Biologics is a biopharmaceutical, also known as a biologic medical product, is a product manufactured in, extracted from, or semi-synthesized from biological sources. Biologics are products produced from variety of natural sources - living organisms or contain components of living organisms - human, animal, or microorganism.
Biologics can be composed of sugars, proteins, nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Most biologics are complex mixtures that are not easily identified or characterized. Biological are produced by using biotechnology methods and other cutting-edge technologies, tend to be heat sensitive and susceptible to microbial contamination. Therefore, it is necessary to use aseptic principles from initial manufacturing steps, which is also in contrast to most conventional drugs.
Biologics treat a broad range of common as well as rare diseases and include vaccines, cell and gene therapies, tissues for transplants, and more. Biological products include a wide range of products such as vaccines, blood and blood components, allergenic, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Gene-based, cellular biologics, regenerative medicine product, and tissue-engineered products are at the lead of biomedical research. Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available.
Compliance, Regulatory Strategy and FDA Submission