Swapnroop Drugs & Pharmaceuticals offers Brolucizumab for pharmaceutical research, biologic development and ophthalmic formulation applications.
Brolucizumab is a recombinant humanised monoclonal single-chain Fv (scFv) antibody fragment that binds vascular endothelial growth factor A (VEGF-A). By binding VEGF-A, Brolucizumab prevents VEGF-A interaction with VEGFR-1 and VEGFR-2 and inhibits processes associated with pathological ocular angiogenesis and vascular permeability.
Brolucizumab is a small antibody fragment consisting of the variable regions of immunoglobulin light and heavy chains connected by a short linker peptide. FDA characterization reports a theoretical molecular mass of 26,313 daltons. Brolucizumab is produced in Escherichia coli by recombinant DNA technology and does not contain the Fc region of a conventional immunoglobulin.
KEGG reports the molecular formula as C1164H1768N310O372S8 and molecular weight as 26,312.88 Da.
Product Name: Brolucizumab
INN: Brolucizumab
Synonyms: Brolucizumab-dbll; RTH258; ESBA1008
CAS Number: 1531589-13-5
Molecular Formula: C1164H1768N310O372S8
Molecular Weight: 26,312.88 Da
Biological Class: Recombinant humanised monoclonal single-chain Fv antibody fragment
Therapeutic Category: Ophthalmic anti-VEGF biologic
ATC Code: S01LA06
Target: VEGF-A
Expression System: Escherichia coli
Brolucizumab is used in ophthalmic medicine as an anti-VEGF agent. Beovu, the approved brolucizumab product, is indicated in adults for neovascular (wet) age-related macular degeneration and visual impairment associated with diabetic macular oedema.
The approved product is supplied as a sterile, preservative-free aqueous solution for intravitreal injection. The marketed strength is 120 mg/mL, providing a 6 mg dose in 0.05 mL.
The solution is clear to slightly opalescent and colourless to slightly brownish-yellow.
The approved formulation contains brolucizumab, polysorbate 80, sodium citrate, sucrose and Water for Injection. The FDA label specifies approximately pH 7.2.
Appearance: Clear to slightly opalescent, colourless to slightly brownish-yellow aqueous solution
Identification: Protein identity by appropriate analytical methods including peptide mapping / mass spectrometry
Protein Concentration: 120 mg/mL in the approved Beovu formulation
Molecular Weight: Approximately 26.3 kDa
pH: Approximately 7.2
Strength: 6 mg/0.05 mL delivered dose
Purity: Product-specific biologic purity assessment by validated analytical methods
Aggregates: Controlled by validated size-exclusion analytical method
Charge Variants: Controlled by validated chromatographic method
Potency: VEGF-A binding / biological activity assay
Host Cell Protein: Controlled using validated immunoassay
Host Cell DNA: Controlled using validated residual DNA assay
Sterility: Sterile
Endotoxins: Controlled according to applicable parenteral biologic requirements
Particulate Matter: Controlled according to applicable injectable-product requirements
Osmolality: Controlled according to the approved product specification
Approved Beovu presentations include a glass pre-filled syringe and glass vial. The pre-filled syringe contains 19.8 mg brolucizumab in 0.165 mL solution, while the vial contains 27.6 mg in 0.23 mL solution. Each presentation provides a usable 0.05 mL dose containing 6 mg brolucizumab.
Documentation for a biologic Brolucizumab product may include Certificate of Analysis, analytical specifications, biological activity/potency data, purity profile, sterility data, endotoxin results, residual host-cell protein/DNA results and other applicable quality documentation.
The approved finished product should be stored according to its authorised product information and cold-chain requirements. Follow the applicable approved product specification and stability data for storage and handling.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical and biotechnology customers with sourcing and supply requirements for specialised biologic and ophthalmic pharmaceutical products.
Contact Swapnroop Drugs & Pharmaceuticals for Brolucizumab availability, analytical documentation, packaging and commercial supply information.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | `Peptide Mapping / Mass Spectrometry |
| Loss on Drying | 120 mg/mL |