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Monoclonal antibody APIs are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance, or mimic the immune system's attack on cells. These antibodies are derived from a single clone of immune cells, ensuring that they are identical and specific to a particular antigen. Typically, they are produced using recombinant DNA technology and can be made from various sources, including mammalian cell cultures.
| Purity | Typically >95% |
| Form | Liquid or lyophilized powder |
| Storage temperature | 2°C to 8°C for liquid; -20°C for lyophilized |
| Concentration | 1 mg/mL to 100 mg/mL |
| Shelf life | 12 to 24 months |
When selecting monoclonal antibody APIs, buyers should consider the specific target antigen and the intended therapeutic application. It's important to specify the required purity levels, concentration, and any necessary certifications or regulatory compliance, such as cGMP. Additionally, buyers should indicate the desired quantities and any specific storage or handling requirements to ensure product integrity.
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They are used in therapies for cancer, autoimmune diseases, and infectious diseases.
They are produced using hybridoma technology or recombinant DNA technology.
The typical purity is greater than 95%.
They should be stored at 2°C to 8°C for liquid forms and -20°C for lyophilized forms.
The shelf life generally ranges from 12 to 24 months.
Yes, they often require compliance with cGMP and other regulatory standards.