Introduction to suspension culture of Foot-and-mouth disease kit
Summary:Our products also include: bioreactor, fermentor, emulsion tank, mixing tank and inactivation tank. We provide a complete set of services such as the design and construction of avian influenza vaccine production line, foot-and-mouth disease vaccine production line and API production line, as well as vaccine cultivation and drug production, including tank design, tank production, on-site installation
Introduction to suspension culture of Foot-and-mouth disease kit
30 million doses/year
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Plans for a foot-and-mouth disease vaccine factory
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Approximately 12,500 m2 of space required
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Annual production: 30 million doses/year = 60 million ml = 60 tons of vaccine.
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9 months of production per year
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6.6 tons per month to 4 days a batch, 7 batches per month, 1 ton per batch of suspension fermenters to catch the poison, inactivated
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Purified and concentrated into 1000L refrigerated, 1:1 emulsified
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Emulsification ratio 1:1 out of 6.6 tons of vaccine per month
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60 tons of vaccine for 9 months
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Concentrate 1-2 times
FUL equipment for 30 million doses/year
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We provide a full set of suspension equipment / 2 sets of 7L / 2 sets of 120L / 2 sets of 650L / 3 sets of 1000L.
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Two sets of 500L dispensing tank, one set of 300L lye tank, one set of 1000L concentration tank, one set of concentration equipment, one set of 1000L protein purification tank and one set of centrifuge.
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Three sets of inactivation tanks 1000L, one set of constant temperature water tank 1000L.
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Emulsification system: oil-phase tank 1000L, water-phase tank 1000L, emulsifying tank 2000L, high speed emulsifying head, emulsifying premixing tank 2000L.
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All the above equipments are equipped with filters, valves, pipes, control systems and meters.
Foot and mouth disease production line
Technical support from foreign counterparts
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Technology absorption/cooperation
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Broch-BIO (Sartorius) Collaboration: a full-suspension cell line from BHP Anthem
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BiOENGiNEERiNG Collaboration: Tianbang Microcarrier Cell Lines
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NBS (Eppendorf) Collaboration: Qilu kinetic protection microcarrier cell line
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Cooperation with PIERRE-GUERIN SAS (PG, France) on cell production systems (laboratory to large scale production), and conducted several technical exchanges and on-site instruction at theFUL site involving:
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Bioreactor structure, material selection, stirring method (computer-aided simulation design method), local processing accuracy, opening position Considerations, piping design, 3D blind ends, interface methods, connection methods and key controls (hardware selection, software architecture, auxiliary functions) (etc.), system integration extensions, etc. and applied to actual projects.
Chengdu Zhongmu porcine circovirus (PCV) suspension project
Shandong Xinde Cell Suspension Culture
Qianyuanhao Zhengzhou Avian Influenza Project
Chengdu Zhongmu porcine circovirus (PCV) suspension project
Shandong Xinde Cell Suspension Culture
System Integration
Equipment exported to Vietnam and other countries
Process advantages and disadvantages comparison
At present, all domestic and foreign production enterprises use chicken embryo production process, and there are problems such as unstable source of chicken embryo, easy to carry pathogens, high risk of spreading poison and high labor cost.
Serum-free culture → Implementation of MDCK suspension culture
Implementation of MDCK suspensioReducing and controlling the concentration of walling factors in the culture medium and other factors, which can reduce the concentration of serum in the culture medium until it reaches zero, and can scale up to more than 50 generations. Modified MDCK cells can propagate on serum-free medium.
| Cell density 1 million/ml | Cell density over 8 million/ml |
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Pre-domestication cell vector |
Post-domestication cell vector |
Breakthroughs in large-scale suspension → Large-scale culture bioreactor
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→ |  |
Project technical route
Chicken embryo vs. cell culture
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Chicken embryo vaccine production
-Isolation of chicken embryos and culture of candidate vaccine strains
-Years of development and technological maturity
Disadvantages：
- Multiple passages of high-yielding strains produce irreversible mutations, and the supply of embryos needs to be planned and cannot cope with a large pandemic influenza
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Cell culture vaccine production
Easily standardized and accepted in the WHO context.
Large range, fast
Cells and vaccine stromal cells must match
Scalable, rapid and independent of the supply of biological materials.
Clean and easy quality control
Low production risk, high purity
Good stability.
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Disadvantages of cell culture vaccine production: Not yet nationally accepted, not enough research in this area.
1. Underestimating the effectiveness of cellular vaccines
2. Need identification of suitable cell lines, removal of exogenous factors and safety studies currently lack standardization of cell lines.
3. Need further research and development, and need control of exogenous viruses
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Working volume ：5 L to 6000 L, vertical
Main material ：
Imported Ottokumpu 316L plate, designed and manufactured according to the requirements of national standard pressure vessel.
Using Hokkaido Cap, cold forming imported stainless steel, easy to polish, liquid in the surface of the head does not adhere.
Jacket material: 304 steel, honeycomb jacket, heat can transfer evenly, no short circuit.
Compared with traditional coil jacket, heat transfer efficiency is more than 50% higher. The welding area is small, which ensures the maximum degree of inner cylinder base material.
The working pressure in the tank is 0-0.30Mpa. The working pressure of jacket 0-0.35Mpa.
Working temperature inside the tank is 145℃, 150℃ in the jacket.
Internal polishing to Ra≦0.20μm. Electro-polishing can be done according to customer demand.
Washing plate material: PTFE. Can rotate 360 ° automatically in place and clean thoroughly under the pressure of 0.1Kg , specifications DN25 , which complies with FDA hygiene requirements.
Integrated Sight glass, complies with GMP requirements. Working voltage: 24V, power: 25W, LED cold light source sight lamp, high temperature resistant borosilicate glass, sanitary quick-open connection.
Pneumatic bottom valve, 316Lsteel, double diaphragm, with bypass valve, independent sterilization, no dead spot, novel structure.
Independent sterilizable sampling valve DN10, 316L steel, independently online cleaning, sterilization, complies with FDA requirements.
Foam electrode, automatic detection , each set is equipped with a peristaltic pump to automatically add defoamer. Automatic defoaming control sensitivity 100～100000Ω, automatic control, abnormal recording and alarm. Including foam sensor, peristaltic pump, refill bottle, alarm, and foam control
Bottom mounted magnetic stirrer.
0-200rpm, low shear, good mixing effect, allow free floating culture and microculture cell culture.
Inverter, PID automatic control, 0-200rpm, speed display, control accuracy: ±1r/min.
Temperature sensor, automatic detection; replaceable processing probe, protective sleeve made of 316L steel, can be displayed on site or transmitted to the PLC with automatic temperature control system (each tank can operate independently).
PID control: associated with steam and refrigerant. Automatic temperature control, display range 0 ~ 150℃, resolution 0.1℃, control accuracy ±0.3℃. Pt100 temperature sensor: automatic detection; output: 4-20mA, PID control, including temperature sensor, pneumatic Angle valve, circulation pump, safety valve, etc.
METTLER TOLEDO PH sensor, pH controller, pH gel electrode (display range 2 ~ 12, resolution 0.01pH, control accuracy ±0.02pH) Shielded wires. 2 peristaltic pumps automatically control the flow of acid-base adding with range 2～12, can be set arbitrarily, control accuracy ±0.05. Resolution 0.01. Including abnormal alarm, PH sensor, peristaltic pump, general alarm, etc.
DO sensor(dissolved oxygen), PID automatic control, air flow is controlled by mass flow meter; it can also be associated with the stirring speed control, i.e. adjusting the DO by changing the stirring speed. Control range: 0-100%, display range: 0-300%, control accuracy: ±5%; resolution: 1%; with real-time curve and historical curve.
Ventilation: Unique bubble-free ventilation device. Completely solve the damage of bubbles to cells under various culture conditions, increase oxygen transfer rate, allow high-density culture;.
Glass plate liquid level meter can be configured according to customer needs, flange interface, complies with GMP requirements.
Differential Pressure Level Sensor Adopts German electronic differential pressure level sensor, complies with GMP requirements; measurement accuracy is better than weighing mode, can display weight and liquid level height on site, output: 4-20mA.
Pressure sensor: 0-0.6Mpa, sanitary type. 4-20mA signal output.
Diaphragm pressure gauge: 0-0.6Mpa, sanitary type.Stainless steel pressure gauge is easy to install , remove and clean, complies with the requirements of GMP specifications.
Medicine
We receive, export and import multibillion-level worth of drugs from qualified pharmaceutical factories, and then distribute them to our customers. The production bases supplying our products have passed the certification of WHO-GMP or PIC/S-GMP and engage in production in accordance with BP or USP standards. Many of our products have been approved by the Australia-based TGA (Therapeutic Goods Administration) and the US-based FDA (Food and Drug Administration).
Medical equipment
As a medical equipment supplier, we not only import and distribute medical equipment from qualified manufacturers, but also have a R&D team in China that designs and develops products to meet customers' needs. Our products have passed international certifications such as ISO 9001, ISO 14001 and ISO 13485.
Pharmaceutical
Our products also include: bioreactor, fermentor, emulsion tank, mixing tank and inactivation tank. We provide a complete set of services such as the design and construction of avian influenza vaccine production line, foot-and-mouth disease vaccine production line and API production line, as well as vaccine cultivation and drug production, including tank design, tank production, on-site installation, on-site operation and commissioning, personnel training, after-sales service, etc., so as to ensure that the production lines are convenient, efficient, safe and reliable and that our finished products are of high quality and good efficacy and can be directlycanned as commodities or stored. Our company has completed many similar vaccine and API production projects in China and has along the way accumulated rich experience and technology to help with process design and ensure the success of the project.
What can We Do for You?
We believe that our cooperation will benefit you and your country as follows:
Ensure that the drugs supplied meet the relevant standards interms of quality, safety and efficacy;
· Establish a cost-effective supply chain in your country to ensure that people can get the drugs that they need in time, and provide a price range affordable to individuals or social organizations;
· Help governments to reduce the cost for drug procurement;
· Improve the quality of drug use;
· Develop pharmaceutical industry in your country to ensure the sustainable development and progress of the industry;
· Fill the market gap. Drug shortages and other issues can be resolved in a timely and effective manner.
· Provide technical plans of vaccine production line as well as construction services.
Key words：Pharmaceutical Medicine Medical equipment
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Fujian Qiquan Import & Export Trading Co., Ltd.
Address: Fu’er Biological Industrial Ecological Park, No.6 Jinpu Road, Cangshan Science and Technology Park, Cangshan District, Fuzhou, Fujian
Post Code：350000
Mobile Phone：+86 17853667672
E-mail：fjqiquan@163.com
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