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Biological Materials

Evidence of Research Output Biological material or application identified or developed as a result of the research study.

The definition of biological materials for this purpose is expansive and includes cells and biological entities as well as those substances described as biologics, biological factors, and biological products.

Cells and Biological Entities
Cells are defined by the National Library of Medicine as the fundamental, structural, and functional units or subunits of living organisms. Included in this group are transformed, hybrid, and tumor cell lines, as well as stem cells, among others. The term “biological entity” is a broad term. Biological entities for this purpose include biological materials typically described as an “organism” as well as non-living entities such as viruses. An organism may be defined as an individual that is capable of carrying out all of life’s functions, such as growth, homeostasis, and reproduction. Included in this group are animal disease models.
Biologics
Biologics are biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology according to the Center for Biologics Evaluation and Research (CBER), a Center within the Food and Drug Administration.
Biological Factors
The National Library of Medicine defines biological factors as endogenously-synthesized compounds that may influence biological phenomena or represent quantifiable biomarkers. Biological factors are a variety of extracellular substances that are not otherwise classified under enzymes, hormones, or hormone antagonists. Included in this definition are antigens, biological markers, blood coagulation factor inhibitors, blood coagulation factors, chemotactic factors, inflammation mediators, intercellular signaling peptides and proteins, pheromones, pigments, and biological toxins.
Biological Products
The National Library of Medicine defines biological products as complex pharmaceutical substances, preparations, or agents of organic origin, usually obtained by biological methods or assay. They are used especially in diagnosis and treatment of disease (as vaccines or pollen extracts). Biological products are differentiated from biological factors in that the latter are compounds with biological or physiological activity made by living organisms. Included in this definition are antitoxins, immune sera, menotropins, Picibanil, plant exudates and preparations, and vaccines.

Discovery of biological materials which may have innovative applications in the research or clinical environment is a critical type of research output. These materials are diverse as are their potential applications. Some examples of specific applications of biological materials include:

  • Biological therapy
  • Delivery mechanism for therapeutic biological materials
  • Genetic tests
  • Sequences for biological materials such as nucleic acids and proteins
  • Personalized medicine applications
  • Cell lines

Assessment

Documentation by research study investigators of biological materials and applications identified or developed as a result of the research study is recommended for tracking of research output.

Search Tip Search using the keywords, title or the name of the author/research study.

Center for Biologics Evaluation and Research (CBER)

The Center for Biologics Evaluation and Research (CBER), operated by the FDA, is responsible for ensuring the safety and efficacy of blood and blood products, vaccines, allergenics, and biological therapeutics. CBER’s regulation of biological products has expanded in recent years to include a wide variety of new products such as biotechnology products, somatic cell therapy and gene therapy, and human cells, tissue and cellular and tissue-based products. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology. These products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.

National Center for Biotechnology Information (NCBI)

The National Center for Biotechnology Information (NCBI) is a national resource for molecular biology information and is especially useful for research studies that generate biological materials. NCBI creates public databases, conducts research in computational biology, develops software tools for analyzing genome data, and disseminates biomedical information – all for the better understanding of molecular processes affecting human health and disease. There are cross-searchable databases on a variety of topics such as nucleotide, protein, structure, taxonomy, genome, expression, and chemical databases. A cross-search allows for searching of multiple databases simultaneously and the results in NCBI are displayed to allow for presentation of search results by individual resource.

Nucleic Acids Research (NAR)

Nucleic Acids Research (NAR) is a fully Open Access journal, providing rapid publication of leading edge research into the nucleic acids. Each year the first issue is devoted to biological databases, and a later issue to relevant web-based software resources. Categories included in the biological database issue include: Nucleotide Sequence Databases, RNA sequence databases, Protein sequence databases, Structure Databases, Genomics Databases (non-vertebrate), Metabolic and Signaling Pathways, Human and other Vertebrate Genomes, Human Genes and Diseases, Microarray Data and other Gene Expression Databases, Proteomics Resources, Other Molecular Biology Databases, Organelle databases, Plant databases, and Immunological databases. All links contained in the NAR Webserver issue have been included in a searchable index called the Bioinformatics Links Directory.

RePORT Expenditures and Results (RePORTER)

RePORTER is a new database that replaces the Computer Retrieval of Information on Scientific Projects (CRISP) database. RePORTER retains all of the search capabilities of the CRISP database which provided information on federally funded biomedical research projects conducted at universities, hospitals, and other research institutions supported by the Department of Health and Human Services (DHHS).

RePORTER provides additional query fields, hit lists that can be sorted and downloaded to Excel, NIH funding for each project (expenditures), and the publications and patents that have acknowledged support from each project (results). RePORTER also provides links to PubMed Central, PubMed, and the U.S. Patent & Trademark Office Patent Full Text and Image Database for more information on research results.

 

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Last updated: July 30, 2009