ISSN: 2048-9145

Pharmaceutical Bioprocessing

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A biopharmaceutical, additionally referred to as a biologic (al) medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semi synthesized from biological sources. Totally different from whole synthesized prescribed drugs, they embrace vaccines, blood, blood parts, allergenic, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines utilized in cell therapy. Biologics are often composed of sugars, proteins, or nucleic acids or complex mixtures of those substances, or could also be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microorganism. Some regulative agencies use the terms biological healthful product or therapeutic biological product to refer specifically to designed molecule product like protein- and nucleic acid-based medicine, identifying them from product like blood, blood parts, or vaccines, which are sometimes extracted directly from a biological supply. Specialty medicine, a recent classification of prescribed drugs, is high-cost medicines that are typically biologics. The European Medicines Agency uses the term advanced medical care healthful product (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", together with gene therapy medicines, somatic-cell medical care medicines, tissue-engineered medicines, and mixtures therefrom. Inside EMA contexts, the term advanced therapies refers specifically to ATMPs, though that term is quite nonspecific outside those contexts.    

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