and establishing linkages between its density and illumination value. As for the second one, because our biosensor could be used only once, the time should be that between it is produced and it is used. We solved the problem by developing the freeze-dry preservation method.
Supervision after a product goes to the market
Once a biological product goes to the market, it’s hard to predict what it will become. As for biosensors, it is even harder, since evolution is accompanied any time. We have tried to think of a useful way to acquire further data if it is finally presented to the public. Unfortunately, we haven’t found an effective method.
Adverse reaction assessment
Since our project is building a biosensor, and it won’t get in touch with humans, there’s little possibility that it will cause adverse reactions. Furthermore, we use the most common yeast, Saccharomyces cerevisiae. Also, there’s no toxic or human-made gene introduced. Therefore it’s not likely that they could cause adverse reactions if one touch these yeasts carelessly.
To make sure it can be brought to the public, a risk assessment was done. On advance of Professor Shi’s proposal (See more in “interview” below), we proposed a general biosafety risk assessment. Risk evaluation in China includes those five aspects: manufacturing, preservation, transportation, clinical treatment and immunogenicity . Besides, we looked up to international risk assessments . It stresses these two points: the influence which new genes could give the receptor, the influence it will bring to the environment. On advance of these three databases, we made a risk assessment below.
Manufacturing, preservation and transportation
Manufacturing of biological products includes culturing, fermentation, purification and packing. Each process can influence the final quality of the product. The temperature of culturing, the time of fermentation and the technology used to purify, even a single change will make a difference. Luckily, the microorganism used in our project is Saccharomyces cerevisiae, the most common yeast which has successfully been manufactured.
What should be mostly highlighted in preservation and transportation is whether the biological product lose its function. Since most biological productions rely on their activity, any change among temperature, humidity, oxygen or light may ruin them.
We have successfully found a method to restore the yeast. By preserving yeast in this way, yeast can be stored for three months without losing its function. Also, we are happy to see that dusty yeast in market can keep it active for longer than two years. So we are confident to the preservation and transport procedure.
The Gene We Brought to Yeast
As for gene change in yeast, there’s also not much to worry about. What we have brought into yeast is GPCR, a kind of receptor protein. Moreover, this protein comes from human beings ourselves, which identify epinephrine. Another gene we introduced is Nano-Lantern, a common cAMP triggered protein.
Another thing we must take into account is how we introduce these genes into yeast. As Professor Shi mentioned, the method we used must be “traceless”, which means we can’t change the structure of the protein it expresses. We followed the traditional and common protocol of homologous recombination. It is, as Professor Shi said, a traceless technology. Therefore we don’t need to worry about the gene we introduced into yeast.
The influence on Humans
Based on China’s risk evaluation, the influence on humans should include these two aspects: clinical treatment risk and immunogenicity (Kai X. et al., 2016). Clinical treatment risks include untoward effect under normal dosage, like allergy, and irrelevant dosage, while immunogenicity refers to the ability to stimulate one organism to form specific antibodies, especially allergic ones. Since the biosensor we build can give its result without touching the skin, it’s not likely to trigger an allergic response. In order to avoid irrelevant usage, we made a detailed instruction, and we also developed an app to give guidance.
The influence on Environment
When one gene product is brought to the environment, it’s always the toxin it takes that counts. Nevertheless, in our project, as we have said above, there’s no toxic change for itself, and certainly no for the environment.
Moreover, as Professor Shi pointed out, Chinese government hasn’t published any administration for biological products which specifically aimed at detection. So our project actually doesn’t have such problems.
To know more and get instructions of laws and risk assessments, we interviewed Professor Shi J., an expert of risk assessment and biosafety in School of Bioscience and Biotechnology of SJTU. He gives us many useful advices. Besides, he pointed out several problems we must cover in our experiments.
“China hasn’t set specific rules for biological products which aimed at detecting disease.” He said, “What the government attaches importance to is gene engineering on food and biological agent.” On account of this, there’s actually no administration or law that we could follow. “But as a project which uses active organisms,” he said, “you must make sure you have the ability to deal with it after it is used. It’s illegal to simply let it alone.”
When we asked about risk assessment, he told us there’s not much to worry about. Only when our project becomes into product and is having clinical test will we need to think highly of the risks it may bring. “But of course you cannot do such further,” he smiled.
As for our project, he pointed out that we must control the density of yeast every time we detect the illumination intensity. He thinks the freeze-dry method we used for yeast preservation can solve the problem of both preservation itself and the control of density.
Figure 1. Professor Shi (left) and his workmate (right)
Lab work safety
Before starting any work in the lab, all of our team members should be aware of the safety and security process. When we do some experiments, there’re also some graduated students besides. Anyone who do a certain work for the first time, there must be a team mate who can do it practically standing beside, watching him and giving instructions. For safety education, we specifically focused on emergency rules, waste disposal, cleanliness, and the use of any laboratory apparatuses. This was all done in accordance with the instruction of Shanghai Jiao Tong University Assets Management Bureau, which is responsible for biological safety matter.
 Administrative Provisions of Biological Products. The people's Republic of China National Health and Family Planning Commission . 1993
 Administrative and Issuing Provisions of Biological Products. China Food and Drug Administration. 2004
 Jin Yu, 2014, Development and regulation of biological products in China, Journal of China Pharmaceutical University, 2014, 45(3): 378-382
 Kai Xuefeng, 2016, Risk Evaluation and Risk Management of Biologicals, Chin J Pharmacoepidemiol 2016, Vol.25, No.5
 Cartagena protocol on Biosafety, 1995