Journal Article

Manufacturing Issues with Combining Different Antigens: A Regulatory Perspective

Lydia A. Falk, Juan Arciniega and Loris McVittie

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 33, issue Supplement_4, pages S351-S355
Published in print December 2001 | ISSN: 1058-4838
Published online December 2001 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/322579
Manufacturing Issues with Combining Different Antigens: A Regulatory Perspective

More Like This

Show all results sharing these subjects:

  • Infectious Diseases
  • Immunology
  • Public Health and Epidemiology
  • Microbiology

GO

Show Summary Details

Preview

The regulation of biological products is conducted within the framework Title 21 of the US Code of Federal Regulations (CFR). These regulations describe product and clinical testing requirements for drugs and biological products, as well as the requirements for licensure of such products. The requirements outlined in the CFR also apply to combination vaccines. In addition, the Center for Biologics Evaluation and Research has issued a Guidance to Industry document that discusses the manufacturing, testing, and clinical evaluation of combination vaccines. However, as the complexity of mixing the different antigens increases, the challenges associated with product development (e.g., demonstration of comparability of the components and lot consistency) require early interactions with the US Food and Drug Administration. The many areas of difficulty in the arena of combination vaccine development underscore the need for continued reevaluation of current guidance documents in addressing the increasing complexity of vaccines.

Journal Article.  3548 words. 

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

Full text: subscription required

How to subscribe Recommend to my Librarian

Users without a subscription are not able to see the full content. Please, subscribe or login to access all content.