biothérapeutiques

biothérapeutiques, also called biologic therapeutics, are drugs derived from living organisms or their products. They include substances such as monoclonal antibodies, therapeutic proteins, vaccines, cytokines, and cell‑based therapies. Unlike small‑molecule chemotherapeutics, which are typically synthesized chemically, biothérapeutiques are produced through biotechnological processes such as recombinant DNA technology, cell culture, or fermentation.

The principal applications of biothérapeutiques lie in oncology, immunology, endocrinology, and infectious diseases. For example, monoclonal antibodies can target specific antigens on tumour cells, while recombinant clotting factors treat haemophilia. Gene‑editing approaches, including CRISPR‑based therapies, are emerging as biothérapeutiques that aim to correct pathogenic mutations at the genomic level. Cellular therapies, such as CAR‑T cells, represent a sophisticated class in which patient immune cells are engineered to recognise and destroy malignant cells.

The production of biothérapeutiques involves stringent quality controls to ensure purity, potency, and safety. Regulatory agencies, notably the FDA in the United States and EMA in Europe, require extensive pre‑clinical and clinical data through phased trials before approval. The manufacturing processes are scalable, but they demand specialized facilities and robust guarantees against contamination.

Advantages of biothérapeutiques include high specificity, potential for reduced toxicity, and novel mechanisms of action unavailable to traditional drugs. Their limitations encompass high manufacturing costs, complex storage requirements (e.g., cold chain for proteins), variable pharmacokinetics, and immune‑related adverse effects in some patients. Despite these challenges, ongoing research continues to expand the therapeutic landscape, offering new treatment possibilities for previously untreatable conditions.