On July 21, several scientists published an article published in Trends In Biotechnology in the Cell, reveals the traditional antibody production brought serious harm to animal welfare, and calls for the use of bacteriophages viruses instead of the animal produce antibodies to protect animal welfare. Points out that, although this technique has many advantages compared to conventional patterns of animal production, but was ignored by people. Humanitarian act, not necessarily at the expense of sacrificing productivity. Changing the mindset of the people, and improved technology are equally important.
Harsh reality
Antibodies are the most commonly used biological agents-not only in the field of basic research, they are also widely used in disease diagnosis, treatment and other aspects. Biomedical field type and quantity of the antibody has a lot of needs. For example, the human genome has only 20000-25000 proteins encoded by genes and mRNA shear, post-translational modification, variation of the biological process will produce a lot of protein, proteins to expand more than 10 times. If you want to detect these proteins, it is necessary to use corresponding to the antibody-strong demand has created the developed market-there were over 2 million scientific research antibody products, over more than 300 research antibody suppliers in Europe and alone (see: 2016 global research antibody industry report). It is estimated that the entire antibody-related market size up to more than $ 80 billion of "1".
Traditional methods of antibody production greatly depends on the animal. Animals immunized for antibody production-injected Antigen and adjuvant to stimulate antibody production in the body-and separate goals from ascites antibody (Polyclonal Antibodies) or b lymphoma cells extracted from the kidney, and the fusion of myeloma cells, hybridoma cells formed, then extract the target antibody (monoclonal antibodies).
Around the world, millions of animals are used in antibody production and research and development. According to statistics, United Kingdom in 2013, a total of 9,522 animals were used in antibody production. In the Netherlands, this figure is as high as 25,697 "1". With the progress of civilization and animal welfare by more and more companies are valued by some region of the antibody suppliers against the law and morality, to squeeze profits from animals. In May this year, antibodies against Santa Cruz Biotechnology industry giant was accused of cruelty to animals, by the United States Government's sky-high fines of $ 3.5 million, and Polyclonal Antibody will be banned (see: 2016 first fallen antibodies or giant). Why is Santa Cruz Biotechnology giant antibody? Because this company is only the number of animals used in 2013 and reach 15,648, surpassing the United Kingdom the sum of 1.5 times!
Today, there are still many claims of "animal friendly (animal-friendly)" the traditional antibody production, but in fact is not "friendly"!
A technological breakthrough
Why use animals to make antibodies against it? It is a technical limitation that I?
Over the past 20 years, the true sense of "animal friendly" method for production of antibody in rapid development and has technically mature enough to replace the traditional production of antibodies-immune animals. Have a variety of animal-friendly affinity reagents (animal friendly affinity reagenats, AFA) was successfully developed, and even put into commercial production. Production of these reagents is completely independent from any living donor's immune system, and the ability to replace existing animal immunization techniques, applied in a wide range. AFA is by phage display, Ribosome display or yeast produced in vitro and filter. These products are mainly antibodies,
Points out that using phage display antibodies made in, and not just "looks like antibody" or "similar effects with the antibody", which is actually "original" antibody-they have the identical to the antibodies produced in vivo biological activity in the development, function, and structure, they are unable to distinguish between antibodies and live production. Also, their specificity is excellent than manufacture antibodies in vivo, can effectively avoid the antibodies polymorphisms, and consequently reduce repeatability issues caused by antibodies. Meanwhile, lower their production costs, greater production capacity. Theoretically, you only need to build a phage display Library of good and reasonable screening measures, equivalent to the use of this technique to produce and live production of antibodies. Even quality produce antibodies do not meet the expectations, you can also use various means to improve the specificity of antibodies in vitro affinity, as well as other features. At present, some large-scale comparative studies, such as the Structural Genomics Consortium SH2 Pilot, EU programme Affinity Proteome and the NIH Common Fund Protein Capture Initiatives, indicate that the production of phage display antibody and hybridoma cells without using (monoclonal antibody technology) cases, To create the equivalent of monoclonal antibodies. Market, as well as some more sophisticated non-animal sources of antibodies: AbD and Yumab.
Policy and regulation
Humanitarian and animal protection, has always played an important role in the Western countries. Article cites the EU's animal protection policy for scientific research purposes: the 3Rs principle-an alternative, less refined (replacement, reduction, refinement). From the name, it is not difficult to see the purpose of this regulation is to take advantage of policy regulation, promotion of alternatives to animals in research applications, thus reducing the use of laboratory animals. For example, the Bill provides that "if possible, a technical meeting on the standard method or means (not involving animal use), as an alternative to animal experiments. "In addition, the Bill also States that" If there are other methods can get favorable results recognized by the EU legislation (not involving animal use), so some steps involved animal experiments cannot be executed. "These provisions mean that in each of the Member States of the European Union, animal experiments, including antibody production are subject to government audit and evaluation to ensure that" animals was the only reasonable choice. "
In Europe, it is as an alternative to animal produce antibodies to provide legal support. Phage display method can be used as a perfect substitute for animals, but because of some misunderstanding on the concept, led to the approval authority that the animals produced antibodies are "irreplaceable." Therefore, many antibody manufacturing projects can still be approved, the replacement technology is not given sufficient attention.
A bright future
The first author of the article, visiting scholar, Dr Alison Gray from the University of Nottingham said: "the ultimate goal of scientists in this field, which is entirely replace animals in research and production. However, due to lack of sufficient awareness of these alternative technologies, changes would not be so quick. Using phage display to create more resistance and monoclonal antibody technique, existed as early as 20 years ago. This is a cost-effective technology, enough to replace such a huge amount of experimental animals. In fact, the technology has matured enough to eliminate existing means of animal vaccination. "" 2 "
Therefore, based on the 3Rs principle of the EU, led many scientist Dr Alison Gray by 7 plan of action, used in place of animal production of antibodies-led by the European Union, extending to scientific research institutions and biotechnology industries:
Way to completely replace the use of animals immune to manufacture antibodies, including antibody related products imported, unless it can be proved in some cases AFA cannot be used as a substitute.
An expert working group should be established, and specific courses of action planning using the AFA as an alternative to animal antibodies.
Project to promote the transformation and diffusion of new technologies. This should include the establishment of technology centres, for antibody producers with AFA technical training, to ensure that adequate technical support.
Animal origin antibodies in non-EU areas should be assessed to ensure that the production of these antibodies is in line with EU standards, particularly in the area of animal protection laws weak.
The European Union reference laboratory (EURL), together with its international partners to expand areas of activity will include the production and application of AFA.
Obey the 3Rs principle of EU countries and institutions, as well as cosmetics in accordance with EU regulations, medicine as well as food businesses, should fully support the 3Rs principle, stop antibody related products of animal origin imported.
Animal statistics report issued by the European Commission, should be "animals for antibody production" is classified as a separate category.
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