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Mannan-binding lectin (MBL) production from human plasma
1Department of Research and Development, Division of Plasma Products, Statens Serum Institut, Artillerivej 5, DK-2300 Copenhagen, Denmark. inl@ssi.dk
Abstract:
Individuals with low levels of mannan-binding lectin (MBL) appear to be susceptible to infectious diseases. This suggests that substitution therapy with MBL might be a beneficial treatment of patients with MBL deficiency. A production process for an MBL product has been developed from a fraction II+III precipitate obtained by ethanol fractionation of plasma. The MBL process includes three chromatographic steps, where the first and key step is affinity chromatography on a cross-linked agarose matrix selecting for oligomeric, carbohydrate-binding MBL. The yield from the production process is about 25% of the plasma MBL content, and the purity is about 65%. The MBL product shows mannan-binding activity and complement-activating ability. A safety study has shown this plasma-derived MBL to be safe and well tolerated in adult MBL-deficient volunteers.
Insights
Mannan-binding lectin (MBL) deficiency increases infection risk. Plasma-derived MBL shows promise as a safe and effective substitution therapy for MBL-deficient individuals, restoring immune function.
Area of Science:
- Immunology
- Biochemistry
- Therapeutic Protein Development
Background:
- Low mannan-binding lectin (MBL) levels are linked to increased susceptibility to infectious diseases.
- Mannan-binding lectin (MBL) substitution therapy is a potential treatment for MBL deficiency.
Purpose of the Study:
- To develop a production process for plasma-derived MBL.
- To evaluate the safety and tolerability of this MBL product in MBL-deficient individuals.
Main Methods:
- Plasma fractionation using ethanol precipitation.
- Affinity chromatography on a cross-linked agarose matrix for MBL isolation.
- Safety and tolerability assessment in adult volunteers.
Main Results:
- A production process yielding approximately 25% of plasma MBL content with 65% purity was established.
- The MBL product demonstrated mannan-binding activity and complement-activating ability.
- Plasma-derived MBL was found to be safe and well-tolerated in MBL-deficient volunteers.
Conclusions:
- A viable method for producing MBL from human plasma has been developed.
- Plasma-derived MBL is a safe and potentially effective therapeutic option for MBL deficiency.
- Further clinical evaluation is warranted to confirm therapeutic efficacy.
