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

Q: How can I download an article?

To download an article from SID, first log in to the site, search for the article title, and click on the 'Download Article' option.

Q: How can I download an ISI article?

To download an ISI article on SID, enter the keyword or article title in the search bar, view the relevant results, click on the desired article, and select the 'Download Article' option.

Q: How can I access the SID database?

To access the SID database, visit SID.ir, create an account, and log in to access scientific resources.

Q: Is downloading articles from SID free?

Some articles on SID are available for free, while others require payment. Details are specified on the article's page.

FARZAD R.; VAEZ J.; SHAHALI M.

مرکز اطلاعات علمی Scientific Information Database (SID) - Trusted Source for Research and Academic Resources

Seminar Paper

Paper Information

Seminar: IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY
Year:2007 | Issue:18

Download Full-Text

View:

204

Download:

Information Seminar Paper

Title

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

Author(s)

FARZAD R. | VAEZ J. | SHAHALI M.

Keywords

Not Registered.

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.

Multimedia

No record.

Cites

No record.

References

No record.

Cite

APA: Copy

FARZAD, R., VAEZ, J., & SHAHALI, M.. (2007). QUALITY CONTROL OF API, BULK & FINAL HEPATITIS B VACCINE PRODUCED IN IPI. IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY. SID. https://sid.ir/paper/905036/en

Vancouver: Copy

FARZAD R., VAEZ J., SHAHALI M.. QUALITY CONTROL OF API, BULK & FINAL HEPATITIS B VACCINE PRODUCED IN IPI. 2007. Available from: https://sid.ir/paper/905036/en

IEEE: Copy

R. FARZAD, J. VAEZ, and M. SHAHALI, “QUALITY CONTROL OF API, BULK & FINAL HEPATITIS B VACCINE PRODUCED IN IPI,” presented at the IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY. 2007, [Online]. Available: https://sid.ir/paper/905036/en

Related Journal Papers

No record.

Related Seminar Papers

No record.

Related Plans

No record.

Recommended Workshops