Regulatory Beat: FDA Seeks Safer Drugs and Biologics - New safety programs and the Critical Path Initiative aim to establish standards and policies for developing less risky medical products -


Regulatory Beat: FDA Seeks Safer Drugs and Biologics
New safety programs and the Critical Path Initiative aim to establish standards and policies for developing less risky medical products

BioPharm International
Volume 20, Issue 3

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 vectors.

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.


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,

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