Introduction to suspension culture of Foot-and-mouth disease kit
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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.
Key technologies needed to be broken through and major problems expected to be solved
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.
Pourquoi nous choisir
Nos équipes professionnelles
Parmi nos équipes et nos partenaires, nous avons des pharmaciens, des chimistes, des médecins, des chefs de projet, des ingénieurs de production pharmaceutique, des responsables assurance qualité, des ingénieurs produits, des ingénieurs électriciens et des ingénieurs mécaniciens.
Produits certifiés
Les bases de production de nos médicaments sont toutes certifiées par l'OMS-GMP ou PIC/S-GMP. Les normes BP ou USP sont appliquées lors de la production. De nombreux médicaments sont approuvés par la TGA (Therapeutic Goods Administration de l’Australie) et la FDA (Food and Drug Administration des Etats-Unis).
Recherche et développement indépendants
Nous avons une équipe de R&D en Chine pour concevoir et développer des produits répondant aux besoins des clients. Tous nos produits sont certifiés par l'ISO, tels que ISO 9001, ISO 14001 et ISO 13485.
Un ensemble de services complet
L'approche multidisciplinaire et hautement collaborative nous permet de fournir une large gamme de produits et de services, de l'approvisionnement des médicaments au service d'installation des équipements médicaux complexes.
Médicament
Des milliards de médicaments que nous distribuons à nos clients sont tous fabriqués, importés ou exportés auprès des laboratoires pharmaceutiques qualifiées. Les bases de production de nos médicaments sont toutes certifiées par l'OMS-GMP ou PIC/S-GMP. Les normes BP ou USP sont appliquées lors de la production. De nombreux médicaments sont approuvés par la TGA (Therapeutic Goods Administration d’Australie) et la FDA (Food and Drug Administration des Etats-Unis).
Équipement médical
En tant que fournisseur des équipements médicaux, en plus de l’importation et la distribution des équipements venant des fabricants qualifiés, nous disposons aussi d'une équipe de R&D en Chine pour concevoir et développer des produits répondant aux besoins des clients. Tous nos produits sont certifiés par l'ISO, tels que ISO 9001, ISO 14001 et ISO 13485.
Production pharmaceutique
Nous produisons également des bioréacteurs, des fermenteurs, des cuves d'émulsification, des cuves de mélange, des cuves d'inactivation etc. Nous pouvons aussi concevoir et installer des lignes de production de vaccins contre la grippe aviaire ou la fièvre aphteuse, et des lignes de production d'API etc. Nous offrons également un ensemble de services pour la culture des vaccins et la production pharmaceutique, y compris la conception et la fabrication des réservoirs, l'installation sur place, la mise en service, la formation des personnels et le service après-vente etc. Ces services assurent l'efficacité et la fiabilité des lignes de production, et garantit ainsi la bonne qualité et l'efficacité des médicaments produits, qui peuvent être mise en bouteille ou mise en stock directement. La société a déjà réalisé de nombreux projets dans le domaine de production de vaccins et d'API en Chine. Nos expériences riches et nos technologies avancés permettent de réaliser une conception optimisée et d'assurer le succès du projet.
Que pouvons-nous faire pour vous
Notre coopération pourra vous apporter, à vous et à votre pays, les avantages suivants:
· Nous pouvons assurer que la qualité, la sécurité et l’efficacité des médicaments fournis répondent aux normes appropriées
· Vous aurez une chaîne d'approvisionnement rentable dans votre pays pour assurer l'approvisionnement des médicaments répondant en temps opportun aux besoins du peuple et avec un prix raisonnable pour les individus et les organisations sociales.
· Les coûts d'approvisionnementdes médicaments pris en charge par le gouvernement seront réduits
· La qualitédes médicaments sera améliorée.
· Vous pourrez développer l'industrie pharmaceutique dans votre pays pour assurer le développement et le progrès continus de l'industrie.
· Vous pourrez combler les lacunes du marché et résoudre de manière rapide et efficace certains problèmes tels que les pénuries de médicaments
· Nous pouvons fournir des solutions techniques et les services d'installation des lignes de production de vaccins.
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Fujian Qiquan Import and Export Trading Co., Ltd.
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