Related efforts seek to ensure safe biotech manufacturing processes. An FDA collaboration with the National Institutes of
Allergy and Infectious Diseases (NIAID) is examining methods for detecting infectious contaminants in cell cultures and whether
such contaminants increase the risk of causing tumors. To improve characterization of complex biological products, FDA is
exploring how to adapt high-tech imaging methods, such as nuclear magnetic resonance spectroscopy, to better characterize
glycoprotein vaccines, and allergen extracts. A collaboration of FDA, NIH, and other partners is evaluating how well new microarray
technologies and other tools can predict the quality of cell substrates used to manufacture vaccines, protein drugs, and gene
Additional projects focus on modernizing vaccine production. The agency is supporting research to shift influenza vaccine
production from egg-based systems to cell culture substrates and to establish libraries of pandemic influenza virus strains
to facilitate testing of new vaccines for potency and efficacy. These initiatives support efforts to produce safe and low-cost
vaccines for developing countries, such as new vaccines for meningitis and tuberculosis. Also, FDA scientists are collaborating
on research to evaluate the efficacy of mumps vaccines and to develop biomarkers to evaluate the stability and safety of future
vaccines for malaria and leishmaniasis.
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FDA is encouraging new standards for novel drug dosage forms to expand options for drug delivery. One project aims to refine
scientific standards for chemical identity, particle size, and distribution characteristics of active pharmaceutical ingredients
in aqueous nasal spray suspensions. If successful, this approach could be applied to dry powder and metered dose inhalers.
Another FDA–industry collaboration is developing methods to assess the adhesive properties and permeation of different transdermal
products. The objective is to compare drug diffusion and skin permeation through different in vitro methods.
The agency is working to characterize liposomal drug products for their encapsulation efficiency, leakage, and particle size.
The project involves testing performance under physiologic stress factors to develop in vitro cell line bioassay methods to assess changes in liposomes under different conditions.
Another high-profile initiative is to establish standards for multicolor flow cytometry measurements in laboratories and
across instrument platforms. Because flow cytometry data is important in developing many products, a collaboration involving
FDA, NIH, CDC, the National Institute of Standards and Technology (NIST), and industry aims to develop, test, and validate
standards that will ensure comparability of such measurements.
Moreover, FDA is working with other agencies to understand how nanotechnology may contribute to the development of new treatments.
A collaboration with NIST and the National Cancer Institute Nanotechnology Characterization Laboratory has been formed to
develop characterization assays and methods for preclinical and early clinical testing of such products. The agency has also
established a Nanotechnology Task Force and Nanotechnology Interest Group of scientists to provide input on product development.
As part of their efforts to prevent the spread of transmissible spongiform encephalopathy, or Mad Cow disease, FDA scientists
are collaborating with colleagues in other government agencies, academia, and industry to develop technologies to identify
prior contamination of biological products. Such tests could be valuable in ensuring the purity of biotech manufacturing processes
as well as screening blood and tissue.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD 20815, 301.656.4634, email@example.com