Bamlanivimab API Manufacturers

General Description:

Bamlanivimab, identified by CAS number 2423943-37-5, is a notable compound with significant therapeutic applications. Bamlanivimab (LY-CoV555, also known as LY3819253), is a synthetic monoclonal antibody (mAb) derived from one of the first blood samples in the United States from a patient who recovered from COVID-19. Bamlanivimab is a neutralizing IgG1κ mAb directed against the SARS-CoV-2 spike (S) protein, which is described to block viral entry into human cells. AbCellera initially discovered bamlanivimab in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), and subsequently further developed it in collaboration with Eli Lilly and Company. Bamlanivimab consists of two identical light chains of 214 amino acids and two identical heavy chains of 455 amino acids each; the Fc region is unmodified. Bamlanivimab is produced in Chinese Hamster Ovary (CHO) cells. Based on phase 2 clinical trial (BLAZE-1) interim results, bamlanivimab was granted Emergency Use Authorization (EUA) by the FDA on November 10, 2020. It is set to enter phase 3 clinical trials. Under the EUA granted in February 2021, bamlanivimab is used in combination with to treat mild to moderate COVID-19 in adults and pediatric patients who are at high risk for progressing to severe COVID-19: this EUA later expanded in December 2021 to include all younger children at high risk, including newborns. The EUA currently allows bamlanivimab and etesevimab for post-exposure prophylaxis of COVID-19 in adults and children.

Indications:

This drug is primarily indicated for: Bamlanivimab is not currently approved for any indication by the FDA. Bamlanivimab is authorized under an Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 in patients aged 12 years and older weighing at least 40 kg who are at high risk for progressing to severe COVID-19 and/or hospitalization due to COVID-19. Patients should have confirmed COVID-19, with identification of SARS-CoV-2 viral load by an approved test. Under this EUA, bamlanivimab is not authorized in patients who are hospitalized due to COVID-19, who require oxygen due to COVID-19, or in patients on oxygen therapy for non-COVID-19-related comorbidity who require an increased oxygen flow rate due to COVID-19. Bamlanivimab in combination with etesevimab is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. This combination regimen is also used for post-exposure prophylaxis of COVID-19 in unvaccinated or immunocompromised adults and pediatric individuals, including neonates, who are at high risk of progression to severe COVID-19, including hospitalization or death. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Bamlanivimab undergoes metabolic processing primarily in: As a monoclonal antibody, it is expected that bamlanivimab will be degraded by proteases in various locations throughout the body. Bamlanivimab is not metabolized by cytochrome P450 enzymes, making drug interactions unlikely. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Pharmacodynamics:

Bamlanivimab exerts its therapeutic effects through: Bamlanivimab is a recombinant human IgG1κ monoclonal antibody directed against the spike (S) surface protein of SARS-CoV-2. Patients in a phase 2 trial were administered up to 7000 mg (ten times the authorized dose) with no increase in treatment-related adverse effects and a flat exposure-response relationship over ranges of 700-7000 mg. Despite generally mild adverse effects noted in the phase 2 trial, there is a risk of serious infusion-related hypersensitivity reactions with bamlanivimab, including anaphylaxis, which may necessitate slowing the infusion rate or discontinuing treatment entirely. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Bamlanivimab functions by: Bamlanivimab is a neutralizing recombinant human IgG1κ monoclonal antibody directed against the spike (S) surface protein of SARS-CoV-2 derived from screening antigen-specific B-cells from a convalescent COVID-19 patient. X-ray crystallography and cryo-EM structural determination suggest that bamlanivimab binds the receptor-binding domain (RBD) of the S protein at a position overlapping the ACE2 binding site and which is accessible in both the up and down conformations of the RBD. Specifically, bamlanivimab binds to the S protein with a K_D of 0.071 nM and blocks S protein-ACE2 interactions with an IC₅₀ value of 0.025 μg/mL. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Classification:

Bamlanivimab belongs to the None, classified under the direct parent group Peptides. This compound is a part of the Organic Compounds, falling under the Organic Acids superclass, and categorized within the Carboxylic Acids and Derivatives class, specifically within the Amino Acids, Peptides, and Analogues subclass.

Categories:

Bamlanivimab is categorized under the following therapeutic classes: Amino Acids, Peptides, and Proteins, Anti-Infective Agents, Antibodies, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antiviral Agents, Blood Proteins, Experimental Unapproved Treatments for COVID-19, Globulins, Immunoglobulins, Immunoproteins, Proteins, Serum Globulins. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.

Experimental Properties:

Further physical and chemical characteristics of Bamlanivimab include:

• Molecular Weight: 146000.0
• Molecular Formula: C6498H10068N1732O2032S46