원문정보
초록
영어
Biologics often represent the cutting-edge of biomedical research and may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available. Biologics such as vaccines, plasma-derived products, recombinant products, monoclonal antibodies, cell and gene therapy products are derived from living
organisms, so they are quite different from chemically synthesized drugs. Most biologics are not easily identified or characterized and cannot be completely defined in physical and/or chemical terms alone. Because of characteristics of biologics, there is an increased risk of the introduction of adventitious agents. Biologics tend to be heat sensitive and susceptible to microbial contamination. Therefore, it is necessary to use aseptic principles from initial manufacturing steps. It is also important to make consistent products during manufacturing process and should be guaranteed the quality, safety, and efficacy during the validity period.