Antibody production for clinical use involves several steps to ensure high-quality antibodies that are safe, effective and consistent. This includes extensive quality control testing throughout the process to detect contamination that could compromise safety, stability or function. In addition, X-ray crystallography, nuclear magnetic resonance spectrometry and mass spectrometry are used to analyze the molecular structure of antibodies, which provides critical insight into their binding affinity, conformation and overall structural integrity.

During the upstream process, B cells are isolated from an animal, typically a mouse, and fused with immortal myeloma cells (cancerous cancer cells that can divide indefinitely to provide a continuous source of antibody-producing B cells). The hybridomas produce monoclonal antibodies in culture medium, which is then screened for the desired mAb using techniques like enzyme-linked immunosorbent assay and flow cytometry. Once the mAb is identified, it can be expanded in culture and large quantities of the monoclonal antibody can be produced.

Antibody Production for Clinical Use: Ensuring Safety and Efficacy

The mAb produced in the culture medium is subjected to several purification processes to isolate and remove impurities. Protein A affinity chromatography, ion exchange chromatography, and hydrophobic interaction chromatography are all used to separate the desired mAb from contaminants. Various formulation techniques are also employed to translate the crude antibody mixture into a formulated, ready-to-use product.

The final formulated monoclonal antibody is sterilized, labeled, and packaged under sterile conditions for clinical use. Sterility, cytotoxicity and endotoxin tests are also performed to ensure the safety of the monoclonal antibody product.