Colloidal gold research and development route, production cost analysis!
www.yanshuitech.com
We know that in the new crown, many biologists have abandoned other basic theoretical research with difficult methodologies, and turned to this application field, using their own laboratory facilities to start developing colloidal gold rapid diagnostic products, which was the first for themselves in the early days of entrepreneurship. pot of gold. Colloidal gold rapid diagnostic reagent is one of the most successful products in bio-industrialization in recent years. I have worked in this industry for a relatively long period of time and have had contact with many colleagues. Here I will write a little about my feelings about this industry. If my personal opinion is wrong, I hope to correct it.
The technical threshold of colloidal gold is relatively low, which can explain the advantages in terms of research and development cost time and profit generation. The essence of colloidal gold is the immune response. To study this project, you need to have certain knowledge of immunology. At the same time, the core issue is in the labeling technology. Due to the different raw materials used by each company, there are bound to be big differences in the specific labeling methods. I want to know the specific technical issues. You can refer to the transfer of a complete set of colloidal gold detection technology platform, limited time and limited price! Here I only elaborate on my planning thinking on technical research and production. If you receive a new project, how to start, how to arrange time and manpower? How to transfer to production after R&D is completed? How can costs be reduced? First of all, I want to explain that the core idea of my planning is to imitate! First imitate the same or similar products and enterprises, then innovate on this basis, and finally obtain profits.
1. R&D phase planning
For project approval, each company has its own market. If you confirm that the market demand is strong, you can consider project approval. If you want to expand, you must also consider patent issues, and check relevant research literature at the same time, but pay attention to some early investment budgets. , especially the approval expenses (explicit and hidden, it is best to find an approval company to deal with, the price is cheap and efficient, and sometimes the product can be obtained before the product is developed) / high loss costs in the early stage of production, use According to the equipment purchase budget, the quality of slivers made by different equipment will also be different, especially in the initial stage of research and development, it is easy to be seriously interfered by equipment factors. After receiving the project start order, purchase the same product or similar principle on the market. Products, for analysis and indicator testing. One technician, one week, the result is a detailed analysis report of technical indicators. At the same time, another person is entrusted to search for suppliers of raw materials, including antigens, antibodies, membranes and other materials, and obtain small samples, which will be completed within two weeks. (If you have never been exposed to this technology, it is recommended to do some simple early pregnancy test paper to practice before starting. The technology is very simple and the cost of practice is very low. The time is 3/4 days. The purpose is to quickly become familiar with the technology and obtain perceptual knowledge.)
Next, according to the situation of the analysis report, began to imitate the production of test strips. This depends on the difficulty of your product development to determine a specific time schedule. At the same time, it is necessary to call special personnel to start the research and development of upstream antigens and antibodies. It is best to have experienced masters, or to cooperate with other antigens and antibodies production institutions. In this way, we can obtain preliminary biological raw materials that can be used within 3 months. Finally, use self-produced raw materials instead of purchased raw materials to reduce production costs. At the beginning of research and development, you can consider using a sample gun to directly point the sample on the membrane (purchase of the membrane: S&S buys it from a gene company, millipore’s membrane is sold by his own company, whatman is also sold by whatman, and sartouris is also sold by itself It’s really not easy to buy when the amount of film is not large, because this kind of thing is cheap, and it’s a loss if you sell it in a small amount. You can go to your peers to “borrow” (don’t look for me)) After drying, directly touch gold and add it to be tested Solution, so that a simple reaction can be carried out, and it can be seen whether the antigen and antibody can be combined. This method can make the exploration in the early integration stage much faster.
If it can be combined, adjust the concentration, buffer pH, salt ions, protective proteins, surface active substances, etc. You can refer to the adjustment of the optimal environmental parameters of the paired protein (check from previous academic papers). At this time, there will be a problem, that is, the point at the T line does not form a line, because a device such as a pipette is used, and the solution expands into a point when it is touched, and a special spraying device is needed at this time. With BIO-DOT, the effect is not much to say, 80-90% of the market share (gene company general agent in China). Gold can be sprayed by immersion or by the airjet nozzle on the bio-dot. It depends on the specific experimental results to confirm which method is better. In my experiment, I think it is sprayed well, relatively uniform, and will not cause edge deposition like soaking , the release effect is much better.
When the product has been developed to a certain extent, the line can come out, and the ideal goal is not far away, it is necessary to prepare materials for approval. At present, it is relatively easy to apply for approval of agricultural and animal test strips; human medicine is troublesome. There are two major categories of drugs and medical devices in the classification. Mature products such as early pregnancy are now classified as medical devices, and they need to be submitted for approval for 3 months. More is almost the same, and the other ones are classified as drugs, which normally takes two years, and it takes a little more than a year to find a reporting company. Therefore, it is necessary to determine the cost of post-approval and other expenses before the project starts. In research and development, you can contact suppliers such as membranes and equipment to obtain some technical support. At the same time, we must also pay attention to technical confidentiality.
2. Production stage
There is a running-in time for R&D products to enter production, during which some formula and process adjustments need to be made. It is recommended to use the method of gradually expanding the R&D and production methods in the initial stage. And do a good job of detailed quality records for each step, future inquiries, approvals, etc. will be of great help. However, when the single batch is very large, it is necessary to pay attention to a small adjustment in advance, that is, when there is no problem with the paired antigen or antibody and the reaction conditions, the production can be expanded. And it needs to be tested before assembly. If it is cut into strips, there is no room for recovery. The biggest problem in the production stage is cost. One of the costs is biological raw materials, and the other is the membrane. Biological raw materials refer to antigens and antibodies. This is why I recommend research and development in advance. After successful research and development, very large economic profits can be obtained. The membranes are all imported at present. The situation of the suppliers has been written above and will not be repeated. What needs to be reminded is that the price will vary greatly when the batch is different. Cost estimate: In addition to biological raw materials, the output is 300,000-400,000 per day, and the strip width is 3mm. The cost of a single strip is about RMB0.12. The retail price of the finished product market is RMB3, 5 yuan to RMB30 per strip, of course, in terms of width. It may be added to 4 or 5mm, or a plastic box of one or two cents will be added, and the profit margin will be calculated by itself, ha ha. Because everyone chooses different film suppliers, there may be a difference of a few cents. Everything else is minor.
