What are Biopharmaceuticals?

Biomedicine refers to the use of research results in microbiology, biology, medicine, biochemistry, etc., from organisms, biological tissues, cells, organs, body fluids, etc. A type of products used for prevention, treatment and diagnosis, which is made by comprehensively using scientific principles and methods of microbiology, chemistry, biochemistry, biotechnology, and pharmacy.

bio-pharmacy

(Pharmaceutical Technology)

Biopharmaceuticals are methods that use living organisms to produce drugs. Such as the use of transgenic corn to produce human antibodies, transgenic bovine mammary gland expressing human 1 antitrypsin and so on. The biopharmaceutical industry has a bright future. Half of the pharmaceutical products in the world are biosynthesized. It will be widely used to treat cancer, AIDS, coronary heart disease, anemia, dysplasia, diabetes and other diseases. The vast majority of antibiotics that have been used in medicine come from microorganisms, such as erythromycin, jiemycin, and penicillin, streptomycin, and gentamicin for injection. The number of people engaged in the research, development, production and management of the biotechnology industry in China is only one-fourth that of the United States. There is a serious shortage of talents engaged in the research and development of biomedical products, which has become a bottleneck restricting the development of China's biomedical industry.

The development of the domestic biopharmaceutical industry has the characteristics of small scale, low concentration, and rapid growth.

From 2006 to 2010, the scale of China's biopharmaceutical industry increased by 272%. Although the sales of China's biopharmaceutical industry have increased sharply, it is only close to the sales of the American biochemical company Amgen. The annual sales of five listed companies of Hualan Biological, Tiantan Biological, Kehua Biological, Shuanglu Pharmaceutical, and Da'an Gene only accounted for about 4% of the market share. There is an imbalance in the production capacity structure of China's biopharmaceutical companies, insufficient high-end drug capacity, and excess low-end drug capacity. For example, more than half of the vaccines produced in China are vaccines for the prevention of common diseases such as polio and measles. There is no development of cutting-edge cancers and AIDS vaccines. At present, domestic companies in the biopharmaceutical industry have relatively weak independent product research and development capabilities. Mainly pharmaceuticals and raw materials, the competitiveness is poor. Only about 5 percent of the original biopharmaceuticals that have been approved for marketing in China are generic drugs. In the domestic biopharmaceutical industry, only a small number of biopharmaceutical plants are close to the international level, and most biopharmaceutical plants have relatively little R & D investment.

The vitamins we eat,

Human immune RNA

3. Restructuring to promote redness

In the past 20 years, modern biotechnology, represented by genetic engineering, cell engineering, and enzyme engineering, has developed rapidly. Major technologies such as the Human Genome Project have made breakthroughs. Modern biotechnology has been widely used in medical treatment. The process of industrialization of biomedicine has accelerated significantly. The industrialization of world pharmaceutical biotechnology in the 21st century is gradually entering the investment harvest period.

Guo Fanli, a researcher in the pharmaceutical industry, pointed out that in China, the biopharmaceutical industry is also facing a good development environment. First of all, the policy forms a favorable support for the development of the industry. The pharmaceutical industry itself is an industry susceptible to policies. A positive policy environment can accelerate the development of the industry. Governments at all levels in China have gradually increased their support for the development of the biopharmaceutical industry. Secondly, the improvement of medical and health standards is conducive to the development of the biopharmaceutical industry. With the development of China's economy and the improvement of medical and health standards, more and more people have the ability to pay for relatively high-priced medicines.

Up to now, China has taken biopharmaceuticals as a pillar industry for high-tech and key construction industries for economic development to develop. In some economically developed or technologically advanced regions, a number of national-level biopharmaceutical industrial bases have been established. , Jiangsu, Liaoning, Hubei, Hunan and other places, a number of key biopharmaceutical technology enterprises have risen rapidly. Under the influence of this policy, China s biopharmaceutical research and development with independent intellectual property rights will achieve significant results in the future. Entering the international market, the gap with international biopharmaceutical companies will be further reduced.

In general, the development prospects of China's biomedical industry are promising, and it will maintain a good growth momentum of steady growth in the next 5-10 years. In addition, China

Biological pharmaceutical pure water equipment consists of multi-media filters, activated carbon filters, softened water filters, precision filters. The main machine is mainly composed of high-pressure pump, membrane shell, imported reverse osmosis membrane module, on-line instrumentation, and control electronics. The post-processing part consists of a polishing pure system, a sterilization line sterilizer, and a 0.22 microporous filter.

Biological pharmaceutical ultra-pure water equipment process:

1. Raw water-raw water pressure pump-multi-media filter-activated carbon filter-water softener-precision filter-first-stage reverse osmosis equipment-intermediate water tank-intermediate water pump-ion exchanger-purified water tank-pure water pump-ultraviolet sterilizer -Microporous filter-water point;

2. Raw water-raw water pressure pump-multi-media filter-activated carbon filter-water softener-precision filter-first stage reverse osmosis-pH adjustment-intermediate water tank-second stage reverse osmosis-purified water tank-pure water pump- Ultraviolet sterilizer-microporous filter-disinfection-water point;

3. Raw water-raw water pressure pump-multi-media filter-activated carbon filter-water softener-precision filter-first-stage reverse osmosis machine ------- intermediate water tank-intermediate water pump-EDI system-purified water tank-pure Water pump-ultraviolet sterilizer-microporous filter-sterilization-water point;

4. Raw water-raw water pressure pump-multi-media filter-activated carbon filter-water softener-precision filter --- first stage reverse osmosis-pH adjustment-intermediate water tank-second stage reverse osmosis-RO water tank- RO water pump --- TOC decomposer ---- EDI system--purified water tank-pure water pump --- nuclear polishing and purification-ultraviolet sterilizer-microporous filter-sterilization-water point.

Features of bio-pharmaceutical ultra-pure water equipment:

All pre-treatments use fully automatic filtering devices.

The RO host system uses a fully automatic control device, with functions such as automatic water production, automatic flushing, shutdown of raw water shortage, shutdown of full water tank, high pressure and low pressure alarm.

RO host is equipped with online display devices: such as pressure gauge, conductivity meter, flow meter, etc. And can achieve online monitoring.

The water system pump uses the South pump (SUS304 material), and the RO membrane adopts the imported brand (American Hyde Energy).

The polishing mixed bed adopts imported resin, and the water resistivity of the system is stable above 15 megohms (conductivity is less than 0.06 s / cm).

The pure water tank is made of SUS304 sanitary material (internal and external polishing), and it is also equipped with a respirator and a spray ball.

The system has a compact structure, small footprint, and effective space saving.

The system has low energy consumption and effectively saves energy.

The system operates reliably, the water supply pipeline is closed, and the effluent water quality is stable.

Application fields of bio-pharmaceutical ultra-pure water equipment:

1. Production of large infusions, injections, oral solutions and other preparations

2. Extraction and washing of raw materials, injection, capsule production

3. Production of eye drops and care solutions

4. Sterile water in hospital hemodialysis room, biochemical analysis room, operating room

5, multi-effect distilled water machine raw water, bottle washing water

6, cosmetic process water, washing supplies water

7, biochemical pharmaceutical products, diagnostic reagents

Biopharmaceutical ultra-pure water equipment effluent standards:

China 2010 Pharmacopoeia Purified Water Standard; Meets GMP standards.

"Chinese Pharmacopoeia 2010 Purified Water Standard"

1. Properties: colorless, odorless, odorless clear liquid.

2. pH: Take 10 drops of this product plus 2 drops of methyl red indicator liquid, which should not be red, take another 10 ml, add 5 drops of bromothymol blue indicator liquid, and do not show blue color.

3. Nitrate: Take 5ML of this product and place it in a test tube, cool in an ice bath, add 10% potassium chloride solution 0.4ML and 0.1% diphenylamine sulfuric acid solution 0.1ML, shake well. Slowly add 5ml of sulfuric acid, shake well, and place the test tube in a 50-degree water bath for 15 minutes. The blue color produced by the solution and the standard nitrate solution (take 0.163g of potassium nitrate, add water to dissolve and dilute to 100ML, shake to obtain Each 1ML is equivalent to 1ugNO3) 0.3ML. Add nitrate-free water 4.7ML, the color after treatment with the same method must not be darker (0.000006%).

4. Nitrite: Take 10ML of this product and place it in Nessler tube, add 1ml of p-aminobenzenesulfonamide dilute hydrochloric acid solution (1-100) and 1ml of naphthylethylamine hydrochloride solution (001-100), the resulting pink color Dissolve with standard nitrite solution (take 0.750g of sodium nitrite (calculated as dry product) with water, dilute to 100ML, take 1M with precise amount, dilute with water to 100ML, shake well. Then take 1M with precise amount and dilute with water to 50ML , Shake well, have 0.2ML (every 1ML is equivalent to 1ugNO2), add 9.8ML of nitrite-free water, and compare the color after treating with the same method, it must not be darker (0.000002%).

5. Ammonia: Take 50ML of this product and 2ML of alkaline potassium iodide test solution, leave it for 15 minutes, and add color. Compared with 2ML of ammonium chloride solution, 48ML of ammonia-free distilled water and 2ML of alkaline potassium mercury iodide test solution, it must not be deeper (0.00003%).

6. Electrical conductivity: It should meet the requirements of not more than 5.1 s / cm at 25 degrees.

7. Total organic carbon: It should not exceed 0.5mg / L.

8. Easy oxide: Take this product 100ML, add dilute sulfuric acid 10ML, and boil, add potassium permanganate solution (C (1 / 5KMnO4) = 0.1mol / L,) 0.10ML and boil for 10 minutes, the pink color must not be completely disappear. Note: Total organic carbon and easy oxide can be selected as one of the two options.

9. Non-volatile matter: Take 100ML of this product, place it in a weighing dish with a fixed weight, evaporate to dryness on a water bath and dry to constant weight at 105 ° C, and the residue should not exceed 1mg.

10. Heavy metals: Take 50ML of this product, add 18.5ML of water, evaporate to 20ML, and let cool. Add 2ml of acetate buffer solution (PH3.5) and water to 25ML, and add 2ml of thioacetamide test solution. Shake well and leave it for 2 minutes. Compared with the standard lead solution 1.5ML and water 18.5ML, the color should not be darker (0.00003%).

11. Microbial limit: Take this product, and use the membrane filtration method to check it according to law. The total number of bacteria, mold and yeast should not exceed 100 per 1ML.