Paper Information

Title: 

QUALITY CONTROL OF API, BULK & FINAL HEPATITIS B VACCINE PRODUCED IN IPI

Type: SPEECH
Author(s): FARZAD R.,VAEZ J.,SHAHALI M.
 
 
 
Name of Seminar: IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY
Type of Seminar:  CONGRESS
Sponsor:  PHYSIOLOGY AND PHARMACOLOGY SOCIETY, MASHHAD UNIVERSITY OF MEDICAL SCIENCE
Date:  2007Volume 18
 
 
Abstract: 

Hepatitis B recombinant Vaccine (HBV) is a preparation of purified hepatitis B surface antigen (HBsAg) that has been produced by recombinant DNA techniques. The preparation shall satisfy all the production and quality control requirements. The requirements that follow apply to the control and testing of hepatitis B vaccine made by recombinant DNA methods, and have been formulated to take account of the scale-up required for commercial production. General requirements, such as tests for potency, purity, toxicity, pyrogenicity, and sterility, will apply as much to hepatitis B vaccines made by recombinant DNA methods.
Sterility test, specific activity, purity content, antigen homogenicity, determination of endotoxin, yeast protein contaminant, mouse IgG contaminant, yeast DNA contaminant, carbohydrate, lipid, thiocianate ion determination tests were applied for active pharmaceutical ingredients (API). Another tests such as determination of HBsAg desorption to Al(OH)3 and preservative content were added them for HBV bulk too. Tests for pyrogenic substances, abnormal toxicity, potency (in-vitro & in-vivo) were taking placed to all of mentioned tests for HBV as a final product. Analysis of the results by the parallel-line method has been found suitable for most of these techniques. Test results for API, Bulk & final Hepatitis B vaccine indicated they were in the accepted limit according to WHO & NRA requirements completely. So our national recombinant biological product is reliable to use as the best product for vaccination against hepatitis B virus safely.

 
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