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Plasma Options & Characteristics
![Plasma Options & Characteristics]()
Base Material
Plasma
The clear, straw-colored liquid portion of blood which remains after the removal of red blood cells, white blood cells, platelets and other cellular components. Plasma is made of water (90%), salts, enzymes, antibodies and other proteins. It is the largest component of human blood (55%) and is collected from donors via several methods - resulting in unique plasma properties.
Source
Native protein content: 5 to 5.3% Source plasma is plasma that is collected from healthy, voluntary donors through a process called plasmapheresis and is used exclusively for further manufacturing into final therapies (fractionation) or other diagnostic uses. Source plasma donors may be compensated for their time and effort.
Fresh Frozen
Native protein content: 5.5 to 6%. Fresh frozen plasma is collected through whole blood donation in which plasma is separated from its cellular components then frozen solid (≤-18C) within 8-hours of collection. It is primarily used for transfusion but may also be used for other diagnostic purposes.
Recovered
Native protein content: 5.5 to 6% with less intact enzymes/ proteins. Recovered plasma is collected through whole blood donation in which plasma is separated from its cellular components for further manufacturing into final therapies (fractionation) or other diagnostic uses. It is the most economic source of plasma and generally accepted for many diagnostic applications.
Off the Clot
Native protein content: approx. 7%. Off-the-clot serum is collected from blood that is allowed to coagulate naturally after collection. It has not been exposed to any anticoagulant that is why the protein remains higher.
Unit Types & Selection
Single Donor
Depending on base material, individual units range up to approx. 860ml each (or 275ml for off the clot) and can be provided on an individual basis as required by customer.
Pooled
Units can be combined into pools with batch sizes up to 2,000 liters. Single use, tank liners are used to ensure product quality.
Gendered
Units may be sorted (and pooled) into female or male, as desired.
Collection & Testing
Units are collected in US at FDA-licensed facilities. Standard FDA required viral and other testing to show negative reaction, however all human products should be treated as potentially infectious and handled in accordance with universal precautions. Human plasma is for in-vitro diagnostic and research purposes only, and not for therapeutic use.
Special
Units may be screened for additional characteristics (eg. lack of Anti-Tg activity) or confirmation genetic-testing on pools based on specific customer demand.
Processing Options
Defibrinated
Defibrination is undertaken to produce a material more like human serum as required by most diagnostic applications. Monobind adds calcium and thrombin to permit the formation of fibrin which it subsequently removes.
Charcoal Stripped
Defibrinated plasma can be charcoal-stripped to remove small molecules and some proteins.
Delipidated
Defibrinated plasma can be delipidated to remove triglycerides and cholesterol to form a more stable matrix. Monobind typically lowers lipids with fumed silica.
Resin Stripped
Defibrinated plasma can be resin-stripped to remove thyroid hormones.
Charcoal Stripped, Delipidated
Defibrinated plasma can be charcoal-stripped and delipidated to remove small molecules, as well as triglycerides and cholesterol.
Delipidated, Resin Stripped
Defibrinated plasma can be delipidated and resin-stripped to remove triglycerides and cholesterol, as well as thyroid hormones.
Double Charcoal Stripped
Defibrinated plasma can be double-charcoal-stripped to remove a higher percentage of molecules.
Double Charcoal Stripped, Delipidated
Defibrinated plasma can be double-charcoal-stripped and delipidated to remove a higher percentage of molecules, as well as triglycerides and cholesterol.
Final Product
Analyte Profile
Customer specifications including the total protein count, specific levels (enzymes, calcium, ALP, etc.), pH, electrolytes and other target ranges are contained on the Certificate of Analysis. Since specific analyte targets may affect the processing technique they should be communicated at the project’s start. Monobind can assist customers with new projects in determining suitable material-types or processes and can also produce several variations (and lots) for qualification studies.
Special Properties
Monobind can accommodate certain plasma-properties such as HCY depleted, Vitamin B low, Anti-Tg/ Anti-TPO, etc. to meet customer requirements. Please discuss your unique needs with Monobind.
Samples and Inventory
For custom jobs secured by purchase order, Monobind produces the entire batch then supplies a pre-shipment sample for customer approval prior to bulk release.
Monobind maintains an inventory of select materials and samples may be available for a fee. Contact Monobind with specific inquires: sales@monobind.com
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