Plasma Fractionation: The Process of Separating Blood Plasma into Useful Components
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| Plasma Fractionation |
What is Plasma Fractionation?
Plasma fraction is the process of separating the different components of blood
plasma through various physico-chemical processes like molecular size
filtration, precipitation, chromatography and crystallization. Blood plasma,
the liquid part of blood, contains thousands of proteins, antibodies, clotting
factors and other components which help maintain homeostasis in the body. Plasma
Fraction enables isolation of specific plasma proteins on a large scale which
are then used to manufacture life-saving plasma derived medicines, diagnostics
and medical therapies.
Methods used in Plasma Fractionation
Several specialized techniques are employed for separating the individual
components from pooled donor plasma with high precision and purity. These
include:
- Cryoprecipitation: Based on temperature-dependent solubility, this involves
cooling plasma gradually until certain proteins like Plasma
Fractionation precipitate
out. The supernatant plasma is then separated.
- Membrane Filtration: Plasma is passed through semi-permeable membranes of
defined pore size which allows smaller molecules like albumin to pass through
while retaining larger ones like immunoglobulins.
- Ion Exchange Chromatography: Plasma components bind selectively to positively
or negatively charged resins in columns based on their electric charge. Elution
using salt gradients helps separation.
- Hydrophobic Interaction Chromatography: Proteins bind to hydrophobic surfaces
based on non-polar interactions and are separated by altering salt
concentrations.
- Affinity Chromatography: Specific proteins are purified exploiting their
natural binding affinity for certain ligands coated on chromatography columns.
- Solvent/Detergent Treatment: Used to inactivate enveloped viruses while
keeping protein structures intact by adding organic solvents and detergents
followed by their removal.
- Nanofiltration: Further refines product streams by eliminating any remaining
aggregates/contaminants based on molecular weight cut-off.
Major Components Derived and their Uses
Some key plasma derived products obtained through fractionation and their
applications are:
- Albumin: Second most abundant plasma protein used for volume expansion in
surgeries, burns/trauma.
- Immunoglobulins: Antibodies used for treating immune deficiencies,
neurological disorders, infections.
- Clotting Factors: Proteins essential for blood clotting used in treating
hemophilia and bleeding disorders.
- alpha-1 Proteinase Inhibitor: Deficiency causes lung disease; used as
augmentation therapy.
- Antithrombin: Inhibits blood clotting; used for preventing thromboembolic
disorders.
- Protein C: Natural anticoagulant; used for treating severe blood clotting
problems.
Ensuring Quality, Safety and Efficacy
Plasma Fraction is an intricate multi-step process carried out under strict
quality standards. Donor screening and plasmapheresis collect only safe units.
Each production stage is closely monitored and validated to maintain product
identity, purity and strength. Sophisticated testing determines viral safety,
biochemical characteristics and therapeutic potency. Stringent regulatory
approvals globally have made plasma derivatives extremely safe and effective.
Their use has hugely benefited patients worldwide over the last few decades.
Role of Plasma Fraction in Treating Rare Diseases
Plasma Fraction plays a vital role in managing several rare and complex
diseases which otherwise have limited or no treatment options. The purified
plasma proteins derived serve as life-long replacement therapies. For example,
immunoglobulin replacements help patients with primary immunodeficiencies lead
normal lives by preventing infections. Similarly, clotting factor concentrates
help hemophilia patients reduce bleeding risks. Augmentation of alpha-1
proteinase inhibitor changes the course of lung disease in individuals with
genetic deficiency. Plasma Fraction has truly revolutionized care of numerous
previously fatal disorders.
Innovations in collection, fractionation techniques and quality standards have
enabled supply of safe, pathogen-free plasma derivatives on a global scale.
Their clinical use has significantly improved and possibly saved millions of
lives over the decades. With constant refinements, Plasma Fraction will
continue overcoming challenges to deliver next generation therapies addressing
unmet medical needs. It exemplifies the tremendous potential of
biopharmaceutical science for benefiting humanity.
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Author:
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