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Lyophilized Bead Forming System

The emerging technologies for IVD diagnostic sector for PCR test

What is lyophilized bead?

Basic information
Lyophilized bead (lyobeads), also known as pcr bead, it's ready to go pcr beads. Lyobeads are made of reagents or liquid. The reagent or liquid through the professional precision micro-pumps liquid to liquid nitrogen so that they can quickly be frozen into a uniform shape of small solid beads at a very short and very low temperature. Then collected these lyobeads into lyophilizer freeze dryer for frozen storage.

Lyobeads technology can maximize the maintenance of enzyme or protein activities, in addition, lyophilized reagent beads have a loose network structure, they can redissolve rapidly, and lyobeads technology can transform unstable chemical reagents into high-quality, stable, and quantitative lyophilized beads, which is especially convenient for medicine storage and transportation. They are more and more popular new technology nowadays.
The prospect of lyophilized bead
Liquid nitrogen lyophilized bead have developed rapidly in the past two years as one of the hottest emerging technologies in the IVD (in vitro diagnostic) diagnostic sector. Whether in the United States, Germany, The United Kingdom, Russia, or China, many overseas multinational companies and local molecular diagnostic companies are preparing for the development, micro volume, and multitudinous production of new technology for bead pcr.

In IVD exhibitions, from reagent manufacturers to IVD instrument manufacturers, attention to lyobeads technology continues to rise. As overseas multinational companies accelerate the promotion of lyobeads technology and begin to layout mass production. Shortly, lyobeads will become the mainstream of the IVD sector.

In addition, compare to lyobeads, liquid reagents need cold chain transportation and low-temperature storage, which need high transportation and storage costs, and the performance is not stable, the expiration date is very short. Therefore, lyobeads have many advantages. With the reduction of production costs brought by mass production in the future, lyobeads will help the explosive growth of IVD rapid diagnosis.

Applications of lyophilized bead technology

Lyobeads technology means that the liquid reagent is pre-frozen into a solid-state by liquid nitrogen, and then dehydrated by lyophilizer under a vacuum and low-temperature environment. It can be forming high-quality and stable lyophilized beads. Therefore, more and more industries are using lyobeads technology for production and research. And the major applications of lyobeads are mainly in three fields: Biochemical diagnosis, immunologic diagnosis, and molecular diagnosis.

Biochemical diagnosis

In the biochemical diagnosis, lyophilized bead technology is used in a test system which is formed by biochemistry analyzer, biochemical reagents, calibration, it also placed in the hospital clinical laboratory, physical examination center for a routine biochemical test. In addition, lyobeads technology is also widely used in the pet medical market application. As veterinarians need PCR detection, lyobeads emergence greatly solves the problems of liquid PCR reagent degradation failure at normal temperature, short storage efficiency, and high cost of cold chain transportation.

Immunologic diagnosis

Lyobeads can be used for chemiluminescence, enzyme-linked immunosorbent, colloidal gold, biochemical immunoturbidity, latex items, special protein instrument, and so on.
A chemiluminescence analyzer is a product that is made up of reagents, instruments, and analytical methods. Such as protein molecular lyophilization and microbial lyophilization which are mainly used for the diagnosis of tumors, hormones, infectious diseases, and other items.

Molecular diagnosis

This refers to the application of molecular biology techniques to detect structural proteins, enzymes, antigens, antibodies, and various immune-active molecules related to diseases. It is also used in the genes encoding these molecules. At present, lyobeads in molecular diagnosis have been widely used in the detection of viruses, genetic disease, tumors, animal diagnosis, food safety detection, environmental samples detection, and plant breeding.

Advantages of using lyophilized bead

There are so many advantages to using lyophilized bead, in general, there are the following points: 
1. High detection accuracy
2. New technology for rapid diagnosis
3. It can be stored and transported at room temperature after the encapsulation. So that it can reduce the transportation cost.
4. The structure of lyobeads is a loose network, it can redissolve rapidly.
5. Maximizes the activity of enzymes/proteins
6. Wide range of application coverage, from a nucleic acid test, PCR detection, and immunodetection, to environmental detection and so on.

Production process of lyophilized bead

There are five steps involved in the production of lyophilized bead:
The key technical points are as follows:
Micro pump
-- It is a new type of pumping instrument that delivers small quantities of fluid in a precise, minute, uniform, and continuous manner.
-- High precision, consistency, and uniformity for even dispensing of liquid reagents.
-- An expandable number of channels, from small trials to mass production.
-- The droplet size is adjustable.
Liquid nitrogen
-- Using liquid nitrogen can make the reagents that have been dispensed through the micro pump quick-freeze forming.
-- The operation system can allow liquid nitrogen to be added safely and automatically to the reagent
After the step of liquid nitrogen, these shaping reagents will be transferred quickly and safely to the freeze-dryer. The whole process is highly efficient automation.
-- In the freeze-dryer, this equipment will automatically dispense the lyobeads into various forms safely efficiently and quickly, and then packaging, complete product packaging
-- There are mainly three types that can be used to carry lyobeads, these are 8-linked/PCR/ single tubes, Celine bottles and discs.

Performance of lyophilized bead


The technical difficulties of lyophilized bead forming

As lyophilized beads become more and more popular, the demand for liquid nitrogen lyobeads forming system is increasing. Therefore, solving the technical difficulties of liquid nitrogen lyobeads is the primary requirement for making high-quality equipment.
The technical difficulties of liquid nitrogen lyobeads are mainly in three aspects:
1. Microdosing liquid
Common dispensing volumes range from 2ul to 100ul. It is difficult to dispense consistently and consistently in such small amounts if using normal syringe pumps or pipettes. Lyobeads require high precision and dispensing liquid. During operation in the laboratory, as the poor manual consistency and simple equipment, it is difficult to control precision and consistency. Therefore, in the case of microdosing liquid, it will cause the shape of lyobeads to be different in size if a micro pump has poor controllability and accuracy. These will affect subsequent packaging to reagent tray or card, detection process, and detection results.

2. Safely adding liquid nitrogen
Due to the low temperature and continuous volatilization of liquid nitrogen, it is necessary to ensure safety when adding liquid nitrogen, ensure good ventilation in the laboratory, and regularly add and supplement liquid nitrogen

In the case of artificial addition of liquid nitrogen, the operator should make sure the liquid nitrogen container is dry and check whether the container is dented or under other abnormal conditions. At present, the common way to fill liquid nitrogen is the direct funnel pouring method, this method needs operator supervision and requires a regular stop of the machine to add liquid nitrogen. This not only increases the work intensity of the operator, and greatly reduces the production efficiency.

3. The collection of lyobeads
After the lyobeads are produced completely during the day, lyobeads need to be collected quickly and safely from liquid nitrogen containers, because some lyobeads can not stay in low-temperature environment.

The manufacturing equipment of making lyophilized bead

1. Benchtop lyobeads forming system

Micro precision dispensing function: this function adopts a precise micro-ceramic pump with a volume as low as 1mg. The materials are pharmaceutical-grade ceramics and 316L stainless steel, which does not react with liquid. The volume and the speed of liquid dispensed can be adjusted. In addition, all kinds of special needles can be customized, these can solve problems commonly faced by customers, such as lyobeads are easy to drop or burst, the accuracy is not accurate, and poor effect and consistency of beads-forming.

Optional automatic liquid nitrogen feeding device: During the machine working, the high and low-level sensor detects the liquid level change in the liquid nitrogen container automatically, and the signal is automatically transmitted to the liquid level controller, which automatically opens or closes the valve to make sure that the liquid position in the liquid nitrogen container at the working position. This device improves productivity greatly.

Lyobeads collecting device: This device will collect lyobeads quickly if the storage of the lyobeads in the equipment reaches a certain number or special reagents that can not stay for a long time in liquid nitrogen.

The equipment is small so that the space is saved and easy to move.

2. Floor-standing lyobeads forming system

-- High accuracy, the lowest is less than 1%, high repeatability, and reliability.
-- The working speed is very fast, high productivity.
-- Automation. This system can be operated automatically. It has the function of optional digital adjustment of lyobeads capacity.
-- Multiple channels are optional
-- Humanized design, it is convenient to collect lyobeads
-- Reagents can be saved at low temperature and constant temperature and avoiding light.
-- Using stainless steel so that it does not react with reagents.
-- Add reagent stirring function to maintain reagent uniformly.
-- Large volume can volume-produce
-- Speed: maximum 9,000 beads per hour

3. Lyophilized bead packing machine (fully automatic)

Fully automatic packing lyophilized bead, 2,500 beads (8 strips pcr tube) per hour

How to order lyobeads forming system?

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