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Daratumumab | CAS No: 945721-28-8 | GMP-certified suppliers
A medication that treats multiple myeloma and light chain amyloidosis through targeted immunotherapy, available for intravenous or subcutaneous administration in monotherapy or combination regimens.
Therapeutic categories
Primary indications
- Daratumumab is indicated as an intravenous injection alone or in combination with other medications for the treatment of multiple myeloma
- It is available as a combination product with [hyaluronidase] for the treatment of adults with multiple myeloma as monotherapy or combination therapy and light chain amyloidosis in combination with other drugs
Product Snapshot
- Daratumumab is formulated as an injectable monoclonal antibody available for intravenous and subcutaneous administration
- It is primarily used for the treatment of multiple myeloma and light chain amyloidosis
- The product is approved for commercial use in the US, Canada, and EU markets
Clinical Overview
Clinically, daratumumab is indicated for intravenous administration either as monotherapy or in combination with other agents for adult patients with multiple myeloma. A formulation combining daratumumab with hyaluronidase is also available to facilitate subcutaneous administration in similar clinical contexts. It is utilized both in frontline and relapsed/refractory multiple myeloma settings and in combination regimens for AL amyloidosis.
The mechanism of action involves high-affinity binding to CD38 on malignant plasma cells, triggering multiple immune-mediated responses. These include direct induction of apoptosis, antibody-dependent cellular phagocytosis primarily mediated by macrophages, antibody-dependent cellular cytotoxicity through natural killer cells, and complement-dependent cytotoxicity. These processes collectively contribute to the targeted elimination of CD38-expressing tumor cells.
Pharmacodynamically, daratumumab exhibits an extended duration of action, with dosing intervals ranging from weekly to monthly. Key safety considerations include risks of infusion-related hypersensitivity reactions, cytopenias such as neutropenia and thrombocytopenia, potential embryo-fetal toxicity, and interference with blood compatibility testing due to its binding to CD38 on red blood cells.
From an absorption, distribution, metabolism, and excretion (ADME) perspective, as a monoclonal antibody, daratumumab is administered parenterally with distribution predominantly within plasma and extracellular fluid. Its catabolism occurs via proteolytic degradation pathways typical to immunoglobulins, without hepatic metabolism or renal excretion involvement.
For API sourcing and quality assurance, consistent immunoreactivity and structural integrity of the monoclonal antibody are critical. Manufacturing processes should ensure high purity, absence of aggregates, and minimal endotoxin levels, complying with regulatory standards for biological APIs used in oncology and immunotherapy.
Identification & chemistry
| Generic name | Daratumumab |
|---|---|
| Molecule type | Biotech |
| CAS | 945721-28-8 |
| UNII | 4Z63YK6E0E |
| DrugBank ID | DB09331 |
Pharmacology
| Summary | Daratumumab is a monoclonal antibody targeting CD38, a glycoprotein highly expressed on multiple myeloma cells and other hematopoietic cells. Binding to CD38 mediates tumor cell death through apoptosis, antibody-dependent cellular phagocytosis, antibody-dependent cellular cytotoxicity, and complement-dependent cytotoxicity. This mechanism exploits immune effector functions to selectively eliminate malignant cells expressing CD38. |
|---|---|
| Mechanism of action | CD38 is a glycoprotein present on the surface of hematopoietic cells and is responsible for a number of cell signalling functions. Daratumumab is an immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that targets CD38. Cancers like multiple myeloma overexpress CD38, allowing daratumumab to have higher affinity for these cells. This binding allows daratumumab to induce apoptosis, antibody dependent cellular phagocytosis, and antibody and complement-dependent cytotoxicity. Antibody dependent cellular phagocytosis is mediated by the FC region of the antibody inducing phagocytes such as macrophages, antibody dependent cellular cytotoxicity is mediated by the FC region of the antibody inducing effector cells such as natural killer cells, and complement dependent cytotoxicity is mediated by the FC region of the antibody binding to and inducing complement protein activity. |
| Pharmacodynamics | Daratumumab is a monoclonal antibody that targets and induces apoptosis in cells that highly express CD38, including multiple myeloma cells. It has a long duration of action as it is given every 1-4 weeks. Patients should be counselled regarding the risk of hypersensitivity, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interferences with cross-matching and red blood cell antibody screening. |
Targets
| Target | Organism | Actions |
|---|---|---|
| ADP-ribosyl cyclase 1 | Humans | antibody |
ADME / PK
| Absorption | Subcutaneous daratumumab reaches a C<sub>max</sub> of 592µg/mL compared to intravenous daratumumab, which reaches a C<sub>max</sub> of 688µg/mL. The AUC of subcutaneous daratumumab is 4017µg/mL\*day compared to intravenous daratumumab, which has an AUC of 4019µg/mL\*day. |
|---|---|
| Half-life | Intravenous daratumumab has a terminal half life of 18 ± 9 days. Subcutaneous daratumumab has a half life of 20 days. |
| Protein binding | Data regarding protein binding of daratumumab in serum is not readily available. |
| Metabolism | Monoclonal antibodies are expected to be metabolized to smaller proteins and amino acids by proteolytic enzymes. |
| Route of elimination | Monoclonal antibodies are metabolized to amino acids used for synthesis of new proteins or are eliminated by the kidneys. |
| Volume of distribution | Daratumumab intravenous monotherapy has a volume of distribution of 4.7 ± 1.3L and the combination therapy has a volume of distribution of 4.4 ± 1.5L. Subcutaneous daratumumab has a volume of distribution of the central compartment of 5.2L and a volume of distribution of the peripheral compartment of 3.8L. |
| Clearance | Intravenous daratumumab has a clearance of 171.4 ± 95.3mL/day. Subcutaneous daratumumab has a clearance of 119mL/day. |
Formulation & handling
- Daratumumab is a biologic monoclonal antibody available as injectable solutions for intravenous and subcutaneous administration.
- Formulations require careful handling to maintain protein stability; avoid freezing and shaking to prevent denaturation.
- No oral formulations are available, reflecting the peptide/protein nature and sensitivity to gastrointestinal degradation.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently off-patent in the US, Canada, and EU, with established generic availability contributing to a mature market landscape across these regions. Ongoing regulatory approvals continue to support sustained product presence in these markets. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Daratumumab is marketed primarily in the US, Canada, and EU, with multiple branded products available under the Darzalex name, indicating a single originator company with a strong global presence. The current patent status suggests established brand exclusivity, though upcoming patent expiries may lead to the introduction of generic competition in these markets. |
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Safety
| Toxicity | Data regarding overdoses of daratumumab are not readily available. Patients should be treated with symptomatic and supportive measures. |
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- Handle daratumumab with precautions to avoid exposure
- Toxicity data on overdose are limited
- Use appropriate protective equipment to prevent accidental injection or contact
Daratumumab is a type of Monoclonal antibodies
Monoclonal antibodies are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the field of biopharmaceuticals. These antibodies are produced by cloning a single type of immune cell to create identical copies, allowing for targeted treatment of various diseases.
Monoclonal antibodies have gained significant attention in recent years due to their potential in treating a wide range of conditions, including cancer, autoimmune disorders, and infectious diseases. Their specificity and ability to bind to specific antigens make them highly effective therapeutic agents.
These pharmaceutical APIs are typically developed using hybridoma technology or recombinant DNA technology. Hybridoma technology involves fusing antibody-producing cells with immortalized cells to create hybrid cells that produce large quantities of monoclonal antibodies. Recombinant DNA technology, on the other hand, utilizes genetically engineered organisms such as bacteria or mammalian cells to produce monoclonal antibodies.
The production of monoclonal antibodies requires stringent quality control measures to ensure purity, potency, and safety. Extensive characterization and validation tests are conducted to assess their binding specificity, stability, and absence of contaminants.
Monoclonal antibodies have revolutionized the pharmaceutical industry, offering personalized treatment options and improving patient outcomes. They provide targeted therapy with fewer side effects compared to traditional treatments. The development and use of monoclonal antibodies continue to expand, with ongoing research aiming to enhance their effectiveness and broaden their applications.
In summary, monoclonal antibodies represent a significant advancement in the field of biopharmaceuticals, offering targeted therapy for a variety of diseases. Their precise mechanism of action and potential for personalized treatment make them a promising class of pharmaceutical APIs.
Daratumumab (Monoclonal antibodies), classified under Immunomodulators
Immunomodulators, a category of pharmaceutical active pharmaceutical ingredients (APIs), are substances that help regulate and modify the immune response of an individual. These compounds play a crucial role in treating various immune-related disorders and diseases. Immunomodulators work by either enhancing or suppressing the immune system, depending on the specific condition being treated.
Immunomodulators are used in the treatment of autoimmune disorders, such as rheumatoid arthritis, multiple sclerosis, and psoriasis. By suppressing the immune system, these APIs help reduce the overactive immune response associated with these conditions, thereby alleviating symptoms and preventing further damage to the body's tissues.
On the other hand, immunomodulators are also employed to boost the immune system in cases of immunodeficiency disorders. These APIs stimulate the immune response, enabling the body to better fight off infections and diseases. Additionally, immunomodulators are utilized in the prevention and treatment of organ transplant rejection, where they help modulate the immune system to accept the transplanted organ.
The development and production of immunomodulators require rigorous testing and quality control to ensure their safety and efficacy. Pharmaceutical companies carefully formulate these APIs into various dosage forms, including tablets, capsules, injections, and topical preparations, to cater to different patient needs.
In summary, immunomodulators form a vital category of pharmaceutical APIs that regulate and modify the immune system. With their ability to modulate immune responses, these compounds contribute significantly to the management and treatment of various immune-related disorders and diseases, improving the quality of life for many patients.
Daratumumab API manufacturers & distributors
Compare qualified Daratumumab API suppliers worldwide. We currently have 2 companies offering Daratumumab API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, MSDS, USDMF, WHO-GMP | 229 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
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