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Filtration in Plasma Fractionation

The methods to extract and purify plasma proteins have existed for over half a century, though new methods are being developed to increase process yields and improve purity. Filters are used in the critical steps of prefiltration and bioburden reduction as well as for sterilizing filtration.

Immunoglobulin, Albumin & Clotting

Immunoglobulin is the most commonly used blood fraction. It is used in immunology and the demand growth in that field is driving the need for higher process yields, while still assuring process safety and reliability.

Albumin is a high volume blood fraction product most often used in anesthesia and surgery.

Clotting factors like Factor VIII are another plasma-derived product range used in the hemostasis area. Demand has grown so quickly that recombinant DNA processes have now been developed to produce some clotting factors. For more information on filters in recombinant DNA based processes, see our Biopharmaceutical Production page.

Development to Production

Critical Process Filtration offers a wide range of products and services for blood fractionation. With configurations from 13mm disc filters to multiple sizes of disposable capsule filters to 5" to 40" cartridge filters, all made with the same attention to quality and cost, process scale up can be easily accomplished using Critical Process Filtration products and support. Whether evaluating the clarification of a precipitate solution, removing unwanted proteins, or validating sterile filtration, Critical Process Filtration will work with you to create the most cost-effective process possible.

This section of our website is focused on blood fractionation. If you are producing small molecule drugs using chemical processes, please visit our Active Pharmaceutical Ingredients page. If you are exploring filter options for cell-culture or modified plant or animal based pharmaceutical production, visit our Biopharmaceutical Production page.

The figures below are simplified schematics of the classic and more modern blood fractionation processes. The applications labeled are discussed briefly below the figure and in more detail on the applications pages.

Filters in Blood Factors Production – Classic Process

Filters in Blood Factor Production – Chromatography Process

Prefiltration & Bioburden Reduction in Blood Fractionation

Removing bacterial contamination that may foul the critical sterilizing filters is the role of the bioburden reduction filters in blood factor production. That means removing at least some of the organisms that might be in the stream, plus smaller particles that may contribute to filter fouling. Sterilizing filters (see below) must be protected from excessive loading by particles or bacteria. The bioburden reduction filters are designed into the system to at least reduce the contaminant load so that the final, sterilizing filters will be able to process an entire batch of product without premature fouling.

The housings marked "2" in the figures are in place to reduce the bacteria and particle load in the blood factor product. Bioburden reduction filters are usually membrane-based filters with pore sizes of 0.45μm to 0.80μm. This filter captures the bulk of the particles and most organisms, though they are not designed to remove all bacteria. One critical consideration in choosing the filters, or any filters for processing blood products, is the ability of the filters to allow the product to pass with a minimum of protein binding. The filters should have little to no impact on the process yield nor should they be easily fouled by the protein content of the stream.

The new High Capacity PES Membrane cartridge filters and capsule filters are examples of filters for bioburden control. Visit our Products page for more information.

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Sterilizing Filtration

The most critical filter in the production of any therapeutic product is the sterilizing filter. Removing any bacteria is critical to patient protection. However, because the blood products are all protein based, the filters must be made of materials that will not absorb proteins or otherwise affect the final purity of the product. Filters used for sterilizing filtration are almost always membrane filters with 0.22µm or 0.10µm pore sizes. The pore size is chosen based on the organisms that have been identified in the customer’s system. For blood products, filter membranes made of materials that are very low in protein binding will allow the product to pass through the filter with minimal loss while capturing bacteria in the product. Final sterilizing filters are integrity tested after the batch is completed to assure that the filter has not been damaged by the process.

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