Fig. 1. Figure exhibited the process of producing recombinant biopharmaceutical products involves using genetic engineering techniques to create therapeutic proteins. (A) The first step is to select a suitable host organism, often a microorganism like bacteria, yeast, or mammalian cells. The choice of host organism depends on factors such as protein complexity and desired post-translational modifications. (B) The gene encoding the desired therapeutic protein is isolated and cloned into a vector. The vector also contains regulatory elements to control gene expression. (C) In the case of bacteria, the vector with the cloned gene is introduced into the host cells through a process called transformation. (D) Once the gene is inside the host cells, it is transcribed and translated, leading to the production of the therapeutic protein. (E) The cells are then grown in bioreactors (fermentation tanks) under controlled conditions to maximize protein yield. (F) After production, the biopharmaceutical product needs to be separated and purified from the host cell components. This is typically done through a series of chromatography and filtration steps, which isolate the protein of interest. The purified protein undergoes rigorous quality control testing to ensure it meets safety, efficacy, and purity standards. This includes tests for identity, potency, sterility, and absence of contaminants. The purified protein is formulated to the desired concentration and stability. It may also be mixed with excipients to improve shelf-life and administration. Before receiving regulatory approval, the biopharmaceutical product goes through extensive clinical trials to assess its safety and efficacy in humans. Once clinical trials are successful, the product can be submitted for regulatory approval by health authorities. If approved, the biopharmaceutical is produced at a larger scale and distributed to healthcare providers for patient use.