Plasma is manufactured through a process called fractionation, which separates proteins to create various plasma protein therapies. This intricate process relies on established purification methods.
The Fractionation Process
Fractionation involves separating different components of plasma using techniques like:
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Precipitation: This involves using chemicals or adjusting temperature to selectively cause certain proteins to become insoluble and form a precipitate, allowing them to be separated.
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Centrifugation: This technique uses centrifugal force to separate substances of different densities. Heavier components, like precipitated proteins, settle at the bottom of the centrifuge tube, while lighter components remain suspended.
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Separation: Various separation techniques, such as chromatography, are employed to isolate specific proteins based on their size, charge, or binding affinity.
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Filtration: This process uses filters with varying pore sizes to separate proteins based on their molecular weight. Ultrafiltration is a common method used to concentrate and purify plasma proteins.
Steps Involved in Plasma Manufacturing (Fractionation)
The typical steps include:
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Collection: Plasma is collected from healthy donors through a process called plasmapheresis.
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Testing and Screening: Collected plasma undergoes rigorous testing to ensure it is free from infectious agents like viruses and bacteria.
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Fractionation: As detailed above, this is the core process of separating the desired proteins.
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Purification: Further purification steps ensure the final product is highly pure and safe.
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Formulation: The purified proteins are formulated into specific therapeutic products.
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Filling and Packaging: The formulated products are filled into vials or other containers and packaged for distribution.
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Quality Control: Each batch undergoes strict quality control testing to ensure it meets all safety and efficacy standards.
Therefore, plasma manufacturing is a multi-step process that requires advanced techniques to separate and purify plasma proteins for therapeutic use.
