Biological Performance Review



Biological Performance Review

23  ก.พ. 2560

Potency Biological Performance Review


The Biological examination is divided into 3 types.

Vaccine Potency is the antigenicity of a vaccine that can be detected in two ways.

Direct is a challenge test in animals directly challenged by vaccination for animal testing. Compared to standard vaccines. At the time of injection, followed by the microorganisms or toxin of the microorganism. Count the dead animals. Calculate the potency of the test vaccine against the reference vaccine. The vaccine will pass the standard when potency is equal to or greater. Standard Vaccines Or at least the criteria specified in the requirements of the vaccine. DTP, typhoid, cholera and rabies vaccine are available.


Indirect Method There are two methods.

Detection of Antigen Content. Potency testing by detecting most Ag content is based on the live vaccine. For example, BCG counts the number of cultured particles on the culture medium, MMR vaccines detect virus by virus titration. Use cell culture


Antibody Titer in the serum of vaccinated animals. The potency of Ab titer in animal serum. This is often used for vaccines. By vaccination for experimental animals. After about 4 to 6 weeks, the serum is taken to the Ab level. What type of ab titer will be used to determine the type of vaccine? Compared to standardized vaccines, the titration of vaccines is determined by the number of vaccines tested. The current guinea-pig neutralization test is neutralized standard toxin with antibody dilution and then guinea-pig injection. See guinea-pig death in each dilution. The antibody titer is calculated using standard antitoxin.

Antiserum detects indirect potency, such as tetanus antitoxin. Toxin-antitoxin neutralization by mouse neutralization haemagglutination and ELISA for anti-rabies serum by serum-virus neutralization. Neutralization. There are several ways, such as mouse neutralization and RIFFIT.

Blood product indirectly deters activity from the active/active ingredient, such as blood factor, coagulation activity. Normal immunoglobulin has several active ingredients, such as anti-diphtheria, anti-measles, and anti-measles activity. -rubella Detection of immunoglobulin, specific immunoglobulin, as well as antiserum types prepared from animal origins, such as tetanus immunoglobulin and rabies immunoglobulin.