<0.001 EU per 1 μg of the peptide by the LAL method
10000000 unit / mL
For treatment of venereal or genital warts caused by the Human Papiloma Virus
Examples of Clinical Use:
Venereal or genital warts
Upregulates the expression of MHC I proteins, allowing for increased presentation of peptides derived from viral antigens. This enhances the activation of CD8+ T cells that are the precursors for cytotoxic T lymphocytes (CTLs) and makes the macrophage a better target for CTL-mediated killing. The product also induce the synthesis of several key antiviral mediators, including 2'-5' oligoadenylate synthetase (2'-5' A synthetase) and protein kinase R.
Mechanism of action:
Interferon alpha binds to type I interferon receptors (IFNAR1 and IFNAR2c) which, upon dimerization, activate two Jak (Janus kinase) tyrosine kinases (Jak1 and Tyk2). These transphosphorylate themselves and phosphorylate the receptors. The phosphorylated INFAR receptors then bind to Stat1 and Stat2 (signal transducers and activators of transcription)which dimerize and activate multiple (~100) immunomodulatory and antiviral proteins. Interferon alpha binds less stably to type I interferon receptors than interferon beta.
Interferon alfa-n1 is a synthetic version of the human interferon alpha-2a protein. The development of interferon alfa-n1 can be traced back to the discovery of interferons and their potential therapeutic uses. The discovery of interferons can be credited to the work of Alick Isaacs and Jean Lindenmann in the late 1950s and early 1960s. They observed that cells infected with a virus produced a substance that could protect non-infected cells from viral infection. This substance was named interferon, as it interfered with viral replication. Following the discovery of interferons, researchers began exploring their potential therapeutic applications. They found that interferons had antiviral and immunomodulatory properties, making them promising candidates for the treatment of viral infections and certain cancers.
In the 1980s, the genetic engineering techniques developed by biotechnology companies made it possible to produce synthetic versions of interferons. This led to the production of different types of interferons, including interferon alfa-2a, which is the parent molecule of interferon alfa-n1. Interferon alfa-n1 was developed by genetic modification of interferon alfa-2a to generate a protein with enhanced antiviral activity. It was specifically designed to have superior antiviral efficacy against certain strains of viruses, particularly hepatitis B and C. The development of interferon alfa-n1 involved extensive laboratory research, including studying its mechanism of action, efficacy, and safety profile. Preclinical and clinical trials were conducted to evaluate its effectiveness and establish the optimal dosage and treatment duration for various conditions.
The production of interferon alfa-n1 involves recombinant DNA technology, where the gene encoding interferon alpha-2a is inserted into host cells, such as bacteria or yeast. These cells are then cultured and engineered to produce large quantities of the protein, which is subsequently purified and formulated into the final medication. Throughout its development, interferon alfa-n1 has undergone rigorous testing and regulatory approval processes to ensure its safety and efficacy. Today, interferon alfa-n1 is commercially available and is used as a therapeutic option for chronic hepatitis B and C infections, certain types of cancer, and other related conditions. Ongoing research continues to explore its potential applications and improvements in treatment regimens.
2. Synthetic pathway of Interferon alfa-n1
The synthesis of Interferon alfa-n1 involves recombinant DNA technology and the use of host cells to produce the protein. Here is a general outline of the synthetic pathway:
Identification of the gene: The gene encoding Interferon alfa-n1 is isolated and identified. This gene contains the genetic instructions for the synthesis of the protein.
Gene insertion: The gene is then inserted into suitable host cells, such as bacteria or yeast. Various methods, like plasmid vectors or viral vectors, can be used for gene insertion.
Cell culture and expression: The host cells containing the inserted gene are cultured in a controlled environment, such as a bioreactor. The cells are provided with the necessary nutrients and conditions for growth and protein expression.
Protein production: Inside the host cells, the inserted gene is transcribed and translated into the Interferon alfa-n1 protein. The host cells act as mini-production factories, producing large quantities of the protein.
Protein purification: After the protein is produced, the host cells are harvested, and the Interferon alfa-n1 protein is extracted. This extraction involves several purification steps, such as filtration, chromatography, and centrifugation, to obtain a highly pure and concentrated protein.
Formulation and packaging: The purified Interferon alfa-n1 protein is then formulated into a suitable pharmaceutical product, such as a solution or lyophilized powder. It is packaged into vials or other appropriate containers, ensuring sterility and stability during storage.
Quality control and testing: The final Interferon alfa-n1 product undergoes extensive quality control testing to ensure its safety, potency, purity, and stability. This includes testing for impurities, assessing its bioactivity, and evaluating its physical and chemical properties.
Regulatory approval: Before the synthetic Interferon alfa-n1 product can be marketed and used clinically, it must go through regulatory approval processes. These processes vary from country to country and involve demonstrating the product's safety and efficacy through preclinical and clinical trials.
Once approved, the synthetic Interferon alfa-n1 product can be made available for medical use in the treatment of various conditions, such as chronic hepatitis B and C infections and certain types of cancer. Ongoing research and development efforts continue to improve the production process and optimize the therapeutic properties of Interferon alfa-n1.
3. Clinical effect of Interferon alfa-n1
Interferon alfa-n1 is a type of protein known as interferon-alpha, which has several clinical effects in the body. Here are some of the clinical effects of Interferon alfa-n1:
Antiviral activity: Interferon alfa-n1 has potent antiviral activity and is effective against certain viral infections. It can inhibit the replication of viruses, such as hepatitis B and C viruses, which can help reduce viral load and slow down the progression of the infection.
Immunomodulatory effects: Interferon alfa-n1 has immunomodulatory properties, meaning it can regulate and balance the immune response. It can enhance the immune system's ability to recognize and destroy infected or cancerous cells, improving the body's natural defense mechanisms.
Antiproliferative effects: Interferon alfa-n1 has been shown to have antiproliferative effects on cells, particularly cancer cells. It can inhibit the growth and division of cancerous cells, leading to tumor regression or slower tumor progression.
Antitumor effects: Interferon alfa-n1 is used in the treatment of certain types of cancer. It can directly target cancer cells, induce programmed cell death (apoptosis), and inhibit the formation of blood vessels that supply tumors with nutrients.
Anti-inflammatory effects: Interferon alfa-n1 can also have anti-inflammatory effects. It can reduce inflammation in certain autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis, by modulating the immune response and suppressing inflammatory mediators.
Adjunct therapy in certain conditions: Interferon alfa-n1 is used as an adjunct therapy in various conditions, either alone or in combination with other medications. It can enhance the effectiveness of other antiviral or anticancer treatments and improve treatment outcomes.
Clinical use of Interferon alfa-n1 is dependent on the specific condition being treated and is determined by healthcare professionals. The dosage and treatment duration vary based on the individual patient's needs and response. It is important to note that Interferon alfa-n1 may have side effects and contraindications, and its use should be carefully monitored and guided by healthcare professionals.
For research use only. Not intended for any clinical use. No products from Creative BioMart may be resold, modified for resale or used to manufacture commercial products
without prior written approval from Creative BioMart.
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