Línea de producción de vacunas contra la fiebre aftosa

Introduction to suspension culture of Foot-and-mouth disease kit

30 million doses/year

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

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
Pre-domestication cell vector	Post-domestication cell vector

Breakthroughs in large-scale suspension → Large-scale culture bioreactor

→

Project technical route

Chicken embryo vs. cell culture

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 Raㄑ0.20μm. 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.