Abstract:
The development of safe, effective, and affordable vaccines has become a global effort due to its vast impact on overall world
health conditions. In this paper, a brief overview of vaccine characterization techniques, especially in the area of high-resolution
mass spectrometry, is presented. It is highly conceivable that the proper use of advanced technologies such as high-resolution
mass spectrometry and nuclear magnetic resonance, along with the appropriate chemical and physical property evaluations, will
yield tremendous in-depth scientific understanding for the characterization of vaccines in various stages of vaccine development.
In addition, this approach can potentially be more efficient and effective for supporting vaccine research and development.
cGMP Laboratory of PPD
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New initiatives, strategic planning, and guidance from the World Health Organization (WHO), the US Food and Drug Administration,
the European Union and other regulatory bodies, through collaborations with industry and academia, have resulted in an increasing
level of scrutiny of biologically based pharmaceuticals such as vaccines.1–14 The Draft FDA Guidance for Industry, "Characterization and Qualification of Cell Substrates and Other Biological Starting
Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Disease," indicates a trend
in this direction. Characterizing these drug products is becoming increasingly important in bringing a new vaccine to the
market, since this information helps to define the vaccines' safety and efficacy. Modern mass spectrometric (MS) methods for
characterizing vaccines provide many advantages relative to the more classical characterization techniques that have been
historically employed. Additionally, this technology has applications in all phases of vaccine development.
The development of safe, efficacious, and affordable vaccines is the main focus of multiple government agencies, the WHO,
industry, academia, health care providers, the public, and philanthropic organizations such as the Bill and Melinda Gates
Foundation. Grants funded by the National Institutes of Health (NIH) and the Centers for Disease Control, along with pharmaceutical
industry research, begin the process of developing potential vaccines. The pharmaceutical industry, with oversight from the
FDA, moves these vaccines from early development to clinical trials. The involvement of the public begins with these trials
and continues throughout the useful lifespan of the vaccine. Health care providers and the public provide vital feedback regarding
vaccine effectiveness and complications that are then used to improve the vaccines further.
Background
In general, vaccines are a very heterogeneous group of preventative medicines with an increasingly wide variety of adjuvants
used in their formulation. Some of these adjuvant components can cause unwanted side reactions in the vaccinated individual
that in some cases can result in serious complications. These complications are generally monitored as part of the potency
and toxicity testing of vaccines in animal or other cell-based models, and are the surveillance responsibilities of health
care providers once the vaccines are released. As greater characterization of vaccines becomes more prevalent, it may be possible
to connect structural changes in the vaccine components with lost potency and increased toxicity issues. This, in turn, may
provide a better understanding of how certain vaccines function and interact with the immune system. Information gained in
this area will undoubtedly improve the effectiveness and safety of future vaccines above today's already high standards.
Vaccines can be broken down into three major categories: live vaccines, killed or attenuated vaccines, and component vaccines.
The third type, the component vaccines, are generally the most easily characterized of the three. They usually consist of
a relatively small number of immunogenic molecules and an adjuvant system, which is often well defined. The other two vaccine
types include complex biological components such as attenuated or killed viruses and intact bacteria or multiple bacterial
components. The characterization of these vaccines typically focuses on the adjuvants used to improve effectiveness. Advances
in proteomics make the characterization of even these difficult vaccines more manageable.
