Pharmaceutical biotechnology has enabled the creation, modification, and manufacture of recombinant biological products for therapeutic use. Cell lines, recombinant DNA, and highly sensitive and specific analytical methods are now routinely used to design, discover, and evaluate highly specific new drugs, imaging agents, and diagnostics.
Currently available biological drugs primarily fall into two categories: nucleic acid or protein/peptide drugs.
- Nucleic acid drugs. Macromolecular nucleic acid drugs include oligonucleotides and other compounds still in clinical trials, such as gene therapy or microRNAs.
- Protein drugs. Protein and peptide drugs include monoclonal antibodies (mAbs) and recombinant proteins. mAbs are also used as imaging and targeting agents.
Biological drugs are manufactured usually using engineered cells or recombinant methods in vitro, although smaller molecules may be chemically synthesized. Such cell- and gene-based methods are distinctly different from chemical synthetic techniques used to manufacture most small molecule drugs; the manufacturing process and materials used for biologic products are intricately linked to the quality and properties of the product, even when identical gene sequences are being expressed.
Several examples of differences in adverse reactions have been reported for the same recombinant proteins (erythropoietin, interferon-1a, and botulism A toxin) made by different manufacturers or using slightly different processes or materials.
Most biologic products should be refrigerated at 2° to 8°C and should not be frozen, shaken, or exposed to light. Products must be used within a specified time after dilution. Specific product information should always be consulted before storage or use.