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Simlukafusp alfa | CAS No: 1776942-10-9 | GMP-certified suppliers
A medication that supports immunotherapy combination regimens for treating metastatic pancreatic ductal adenocarcinoma in clinical trial settings.
Product Snapshot
- Simlukafusp alfa is an injectable recombinant fusion protein
- It is primarily being developed for oncology indications
- The product is currently investigational and not yet approved by regulatory authorities
Clinical Overview
Detailed information regarding the clinical indication, pharmacodynamics, and mechanism of action of simlukafusp alfa has not been disclosed in the available data. Likewise, the drug’s absorption, distribution, metabolism, and excretion (ADME) characteristics remain unspecified at this stage of development.
As an experimental entity, simlukafusp alfa has not received regulatory approval and should be considered a research compound. Safety and toxicity profiles have not been publicly reported, and comprehensive evaluation through ongoing and future clinical studies is required to establish these parameters.
Due to the investigational status of simlukafusp alfa, no branded formulations are currently marketed. Its use is limited to controlled clinical trial settings, primarily focusing on immunotherapy strategies for hard-to-treat pancreatic malignancies.
From an API sourcing and quality perspective, procurement should ensure compliance with Good Manufacturing Practice (GMP) standards to support clinical trial requirements. Analytical characterization, purity assessment, and rigorous quality control are critical considerations given the compound’s investigational use and the sensitivity of immunotherapeutic applications. Robust documentation and traceability will facilitate regulatory submissions and eventual clinical development milestones.
Identification & chemistry
| Generic name | Simlukafusp alfa |
|---|---|
| Molecule type | Biotech |
| CAS | 1776942-10-9 |
| UNII | FL08SGO9XA |
| DrugBank ID | DB16092 |
Formulation & handling
- Simlukafusp alfa is a biotech investigational agent primarily intended for parenteral administration.
- As a biologic modality, it requires controlled temperature storage to maintain stability.
- Handling should minimize agitation and exposure to light to preserve product integrity.
Regulatory status
Simlukafusp alfa is a type of Anticancer drugs
Anticancer drugs belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category designed specifically to combat cancer cells. These powerful medications play a crucial role in cancer treatment and are developed to target and destroy cancerous cells, preventing their growth and spread.
Anticancer drugs are classified based on their mode of action and can include various types such as chemotherapy drugs, targeted therapy drugs, immunotherapy drugs, and hormonal therapy drugs. Chemotherapy drugs work by interfering with the cell division process, thereby inhibiting the growth of cancer cells. Targeted therapy drugs, on the other hand, are designed to attack specific molecules or genes involved in cancer growth, minimizing damage to healthy cells. Immunotherapy drugs stimulate the body's immune system to recognize and destroy cancer cells. Hormonal therapy drugs are used in cancers that are hormone-dependent, such as breast or prostate cancer, to block the hormones that fuel cancer cell growth.
These APIs are typically synthesized through complex chemical processes in state-of-the-art manufacturing facilities. Stringent quality control measures ensure the purity, potency, and safety of these drugs. Anticancer APIs undergo rigorous testing and adhere to stringent regulatory guidelines before being approved for clinical use.
Due to their critical role in cancer treatment, anticancer drugs are in high demand worldwide. Researchers and pharmaceutical companies continually strive to develop new and more effective APIs in this category to enhance treatment outcomes and minimize side effects. The ongoing advancements in the field of anticancer drug development offer hope for improved cancer therapies and better patient outcomes.
Simlukafusp alfa API manufacturers & distributors
Compare qualified Simlukafusp alfa API suppliers worldwide. We currently have 1 companies offering Simlukafusp alfa API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Blue Eyes Biotech Co., Lt... | Producer | United Kingdom | United Kingdom | CoA | 35 products |
When sending a request, specify which Simlukafusp alfa 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 Simlukafusp alfa 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.
