Therapeutic Mosunetuzumab antibody from the original Lunsumio® commercial drug.
Product batch
| Expiry date
| Brand & Origin
| Price
| 1. Select quantity range | 2. Your quantity | |
|---|---|---|---|---|---|---|
Date to be defined |
Lunsumio® DE |
316,00 €
/mg
|
Select quantity:
|
mg |
Evidentic’s analytical service includes a comprehensive array of methods to support the drug development process, including, for example, structure, aggregation, degree of isomerization and N-glycans identification of the active pharmaceutical ingredient (API).
Here you will find the product information for the reference product.
| Drug name | Lunsumio® |
| INN | Mosunetuzumab |
| API type | Mosunetuzumab is a full-length, humanized anti-CD20/CD3 immunoglobulin (Ig)G1 isotype that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Antineoplastic agents; other antineoplastic agents; monoclonal antibodies |
| ATC code | L01FX25 |
| Target of antibody | CD20, CD3 |
| General function | |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Mosunetuzumab is an anti-CD20/CD3 T-cell engaging bispecific antibody targeting CD20-expressing B-cells. It is a conditional agonist; targeted B-cell killing is observed only upon simultaneous binding to CD20 on B-cells and CD3 on T-cells. Engagement of both arms of mosunetuzumab results in the formation of an immunologic synapse between a target B cell and a cytotoxic T cell leading to T-cell activation. Subsequent directed release of perforin and granzymes from T-cell activation through the immunologic synapsis induce B-cell lysis leading to cell death. Lunsumio caused B-cell depletion (defined as CD19 B-cell counts < 0.07 x 109 /L) and hypogammaglobulinemia (defined as IgG levels < 500 mg/dL). |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | |
| Original license holder | |
| Marketing authorisation numbers | EU/1/22/1649/001 EU/1/22/1649/002 |
| Marketing authorisation holder | Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany |
| Name of the manufacturer of the biological active substance | Genentech, Inc. 1 DNA Way South San Francisco, CA 94080 USA F.Hoffmann-La Roche AG Grenzacherstrasse 124 4058 Basel Switzerland |
| Name and address of the manufacturer(s) responsible for batch release | Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen GERMANY |
| Max shelf life | 3 years Diluted solution Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C - 8 °C and 24 hours at 9 °C - 30 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions. |
| Storage conditions | 2°C – 8°C |
| List of excipients | L-histidine L-methionine Acetic acid (pH adjustment) Sucrose Polysorbate 20 (E 432) Water for injections |
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