**1.1 Why metrology for modern biology**

The full scale DNA information obtained from the Human Genome Project has enabled the revolutionary advances in biotechnologies (BT). Information on human genome is equal to a whole blueprint on human body. Although gigantic, such information can be comprehended and handled with the help of modern information technology. With the information, we can fully understand how our bodies are structured and functioning. Consequently, there will be tremendous advances in human health with innovations in modern medicine driven by BT. It is for sure that mankind will enjoy a healthy and extended life term in a way they never grasped before.

The bright sides of the advanced BT come only with dark sides. It is anticipated that disastrous mishaps could occur as we don't have experiences on such new products of BT. The great outcomes of modern BT can be enjoyed only with meticulous assurance on their safety and efficacy. As those directly touch the quality of life, they could be expensive ones that people have to pay over the financial burdens. Then, the fidelity of such claims will have grave importance to many customers. More important, it can greatly jeopardize lives unless all possible safety concerns have been exhaustively confirmed. Therefore, BT products are subject to extensive testing for quality control (QC) as well as for quality assurance (QA). An unavoidable question here is if the results of such testing are believable. There are numerous formats of bioassays that can be applicable to such testing. Some of those assays might be applied to critical tests for QC and QA without appropriate method validation. Consequently, different results can be produced at different laboratories, which will then create conflicts and disbelief among stake holders. Even worse, some assays that lack analytical reliability can be used to blur the undesirable characteristics of properties of some products.

There have been a number of prominent incidents that insufficient or inadequate testing for QC of biological products greatly risked public health. Among them, "tainted heparin" caused at least 80 deaths. Heparin is used as a blood thinner against formation of blood clotting during surgery or dialysis. The FDA's investigation concluded that heparin problem was due to contaminated raw stock from China with which Boxter Healthcare produced a prevailing portion of world heparin supply. Tight and adequate testing to detect such fatal contaminants before sales would easily avoid such incidents and save many lives. Similar tragedy occurred with dairy products as baby meal. As a greedy adulteration of dairy products, melamine was added to milk products to fake high protein content in nitrogen analysis. At least 50 thousand babies were harmed by the melamine in their meal. This incident was also a prominent example of public health risked by insufficient or inadequate testing for quality control of biological products. If QC of dairy products was performed by a method capable of distinguishing real proteins and a nitrogen-rich toxic chemical, such disaster could be easily avoided.

Considering even more complicated products of modern BT, the need for rigorousness of such testing is out of question. There are and will be numerous new products from nucleic acids, proteins, and cells that are highly complex in structures and activities. Consequently, a number of novel analytical approaches are being developed to characterize and quantify such complex biological entities. However, what would be the standards for adequateness of such assessments? Proper answers to the question above should be attained before fullscale industrialization of modern biotechnology and eventually their routine commercial applications. In other areas undergoing earlier industrialization, the support of metrology was critical. The similar or even greater support of metrology is needed for industrialization of biotechnologies. In this area, inaccuracy is more critical, and uncertainty in measurement is much greater. Therefore, metrology for biology should be regarded as a critically important area of modern metrology.
