TIG (Tetanus Immune Globulin) is made from screened and tested donated human blood.
Here's a more detailed breakdown:
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Donation and Screening: The process begins with voluntary blood donations from individuals. Donors are carefully screened for risk factors associated with blood-borne viruses such as HIV and hepatitis.
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Testing: Each unit of donated blood undergoes rigorous testing to detect the presence of various infectious agents, including HIV, hepatitis B, and hepatitis C. This ensures that only safe blood is used for TIG production.
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Plasma Separation: The blood is then processed to separate the plasma, which contains the antibodies, including tetanus antibodies.
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Purification and Concentration: The plasma undergoes a series of purification steps designed to isolate and concentrate the tetanus antibodies. These steps may include precipitation, filtration, and chromatography.
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Inactivation/Removal of Viruses: To further enhance safety, the manufacturing process incorporates methods to inactivate or remove any remaining viruses. These methods may include pasteurization, solvent/detergent treatment, or nanofiltration.
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Formulation and Filling: The purified and concentrated tetanus antibodies are formulated into a stable solution, and then aseptically filled into vials or syringes.
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Quality Control: Throughout the entire manufacturing process, rigorous quality control measures are implemented to ensure the safety, purity, and potency of the final TIG product. This includes testing for sterility, pyrogens, and antibody concentration.
In summary, TIG production is a complex and multi-step process designed to harness the protective antibodies from donated human blood while ensuring the highest levels of safety and efficacy.
