Disclosure: how "temperamental" vaccine?

April 27, 2016

Source: xinhua

As a special product, the country is in the first place to the security requirement of the vaccine. Often, a vaccine from r&d to listed must be at least eight years or even 20 years long development stage, to undergo a series of strict management, the vaccine to be registered before are required to pass through the strict animal experiments and clinical research, the vaccine in listed before use to implement the system of strict therelease of, before vaccination, immunization, has a complete, scientific, standardized after inoculation.

So, so strictly to produce vaccine is a "strong" or a "temperamental"? If it is powerful, it can be "strong" to what degree? If it is "temperamental" and "temperamental" to what extent?

Beijing tiantan biological products co., LTD., poliomyelitis live attenuated production workshop

Characters in the biotech research institute co., LTD., deputy general manager, deputy director of the national new vaccine engineering research center, yun-tao zhang said in an interview with xinhua recently, vaccine how much ability to adapt to the environment, need through experiment verification, namely the vaccine stability test, vaccine stability study generally includes the actual storage under the condition of real-time stability study (long term stability study), accelerated stability study and experimental study on the force conditions. Long term stability study can be used as a set product storage condition and the main basis of the period of validity. Acceleration and force condition test can be used to understand the product deviation in the short term preservation condition and the stability of the product, in extreme cases for the period of validity and the determination of preservation conditions provide supporting data.

After automatic inspection machine of vaccines, such as have the bottle crack any does not accord with standard of unqualified vaccine will be removed.

Vaccine stability test to post-marketing before throughout the vaccine development

It is understood that the vaccine accelerated stability test and forced condition test, in the short term can be used to understand the product deviates from the preservation condition and the stability of the product, in extreme cases for the period of validity and the determination of preservation conditions provide supporting data.

Accelerated stability study, it is to point to higher than the actual storage temperature under the condition of stability study, usually refers to 37 ℃ or room temperature. Scientists know products through this experiment, in the short term deviation under the condition of the stability of the products, in order to determine product validity and storage condition provides supporting data.

Forced condition test, it is to point to in effect more severe under the condition of the stability of the research, such as high temperature, light, vibration, repeated freezing and thawing, oxidation and so on.

According to Beijing tiantan biological products co., LTD., general manager of Wei Shuyuan is introduced, in order to guarantee the quality of vaccine, the vaccine to carry out the stability test, throughout the entire drug development stage and after the listing of drug and research.

Administration of state food and drug supervision and administration in April 2015, issued a "biological products stability study technical guidelines", to the vaccine stability test requirements and standards made clear rules, including the vaccine. Therefore, each vaccine registered in pre-market research and development stage, will be challenging test according to the guidelines. The test results, as the basis of establishing the validity of the vaccine and storage conditions.

In addition, approved by the registered after listed, most vaccines each batch before leaving the factory, but also according to the pharmacopoeia of the People's Republic of China of 37 ℃ accelerated stability test. The vaccine before the factory listed, placed at 37 ℃ environment a certain period of time (2-4 weeks), if the content of effective components, such as the number of living bacterium, virus drops, or titer) decline in value at an acceptable range, the quality indexes and the vaccine is still in line with the "Chinese pharmacopoeia" and enterprise registration standards, to determine the vaccine is qualified products, and then release. China pharmaceutical and biological products verification courtyard in therelease of the vaccine, and sampling thermal stability of the product.

Inspection qualified vaccine after issued by batch production enterprises call professional cold chain car transportation to the provincial CDC vaccine storage library.

Different time different vaccines to accept the challenge of 37 ℃

According to the characteristics of different vaccines, they accept the challenge of 37 ℃ time is also different. The China pharmacopoeia (2015 edition) of three vaccine 37 ℃ accelerated stability testing time required is as follows:

A 48-hour test are: live attenuated oral polio vaccine;

Test 72 hours are: freeze-dried live attenuated hepatitis a vaccine.

There for seven days and test: live attenuated Japanese encephalitis vaccine, freeze-dried b encephalitis inactivated vaccines (Vero cell), forest encephalitis inactivated vaccines, bivalent kidney syndrome hemorrhagic fever inactivated vaccines, live attenuated measles, mumps, live attenuated vaccines, live attenuated rubella vaccine (human diploid cells), a live attenuated varicella vaccine, joint live attenuated measles, mumps, rubella measles combined attenuated live vaccine, ma gills wind combined live attenuated; Pharmacopoeia of oral rotavirus vaccine not contains also the thermal stability test for 7 days;

Have for 28 days and test: intradermal injection with BCG, freeze-dried people with rabies vaccine (Vero cells). Some vaccines, their effective components not live bacteria and viruses, such as polysaccharide, polysaccharide protein content, etc. They are in "hot" under the condition of relatively stable material, does not need to be heat stability test, such as: haemophilus influenzae type b (Hib) conjugate vaccine (Hib vaccine), A group of group C meningococcal conjugate vaccine, ACYW135 group of meningococcal polysaccharide vaccine, etc. (Liu Ying)