Palivizumab
Therapeutic Palivizumab antibody from the original Synagis® commercial drug.
Reference Standard as Aliquots
Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot | Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2019.04 |
Synagis® DE |
4 mg |
Unit: aliquot(s) |
470,00 €
/aliquot
|
|||
2019.06 |
Synagis® DE |
4 mg |
Unit: aliquot(s) |
470,00 €
/aliquot
|
|||
2019.10 |
Synagis® DE |
4 mg |
Unit: aliquot(s) |
470,00 €
/aliquot
|
|||
2020.02 |
Synagis® DE |
4 mg |
Unit: aliquot(s) |
470,00 €
/aliquot
|
|||
2020.08 |
Synagis® DE |
4 mg |
Unit: aliquot(s) |
470,00 €
/aliquot
|
|||
2022.03 |
Synagis® DE |
4 mg |
Unit: aliquot(s) |
470,00 €
/aliquot
|
Biosimilars as Aliquots
Access Batch Specific Analytical Information
Evidentic’s Analytical Data Service includes a comprehensive array of methods to support the drug development process, including structure, aggregation, degree of isomerization, and N-glycans identification of the active pharmaceutical ingredient (API).
Product Information
Here you will find the product information for the reference product.
Synagis®/ Palivizumab Reference Product
| Drug name | Synagis® |
| INN | Palivizumab |
| API type | Palivizumab is a recombinant humanised monoclonal antibody produced by DNA technology in mouse myeloma host cells. |
| Pharmacotherapeutic group | Immune sera immunoglobulins, specific immunoglobulins |
| ATC code | J06BB16 |
| Target of antibody | RSV protein F |
| General function | Palivizumab is a humanised IgG1 monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV). This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences. It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Palivizumab is a humanised IgG1κ monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV). This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences. It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains. Palivizumab serum concentrations of approximately 30 μg/ml have been shown to produce a 99% reduction in pulmonary RSV replication in the cotton rat model. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Palivizumab binds a highly conserved region on the extracellular domain of mature RSV F protein, referred to as antigenic site II or A antigenic site, which encompasses amino acids 262 to 275. The antiviral activity of palivizumab was assessed in a microneutralization assay in which increasing concentrations of antibody were incubated with RSV prior to addition of the human epithelial cells HEp-2. |
| Original license holder | AstraZeneca AB |
| Marketing authorisation numbers | EU/1/99/117/001 |
| Marketing authorisation holder | AstraZeneca AB SE-151 85 Södertälje Sweden |
| Name of the manufacturer of the biological active substance | Boehringer Ingelheim Pharma GmbH & Co. KG D-88397 Biberach an der Riss Germany AstraZeneca Pharmaceuticals Limited Partnership (AZPLP) 660 MedImmune Court / 633 Research Court, Frederick, Maryland, USA |
| Name and address of the manufacturer(s) responsible for batch release | AbbVie S.r.l. 04011 Campoverde di Aprilia (LT) Italy |
| Max shelf life | 48 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Powder: Histidine Glycine Mannitol (E421) |
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