Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Manufacturing issues with combining different antigens: a regulatory perspective.

L A Falk1, J Arciniega, L McVittie

  • 1Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|December 26, 2001
PubMed
Summary

Developing combination vaccines requires navigating complex US regulations and guidance documents. Early interaction with the US Food and Drug Administration is crucial for addressing challenges in manufacturing and clinical evaluation.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

In search of acceptable alternatives to the murine histamine sensitisation test (HIST): what is possible and practical?

Pharmeuropa bio & scientific notes·2017
Same author

Alternatives to HIST for acellular pertussis vaccines: progress and challenges in replacement.

Pharmeuropa bio & scientific notes·2016
Same author

Potential application of the consistency approach for vaccine potency testing.

Developments in biologicals·2012
Same author

Health in Byelorussia, a devastated area of the Soviet Union.

American review of Soviet medicine·2010
Same author

Prelicensure evaluation of combination vaccines.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America·2001
Same author

Evaluating the immune response to combination vaccines.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America·2001

Area of Science:

  • Biologics regulation
  • Vaccine development
  • Regulatory affairs

Background:

  • Biological product regulation in the US is governed by Title 21 of the Code of Federal Regulations (CFR).
  • These regulations cover product and clinical testing, as well as licensure requirements for drugs and biological products.
  • Combination vaccines fall under these regulations and have specific guidance from the Center for Biologics Evaluation and Research (CBER).

Purpose of the Study:

  • To outline the regulatory framework for combination vaccines in the US.
  • To highlight the challenges and complexities in developing combination vaccines.
  • To emphasize the need for updated regulatory guidance for increasingly complex vaccines.

Main Methods:

  • Review of Title 21 CFR pertaining to biological products.

Related Experiment Videos

  • Analysis of CBER Guidance to Industry documents for combination vaccines.
  • Identification of challenges in combination vaccine development, such as component comparability and lot consistency.

    • Main Results:

    • Combination vaccines are subject to existing CFR regulations for biological products.
    • Increased complexity in combination vaccines presents significant development challenges.
    • Early and frequent communication with the US Food and Drug Administration is essential.

    Conclusions:

    • Current regulatory frameworks and guidance documents require reevaluation to address the growing complexity of combination vaccines.
    • Addressing challenges in comparability and consistency necessitates proactive engagement with regulatory agencies.
    • Continued efforts are needed to ensure regulatory guidance keeps pace with vaccine innovation.