Glossary of pharmaceutical and GMP terms with explanations

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

Biologics are an important area in modern medicine, and the development and manufacture of biologics require special attention with regard to safety, efficacy and quality.

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:

  • Complexity: Biological active pharmaceutical ingredients are generally more complex in structure than chemical molecules, as they usually consist of proteins.
  • Manufacture: The manufacture of biologics may require the use of living cells or organisms. This requires specific manufacturing processes and tests.
  • Specificity: Biologics are often specific to certain molecular targets in the body, which can increase their efficacy and reduce side effects.
  • Safety: Biologics are often considered less toxic, but can cause immune reactions.
  • Therapeutic potential: Due to their complex structure and targeted effect, biologics can be effective in the treatment of a variety of diseases such as cancer, autoimmune diseases and more.

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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