In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).
Biologics (also called biological medicines or biologicals) are drugs whose active pharmaceutical ingredient is usually obtained or isolated using biotechnological processes. Biologics (translation into German: biologische Arzneimittel, Biologika) include immunological drugs, drugs made from blood, human and animal plasma (except whole blood), biotechnological drugs and gene-therapy drugs. Biologics may contain proteins, antibodies (German: Antikörper), vaccines, hormones and other biologically active substances.
Important characteristics of biologics:
Examples of biologics include, among others, monoclonal antibodies, vaccines (German translation: Impfstoffe), hormones, insulin and growth factors. Biologics represent an important segment of modern medicine, and their development and manufacture require special attention with regard to safety, efficacy and quality.
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