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Contact Info

Raymond Harris
Program Officer
Office of Biodefense Research Affairs
harrisr2@niaid.nih.gov

Microbiology and Infectious Diseases Resources

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Biopharmaceutical Product Development Services

About

What services does this resource provide?

The Biopharmaceutical Product Development Services program provides services to facilitate preclinical development of materials that are derived from biotechnology processes, such as monoclonal antibodies and derivatives of monoclonal antibodies; recombinant proteins; peptides; nucleic acid based vectors (siRNA, plasmids); and live, modified-live and/or attenuated entities.

Services include

  • Product development planning and evaluation
  • Assay development and product release testing
  • Process development and formulation
  • GMP manufacturing
  • Regulatory CMC documentation support

See examples of services within each of these categories.

A suite of services is provided to support the development of products directed against the full range of pathogens, including bacteria, viruses, parasites, fungi, and other agents such as toxins and prion proteins.

Services will be conducted at the appropriate regulatory compliance level dependent on the stage of product development.

Note: Resources are limited and intended to fill critical gaps and are not to be the sole source of product development. Preliminary data to support program participation are required.

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Last Updated March 05, 2014