Conestat alfa is a recombinant analogue of human C1 esterase inhibitor (C1-INH) produced using recombinant DNA technology in the milk of transgenic rabbits. It is a biologic protein used to restore C1-INH activity in patients experiencing acute attacks of hereditary angioedema (HAE) associated with C1 esterase inhibitor deficiency.
Conestat alfa is supplied as a white to off-white lyophilized powder for solution for injection. One vial contains 2,100 units of conestat alfa. After reconstitution with 14 mL of water for injections, the solution contains 150 units/mL of conestat alfa.
Conestat alfa is a recombinant human C1 esterase inhibitor with an amino acid sequence identical to endogenous human C1-INH. It inhibits several proteases involved in the contact and complement systems, including activated C1s, kallikrein, factor XIIa and factor XIa.
C1 esterase inhibitor regulates several proteolytic pathways involved in complement and contact-system activation. Conestat alfa supplements deficient C1-INH activity and helps restore regulation of these pathways during acute hereditary angioedema attacks.
Conestat alfa is manufactured using recombinant DNA technology in transgenic rabbits expressing the human C1-INH gene. The recombinant protein is obtained from rabbit milk and subsequently purified for pharmaceutical use.
The protein is a glycoprotein with an approximate molecular mass of 68 kDa.
Conestat alfa is provided as a sterile, preservative-free white to off-white powder intended for reconstitution before intravenous administration. The reconstituted solution is clear and colorless and should be free from visible particulate matter.
Conestat alfa is indicated for the treatment of acute hereditary angioedema attacks in applicable patient populations with C1 esterase inhibitor deficiency. The approved product is administered by intravenous injection under appropriate medical supervision.
As a recombinant biologic protein, Conestat alfa should be evaluated using validated biologic and protein analytical methods. Relevant quality attributes include identity, protein concentration, biological activity/potency, purity, aggregates, charge variants, host-cell-related impurities, sterility and other applicable critical quality attributes.
Product specifications and release criteria should always be established according to the applicable approved specification and Certificate of Analysis (CoA).
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| pH (1% Solution) | 2.0 – 4.0 |
| Water Content | NMT 0.5% |
| Melting Point | 150°C – 154°C |