Tisagenlecleucel API Manufacturers

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Looking for Tisagenlecleucel API 1823078-37-0?

Description:
Here you will find a list of producers, manufacturers and distributors of Tisagenlecleucel. You can filter on certificates such as GMP, FDA, CEP, Written Confirmation and more. Send inquiries for free and get in direct contact with the supplier of your choice.
API | Excipient name:
Tisagenlecleucel 
Synonyms:
Adoptive immunotherapy agent CTL019 , CAR.CD19-Redirected T cells , Tisagenlecleucel-T  
Cas Number:
1823078-37-0 
DrugBank number:
DB13881 
Unique Ingredient Identifier:
Q6C9WHR03O

General Description:

Tisagenlecleucel, identified by CAS number 1823078-37-0, is a notable compound with significant therapeutic applications. Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy, or a CAR-T cell therapy for B-cell acute lymphoblastic leukemia. It was granted approval by FDA in August 2017 under the market name Kymriah. Tisagenlecleucel is an immunocellular therapy that involves autologous T cells that are collected from each individual patient and genetically engineered to express a specific protein called a chimeric antigen receptor (CAR) that specifically target CD19 antigens. Modified T cells are infused back into the patient's body. These CD19-directed chimeric antigen receptors (CD19 CAR-T cells) direct the T cells to target and kill leukemia cells that express CD19 on the cell surface. In a multicenter clinical trial involving pediatric and young adult patients with relapsed or refractory B-cell precursor ALL, the overall remission rate within three months of treatment was 83 percent.

Indications:

This drug is primarily indicated for: Tisagenlecleucel is indicated for use in individuals aged 25 years and younger with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. It is also used to treat adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Tisagenlecleucel is also indicated in adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Absorption:

The absorption characteristics of Tisagenlecleucel are crucial for its therapeutic efficacy: In pediatric and young adult relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) patients receiving tisagenlecleucel infusion, the mean peak plasma concentration was approximately 34,700 copies/mcg with a median time of 9.91 days to reach this value (Tmax). The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Tisagenlecleucel is an important consideration for its dosing schedule: The mean half life was 16.8 days in pediatric and young adult relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) patients. This determines the duration of action and helps in formulating effective dosing regimens.

Volume of Distribution:

Tisagenlecleucel is distributed throughout the body with a volume of distribution of: The drug is found to be distributed in the blood as well as the bone marrow. Blood to bone marrow partitioning suggested that tisagenlecleucel distribution in bone marrow was 44% of that present in blood at Day 28 while at Months 3 and 6 tisagenlecleucel distributed at 67% and 69%, respectively, indicating high distribution to bone marrow. This metric indicates how extensively the drug permeates into body tissues.

Pharmacodynamics:

Tisagenlecleucel exerts its therapeutic effects through: Tisagenlecleucel demonstrates efficacy in re-inducing remission in patients with refractory B-cell precursor acute lymphoblastic leukemia. The sole purpose of the therapy is to eliminate CD19-expressing malignant and normal cells with specificity and increased chance of remission. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Tisagenlecleucel functions by: Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy that involves genetically modified autologous T cells isolated from each individual patient. The reprogramming of the patient's T cells uses a lentiviral vector to encode an anti-CD19 chimeric antigen receptor (CAR). The CAR is comprised of a murine single-chain antibody fragment (scFv) specific for CD19, followed by a CD8 hinge and transmembrane region that is fused to the intracellular signaling domains from 4-1BB (CD137) and CD3 zeta. These intracellular costimulatory signaling domains increase the expansion, longer-term persistence and potency of CAR T cells; the CD3 zeta component is critical for initiating T-cell activation and antitumor activity, while 4-1BB enhances the expansion and persistence of tisagenlecleucel. Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T-cell expansion, activation, target cell elimination, and persistence of the tisagenlecleucel cells. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Categories:

Tisagenlecleucel is categorized under the following therapeutic classes: Amino Acids, Peptides, and Proteins, Antineoplastic Agents, Antineoplastic Agents, Immunological, Antineoplastic and Immunomodulating Agents, Cancer immunotherapy, CD19 Receptor Interactions, CD19-directed Chimeric Antigen Receptor, Genetically-modified Autologous T Cells, Immunotherapy, Membrane Proteins, Proteins, Receptors, Antigen. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.

Tisagenlecleucel 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.