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Trastuzumab | CAS No: 180288-69-1 | GMP-certified suppliers
A medication that treats HER2‑positive breast and certain metastatic gastric cancers, supporting reliable oncology regimens for diverse clinical settings.
Therapeutic categories
Primary indications
- For the adjuvant treatment of HER2-overexpressing breast cancer, trastuzumab is indicated in several clinical settings: as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
- As part of a treatment regimen with docetaxel and carboplatin
- Or as monotherapy following multi-modality anthracycline-based therapy
Product Snapshot
- Trastuzumab is an injectable monoclonal antibody available as IV or subcutaneous formulations, typically supplied as lyophilized powder or solution for reconstitution
- Its primary uses are for HER2‑positive breast cancer across early, adjuvant, and metastatic settings, as well as HER2‑overexpressing metastatic gastric and gastroesophageal junction adenocarcinoma
- The product is approved in major markets including the US, Canada, and the EU
Clinical Overview
Pharmacodynamically, trastuzumab inhibits proliferation of HER2‑overexpressing tumor cells and mediates antibody‑dependent cellular cytotoxicity. It also reduces HER2 signaling through receptor downmodulation and blockade of extracellular domain cleavage.
The mechanism of action involves binding to the extracellular region of HER2, preventing receptor activation and limiting downstream pathways including MAPK and PI3K/Akt. This promotes cell cycle arrest and reduces tumor cell survival. Natural killer cell recruitment drives additional cytotoxic effects. Intrinsic or acquired resistance has been associated with PI3K pathway activation, PTEN deficiency, and compensatory growth factor receptor signaling.
Trastuzumab exhibits target-mediated disposition, long systemic half‑life typical of IgG1 antibodies, and is cleared primarily through catabolism. No clinically meaningful QTc effects have been observed.
Safety considerations include infusion reactions, cardiotoxicity risk particularly with anthracyclines, and rare severe hypersensitivity. Monitoring of left ventricular function is standard. Toxicities in gastric cancer regimens reflect combined cytotoxic exposures.
Notable brands and biosimilars include Herceptin, Ogivri, Herzuma, Kanjinti, Ontruzant, and Herwenda, with global approvals across major regulatory agencies.
For API sourcing, procurement should confirm CHO‑based biologic manufacturing controls, validated cell bank lineage, robust viral safety steps, and analytical comparability aligned with biosimilar and biologics quality guidelines.
Identification & chemistry
| Generic name | Trastuzumab |
|---|---|
| Molecule type | Biotech |
| CAS | 180288-69-1 |
| UNII | P188ANX8CK |
| DrugBank ID | DB00072 |
Pharmacology
| Summary | Trastuzumab is a humanized monoclonal antibody that targets the extracellular domain of the HER2 receptor, a tyrosine kinase frequently overexpressed in certain tumors. By blocking HER2 signaling and promoting receptor downregulation, it reduces activity of downstream pathways that drive cell growth and survival. The antibody also engages immune effector mechanisms, including antibody‑dependent cell‑mediated cytotoxicity, to enhance elimination of HER2‑expressing tumor cells. |
|---|---|
| Mechanism of action | Trastuzumab is a recombinant humanized IgG1 monoclonal antibody against the HER-2 receptor, a member of the epidermal growth factor receptors which is a photo-oncogene. Over-expressed in breast tumour cells, HER-2 overamplifies the signal provided by other receptors of the HER family by forming heterodimers . The HER-2 receptor is a transmembrane tyrosine kinase receptor that consists of an extracellular ligand-binding domain, a transmembrane region, and an intracellular or cytoplasmic tyrosine kinase domain. It is activated by the formation of homodimers or heterodimers with other EGFR proteins, leading to dimerization and autophosphorylation and/or transphosphorylation of specific tyrosine residues in EGFR intracellular domains . Further downstream molecular signaling cascades are activated, such as the Ras/Raf/mitogen-activated protein kinase (MAPK), the phosphoinositide 3-kinase/Akt, and the phospholipase Cγ (PLCγ)/protein kinase C (PKC) pathways that promote cell growth and survival and cell cycle progression . Due to upregulation of HER-2 in tumour cells, hyperactivation of these signaling pathways and abnormal cell proliferation is observed. Trastuzumab binds to the extracellular ligand-binding domain and blocks the cleavage of the extracellular domain of HER-2 to induce its antibody-induced receptor downmodulation , and subsequently inhibits HER-2-mediated intracellular signaling cascades. Inhibition of MAPK and PI3K/Akt pathways lead to an increase in cell cycle arrest, and the suppression of cell growth and proliferation . Trastuzumab also mediates the activation of antibody-dependent cell-mediated cytotoxicity (ADCC) by attracting the immune cells, such as natural killer (NK) cells, to tumor sites that overexpress HER-2 . While the drug alone has a minimal potential to induce complement-dependent cytotoxicity (CDC),one study demonstrated increased therapeutic effectiveness and a synergistic effect on uterine serous carcinoma cells _in vitro_ when used in combination with [pertuzumab], which also has minor effects on CDC alone. This study showed that only the combination of both cell-bound antibodies would be sufficient to bind and activate the complement component 1q (C1q) required to initiate the complement cascade reaction. Intrinsic trastuzumab resistance has been noted for some patients with HER-2 positive breast cancer. Mechanisms involving trastuzumab resistance include deficiency of phosphatase and tensin homologue and activation of phosphoinositide 3-kinase, and the overexpression of other surface receptors, such as insulin-like growth factor . |
| Pharmacodynamics | Trastuzumab exerts an antitumour activity and is used in the treatment of HER2-positive breast cancer. HER2 protein overexpression is observed in 20%-30% of primary breast cancers thus HER2 presents as a useful therapeutic target for the treatment of breast cancers. Trastuzumab has been shown, in both _in vitro_ assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2. It works as a mediator of antibody-dependent cellular cytotoxicity, where it binds as an antibody to cells over-expressing HER2, leading to preferential cell death. Trastuzumab was also shown to inhibit angiogenesis of tumor cells _in vivo_ . Higher doses and longer dosing intervals show no significant benefit over standard dose schedules . In patients with HER2 positive solid tumours, trastuzumab did not exert any clinically significant QTc interval duration. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Receptor tyrosine-protein kinase erbB-2 | Humans | binder, antibody |
ADME / PK
| Absorption | Peak and trough plasma concentrations at steady state (between weeks 16 and 32) were approximately 123 and 79 mcg/mL, respectively. At the highest weekly dose studied (500 mg), mean peak serum concentration was 377 mcg/mL. |
|---|---|
| Half-life | The terminal half-life is approximately 28 days,but may decrease with lower doses - at the 10mg and 500mg doses, half-lives averaged approximately 1.7 and 12 days, respectively. |
| Metabolism | After it binds to HER2, trastuzumab is metabolized intracellularly into smaller peptides and amino acids. |
| Route of elimination | Following metabolism, the complex elimination of trastuzumab in humans is mediated by epithelial cells in a dose-dependent (nonlinear) fashion.The renal excretion of trastuzumab is very low. |
| Clearance | The predicted steady-state clearance of trastuzumab is 0.173 - 0.337 L/day, dependent primarily on the dosing regimen.The clearance rate for subcutaneously administered trastuzumab, formulated with hyaluronidase for improved subcutaneous absorption, is 0.11 L/day. |
Formulation & handling
- Trastuzumab is a monoclonal antibody requiring parenteral administration, supplied mainly as lyophilized powder or ready‑to‑use solutions for IV or SC delivery.
- Reconstitution and dilution demand gentle handling to avoid protein denaturation, with attention to buffering, avoidance of agitation, and protection from excessive heat or light.
- Cold‑chain storage is required for both powder and solution presentations, with limited stability after reconstitution or dilution.
Regulatory status
| Lifecycle | The API’s Canadian patent expired in 2012, indicating long-standing loss of exclusivity and a mature competitive environment. With availability across the US, Canada, and the EU, the product is well established and likely subject to broad generic presence. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Trastuzumab is supplied primarily by the originator group associated with Roche/Genentech, with additional packaging entities contributing to distribution. Branded products are established across the US, Canada, and EU. The listed Canadian patent expiry in 2012 indicates that biosimilar competition is already present or well‑established in these markets. |
|---|
Safety
| Toxicity | There is no experience with overdosage of trastuzumab in clinical trials - single doses >8 mg/kg have not been tested in humans.Trastuzumab can contribute to the development of ventricular dysfunction and congestive heart failure, particularly when used in combination (or temporally adjacent) to other cardiotoxic chemotherapies such as anthracyclines. |
|---|
- High-dose exposure has not been characterized
- Human data above 8 mg/kg are lacking, so toxicological margins remain undefined
- Known risk for cardiotoxicity, including ventricular dysfunction and congestive heart failure, which is potentiated by concomitant or sequential anthracycline use
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Trastuzumab 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.
Trastuzumab (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.
Trastuzumab API manufacturers & distributors
Compare qualified Trastuzumab API suppliers worldwide. We currently have 5 companies offering Trastuzumab API, with manufacturing taking place in 5 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 | CoA, GMP, USDMF | 229 products |
| Biocon | Producer | India | India | CoA, GMP | 36 products |
| Celltrion | Producer | South Korea | South Korea | CoA, JDMF | 2 products |
| LGM Pharma | Distributor | United States | United States | CoA, GMP, USDMF, WHO-GMP | 441 products |
| Sandoz | Producer | Austria | Austria | CoA, GMP | 58 products |
When sending a request, specify which Trastuzumab API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Trastuzumab API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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