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).

Pharmaceutical biology

Pharmaceutical biology deals with drugs of biogenic origin, from which so-called biologics are produced. Biopharmaceuticals are obtained from a variety of organisms or their cells.

Pharmaceutical biology is the field of pharmacy that deals with the research, development, manufacture and application of biologics. In contrast to chemical drugs, which are made from chemical compounds, biopharmaceuticals use living organisms or their components to treat and prevent diseases. The field deals with pharmaceutical substances of biogenic origin, from which so-called biologics (German translation: biologische Arzneimittel) are produced. Biopharmaceuticals are obtained from a variety of organisms or their cells. These organisms include plants, algae, microorganisms (such as bacteria and fungi), but also humans and animals. The spectrum of biogenic pharmaceutical substances ranges from primary and secondary substances to multi-component mixtures and products obtained through recombinant DNA technology. This also includes preparations from living cells (e.g. probiotics or stem cells). Pharmaceutical biology (translation into German: pharmazeutische Biologie) deals with the properties, analytics, biosynthesis, extraction and purity of biogenic drugs.

The most important aspects of biopharmaceuticals include:

Biogenic drugs: Biopharmaceuticals include proteins, antibodies, vaccines (German: Impfstoffe), gene therapies, carrier cells and other biogenic molecules or organisms.
Biotechnology: The development and production of biologics usually requires the use of biotechnology such as recombinant DNA technology, fermentation and cell cultures.
Complexity: Biopharmaceutical products can have a complex structure and consist of living cells, which makes them difficult to manufacture and store.
Specialized equipment: The manufacture and study of biopharmaceuticals often requires specialized equipment and expertise.

Examples of biopharmaceutical products include monoclonal antibodies (German translation: monoklonale Antikörper) to treat cancer, insulin to treat diabetes, vaccines to prevent infectious diseases and many other products that target the body’s biological mechanisms to treat or prevent disease.

Biopharmaceuticals are of great importance in modern medicine, as they offer new and effective treatment options for many diseases. Pharmaceutical biology is constantly evolving and opening up new possibilities for treating diseases and improving health.

The language professionals at GMP-inspection.com are more than happy to translate your specialist pharmaceutical texts and interpret during your GMP inspection, when a foreign regulatory authority inspects your pharmaceutical company. Would you like consultancy in advance of your GMP inspection? You are also welcome to contact us in this case. Our range of services includes representing international pharmaceutical companies and distributing their products in Germany. Contact us today!

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