Lanadelumab is a fully human monoclonal antibody that selectively targets and inhibits plasma kallikrein. It is a targeted biologic therapy used to reduce the frequency of hereditary angioedema (HAE) attacks.
By inhibiting plasma kallikrein activity, lanadelumab reduces the generation of bradykinin, a key mediator responsible for increased vascular permeability and swelling associated with hereditary angioedema.
Lanadelumab is a specialized recombinant monoclonal antibody pharmaceutical ingredient requiring mammalian cell-culture expression, sophisticated purification and extensive biological characterization.
Critical quality attributes include identity, purity, aggregates, molecular integrity, charge variants, glycosylation profile, plasma-kallikrein binding/activity, biological potency, host-cell proteins, residual DNA, endotoxins and sterility.
CAS Number: 1306037-74-2
Molecular Formula: Not applicable as a conventional small molecule
Molecular Weight: Approximately 147 kDa
Drug Class: Plasma Kallikrein Inhibitor
Pharmacological Class: Anti-Plasma Kallikrein Monoclonal Antibody
Therapeutic Class: Biologic / Antiangioedema Agent
Therapeutic Area: Immunology / Rare Diseases
Lanadelumab binds to plasma kallikrein and inhibits its proteolytic activity.
Plasma kallikrein participates in the kallikrein-kinin system and contributes to the production of bradykinin. Excess bradykinin is an important mediator of the swelling associated with HAE.
Lanadelumab therefore:
Lanadelumab is primarily used for routine prevention of hereditary angioedema attacks in appropriate patients.
It is a preventive therapy, rather than a treatment intended to rapidly reverse an acute HAE attack.
Lanadelumab provides targeted inhibition of plasma kallikrein, distinguishing it from therapies that target other components of the HAE pathway.
Its mechanism is particularly relevant to bradykinin-mediated angioedema and the regulation of the kallikrein-kinin system.
Typical manufacturing of lanadelumab may involve:
Lanadelumab quality evaluation may include:
Lanadelumab drug substance and finished product should be stored according to approved product requirements and validated stability data. Appropriate refrigerated storage and protection from freezing, excessive heat and inappropriate light exposure are important for maintaining protein integrity.
Lanadelumab is relevant to research involving:
Lanadelumab is a fully human monoclonal antibody targeting plasma kallikrein, with CAS Number 1306037-74-2 and an approximate molecular weight of 147 kDa. By inhibiting plasma kallikrein and reducing bradykinin generation, it is used for the prevention of hereditary angioedema attacks.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |