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Patent protection of biomedical innovation projects possible role of TRIZ and ARIZ in the formation of this protective strategy (continued, part five)

Andrew (Gabriel) Livshits, Jaroslav Vashchuk

Finally, the practice of patenting genes and other genetic material inevitably raises the issue of inventor rites . To employees Myriad Genetics could be isolated and purified genes BRCA1 and BRCA2, thousands of scientists in institutes and universities in different countries for many years for the state money studies the emergence and growth of tumors, the role of these genes in the development of breast cancer, as well as the general principles of separation and with genes. However, any invention made in a vacuum, and uses the previous experience in the relevant field, and much more interesting to figure out how to dispose of the company's scientific data that have been received over the years of exclusive "use" patented genes.
Supporters of patents believe that these documents incorrectly viewed as something that limits the development of a product. "This view is characteristic of Russia, but in general, the situation is rather the reverse: patents with intellectual property rights (and yourself at the same time are a commodity) and stimulate funding and applied research companies that have patents or buy the right to use them "- says Severin. "Probably, the patenting in general - is an important mechanism of regulation of the legal property relations - agrees Radchuk. - And patented technology can be: in any case, now it is unlikely to serve as a brake. Contrary, been developed by biotechnology and open a lot more valuable and interesting than to the market. Personally, I am opposed to the patenting of genetic material. Its still study and learn. sooner to stop the patenting of genes, the better for us all, no matter how the tricks lawyers in the language. "
Obviously, with the development of molecular biological techniques and study the role of heredity in the development of diseases of the patented genes, mutations, and methods of analysis will only grow. Parallel will increase and the number of malcontents who believe that mass patenting of biological objects will seriously slow down the investigation. And, I think, the most high-profile battles ahead.

Consider several new technological developments in the field of bio-medical product innovation:
Computer assisted bio-technology
Robotics for rehabilitation
General bioengineering
Computer - based medical systems
Bio-medical robotics and Bio-mechatronics
All these areas and include a lot of inventions, in aggregate form, with each group, holistic integrative solution
This decision is usually individually for each direction is all that determines the so-called inventor - nature and all the technical details that allow them to attribute inventors shaping the evolution of bio-medical technology
As an example, here is one of those complex processes to transform the known biological object - chicken eggs in the same well-known biological products produced by the way, and other technologies, and other source materials:
... Of storage capacity (stage d) egg melange / egg white / egg yolk with a pump converted to a turbulent heater for pasteurization. Pasteurization is carried out at 64-66 C for 2-4 min. This ensures the inactivation of most bacteria, such as E. coli and Salmonella.
You can hold the liquid pasteurized egg mixture / egg white with hydrogen peroxide at low temperature 7-13 C to avoid possible changes in the composition of the mixture of egg / egg white to the temperature. 1.3L about 35% hydrogen peroxide for 1 ton of liquid egg mixture slowly added with continuous stirring. After a 20min delay introduced into the reactor 100-150ml enzyme Catalase (C641L), to remove residual hydrogen peroxide. Pasteurisation of egg protein, hydrogen peroxide is introduced at a rate of 3ml/min for 10-16 hours.
g) spray drying.
Warm liquid product from step pasteurization using a pump enters the tank from which the pump by creating high pressure fluid in the form of a mist enters the spray dryer. Inlet air temperature varies +150- +200 C, and the output +55- 65 C. The resulting powder is deposited on the walls of the dryer konicheskh and collected in the bottom of the dryer. After cooling to room temperature, the powder is packaged. The dried product has a moisture content of 2-4% and the density of 0.3-0.35 g/cm3.
Decreasing the amount of sugar in the egg powder / protein.
Egg protein powder and the pasteurization and drying change its color to brown. This is explained by the reaction between glucose and protein at high temperatures - Maillard reaction.
To reduce the sugar content in the egg powder / protein recommended enzyme Glucose oxidase (G168L) 100-150ml per 1 ton of liquid product. System enzyme / coenzyme - Glucose oxidase / Catalase effectively turns glucose eggs (egg melazh or egg white) to the acid (gluconic acid).
Obessaharivanie egg white with Propionibacterium shermanii (+37 C, 24 h) leads to the complete removal of glucose, carbohydrates constitutes the bulk of the protein enrichment of egg protein and vitamin B12 konseviruyuschim agent propionate.
To significantly reduce the sugar content in the egg powder / egg whites can be used pre-fermentation liquid yachnogo raw material using baker's yeast. Glucose in the egg white is sharply reduced in the presence of 0.1% Saccharomyces cerevisiae - baker's yeast extract.
Fermentation of whole eggs in the presence of 0.2-0.4% wet baker's yeast at 22-23 C there for 2-4 hours. Centrifugation-free sugar liquid removes yeast cells and improves the smell of the product. Acidification to pH egg melange than 6.0 increases the rate of fermentation. The optimum fermentation temperature 30 C, 0.07-0.15% of yeast and fermentation time 2-3 hours. The fermentation process is a major innovation in the transition process, and is the basic invention, which combines and so-called invention of nature and original inventions by inventors
What remains after the egg powder? - Water and eggshell.
Egg powder is an alternative to fresh eggs, both in terms of ease of use and storage. The powder is mixed with water to form a liquid eggs, which can then be used as fresh eggs. 1 kg of egg powder can be prepared 4 kg of liquid eggs.
Egg powder can be used in most egg dishes or recipes that require the use of eggs.
Egg powder could be used in a mixture with other powders of organic and inorganic origin.
Refining involves egg powder, for starters, his transfer to the solution, and after the cleaning process - again dehydrated. It is impractical, both from an economic point of view and from the point of view of the possibility of losing more of the quality and quantity of the product. Much more effective to clean (from sugar - glucose) prior to spray drying.

2. Egg production of oil.
The process involves the use of volatile organic solvents and, therefore, all the equipment and communication must be made of chemically resistant materials (stainless steel, enamel, glass), and equipment - to be explosion-proof and fire-proof design.
This process is used:
1. Two reactors with agitators R1 and R2
2. Three tanks for the three solvents E1, E2 and E3, and four containers for the collection and storage of finished products
3. Three capacitors
4. Flow centrifuge
5. Four evaporator I1, I2, I3 and I4
6. Vacuum rotary evaporator
7. Three intermediate ekosti for three secondary solvent S1, S2 and S3
8. System for the dehydration of solvents
9. Pumps for solvents, handling of extracts and products
10. System for packaging and products upaovki
11. Refrigerators for storage of oil and egg lecithin

Facilities for the production and storage areas should be equipped with ventilation and conform to the standards for food production.

The process of separating the contents of the eggs into individual components is a series of periodic, the process of extraction agents, filtration / centrifugation of solutions and solvent evaporation, held in closed containers. Extraction is carried out with constant stirring. Volatile solvents are condensed in a separate container and reused in the process. Over time, the accumulated water and solvents are, in this case, are drying with suitable adsorbents, such as alumina or granular SaCl2.
Process 1. Isolation of oil from egg egg powder.
The reactor R1 (V = 1m3), solvent-S1 - CH2Cl2 - dichloromethane (500 L) at 20 ° C, with constant stirring over the top loading hatch egg powder 250kg. Reactor content is stirred 1 hour, then use a submersible pump with a filter-tip solution egg oil in the solvent S1 of R1 is fed first into the flow centrifuge (to remove excess egg powder, which fell into the solution), and then - in a vacuum evaporator I1. Here is a selection of egg oil. Egg oil is collected in the bottom of the evaporator and flows into a separate container E4.
The solvent in the vacuum evaporator I1 condensed first in the intermediate tank ES1 and then transferred to its original capacity of E1 for later use in repeating the process.
By remaining in the reactor R1 wet weight of powder added to a fresh portion of the solvent S1 and the process repeated twice more. The remains of the powder in the reactor R1 together with the sediment collected in the centrifuge, promyvayutya again solvent S1 and this stirred suspension is served in a centrifuge. Overlooking the solution into the vacuum evaporator I1 to highlight additional portion of egg oil. Egg oil enters the tank E4 and solvent - in the intermediate tank ES1 and then transferred to its original capacity of E1.
Depending on the fat content in the original egg powder (39-40%) of 250 kg can be almost quantitatively (more than 95%) to provide up to 100 kg of egg oil.
Egg oil is a clear, zheluyu / yellow-red, oily liquid with a characteristic smell of egg.
The main feature of this technology - the use of solvent is not miscible with water, which can not develop disease-causing organisms, and which is not soluble albumin. This process - the subject of the original invention
What remains after the egg oil? Albumin. A solvent after drying returned to the process.
Egg oil is used in shampoos as a nutritional supplement for hair.
Egg oil, like vegetable oil, partially miscible liquids with grease. About the compatibility of the oil with powdered egg in the literature / internet information could be found.
In the oil refining egg is not necessary.
3.Proizvodstvo albumin.
Process 2.
After isolation (extraction) of oil from egg egg powder (Process 1) is pure egg white. It is dried under vacuum of residual solvent CH2Cl2 and, after additional pasteurized, packed in a sealed container.

Dry albumin - a stable product. It is mixed with vigorous stirring with grease, water-based fluids.
Albumin mixed with powders of organic and inorganic origin.
Albumin can refine its manufacturing after placing it in the water.

4. Production of L-?-lecithin.
The feedstock for this stage - egg oil obtained in Process 1.
The reactor R2 (V = 0.6 m3) of E1 pump fed egg oil (100kg). Here is under constant vigorous stirring of the vessel enters solvent E2 S2 - acetone (400l). Fall colored waxy residue. After 1 hour, the upper clear light yellow solution is pumped into a vacuum evaporator I2, which separates the oil from the egg obezletsitinennogo solvent S2. This egg oil (~ 85 kg) from the bottom of the vacuum evaporator I2 poured into a separate container E5 and distilled solvent S2 is condensed and collected in the intermediate tank ES2. The solvent is then pumped to the S2 to its original capacity of E2 and re-used in the process.
To the precipitate (voskoobrazaya red-brown mass) remains in the reactor R2, (the washed twice with 50 liters solvent S2-acetone), E3, from the tank is fed with constant stirring solvent S3 - ethanol (50 liters). The yellow transparent solution L-?-lecithin is pumped into a vacuum evaporator I3, where the selection L-?-lecithin. S3 distilled solvent is condensed and collected in the intermediate tank ES3. The solvent is then pumped to the S3 its original capacity of E3 and reused in this process .L-?-lecithin evaporator I3 after removal of residual solvent is collected in a tank S3 E6 and quickly poured in 40 in a stream of inert gas (nitrogen, argon) hermetically sealed container.
Only store in the fridge!
L-?-lecithin can be turned into a powder of multiple egg extraction residue oil acetone (total consumption to 15 liters of acetone per 1 kg of pure product).
A more efficient method is to use a mixture of two solvents - hexane / acetone from the calculation: in 100 g of lecithin - 50 ml of hexane and 75 ml atsetona.Pri this two phases - the upper, lighter, contains lecithin, and the bottom, heavy-phosphatidyl residues egg oil.
You can spend de-oiling L-?-lecithin by extraction with supercritical CO2.
The literature describes the purification of L-?-lecithin with hexane solution by ultrafiltration through an ultra-filter with a width then, the molecule with mol. weight of approximately 10,000. Passed through the filter solution was almost completely free of phosphatides.
L-?-lecithin is a good emulsifier, has a stabilizing and dispersing properties, and can be mixed with liquid grease.

5. Production of lysozyme.

Raw material for the separation of lysozyme is the original native egg white. 1 liter of liquid egg white contains about 3 grams of lysozyme.

One of the methods described in the literature, is a direct source of lysozyme crystallization liquid egg protein in the presence of 5% NaCl.
Found that in the filter and homogenized egg whites at 4 C, pH = 9.5 (brought with 1N KOH) and the addition of 5% NaCl on standing for 3-4 days, crystals of lysozyme with a yield of 60-80%. Adding a small amount of crystals of lysozyme facilitates the initiation of the process. The resulting crystalline product is dissolved in weak acetic acid (pH 4-6) and all insoluble products are removed by centrifugation. Soluble product was crystallized after addition of 5% NaCl and adjusting the pH to 9.5 - 11.0. You can also quickly complete pre-crystallization added to the acid solution of 5% sodium bicarbonate (pH 8.0-8.5).
Freeze drying process is complete.
Lysozyme solubility in water 10g/ml.
The product should be stored at -20 ° C without loss of activity for at least 4 years.

6. Egg production multivitamins.

In reactor R2 after removing the alcohol solution of lecithin is a viscous red-brown mass - a mixture of multivitamins. It is suspended in 10 liters of hexane (petroleum ether bp 40-60 C) and pumped or drained through the lower hatch of the reactor in a vacuum evaporator. Liberated from the solvent mixture of multivitamins packed in hermetically sealed containers.

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