Biological products are medical products intended for the prevention, treatment or cure of a disease condition in humans or animals. They are also used to prevent or diagnose diseases. Many biological products are made from a variety of natural sources that includes humans, animals, plants and microorganisms. Typical examples of biological products include: vaccines, human insulin, monoclonal antibodies, blood and blood products for transfusion and/or manufacturing into other products, allergenic extracts (which are used for both diagnosis and treatment of allergic conditions), human cells and tissues used for transplantation, gene therapy products, cellular therapy products and test kits to screen potential blood donors for infectious disease agents such as human immunodeficiency virus (HIV) (Figure 1). Biological products or biologics can be composed of sugars, proteins, or nucleic acids, or a combination of these substances; and they may also be living entities, such as cells and tissues. Biological products are produced by biotechnology methods in commercial quantities. Biological products can also be known as biopharmaceuticals. Biological products or biologics differ from the conventional drugs in several ways. In contrast to most drugs that are chemically synthesized and with known structures, most biological products are complex mixtures that are not easily identified or characterized.
Water for injection is a typical example of a sterile biological or biopharmaceutical product used in clinical medicine and other applications. Water for injection (WFI) is water of extra high quality, which is used for production of parenteral such as infusion solution for intravenous therapy (solution for injection) and water-based ophthalmic (eye) products. It is water that is intended for use in the manufacture of medicines for parenteral administration whose solvent is water (WFI in bulk), or water that is used to dissolve or dilute substances or preparations for parenteral administration (heat-sterilized WFI). B. Human insulin. Human insulin is used for the treatment of diabetes mellitus; and the therapy is usually taken as subcutaneous injections by single-use syringes with needles. C. Human plasma. Plasma is a component of human blood cells, and it is used to treat people suffering from medical emergencies. Injuries sustained from accidents, such as burns, trauma and shock, are treated with plasma. Plasma is also used to treat chronic conditions like haemophilia and some autoimmune disorders. Plasma consists of mostly water, electrolytes, hormones, proteins and carbon dioxide; and it provides reserve protein for the body, protects against infections and keeps electrolytes balanced. Plasma carries hormones, proteins and nutrients throughout the body as needed and removes waste products; and it constitutes about 55 % of the total blood cells.
Biological products are usually heat sensitive and thus susceptible to microbial contamination. This is why it is important to always ensure aseptic techniques in the production of these biologics from the initial stage of manufacturing to the last stage of manufacturing. Contamination of biological products during production could result from the personnel involved in the production process; equipment and instrument used for the production; raw materials including water used for the production; and the production environment or facility. The production environment and/or facility involved for the production of biological products should be as sterile as possible (i.e. free from all viable microorganisms capable of causing contamination) in other to ensure that the biological products are fit for animal or human consumption. Materials used in the production of biological products should be sterilized and/or tested in order to ensure that they are free from contaminants before being used or released for public consumption. Samples of the finished biological product should also be tested for the presence of bacterial, fungal, or mycoplasma contaminants.
The primary raw materials for biological production should be collected from sources shown to be free from contamination and they should be handled in such a way as to minimize contamination and the opportunities for any form of microbial contaminant to multiply in them. The materials should be properly sterilized using suitable sterilization techniques that will not affect the quality, texture and the biological activity inherent in the product. Raw materials that are not sterilized and those that are to be processed further after sterilization should be handled aseptically to avoid possible contamination either during storage or handling. The environments in which these materials are processed should always be maintained in a clean state and protected from external sources of microbial contamination. Internal contamination of the clean rooms should also be avoided as much as possible by ensuring aseptic technique at each stage of the production.
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