Monoclonal antibodies are immunoglobulins produced in a laboratory setting that bind to specific antigens, such as epitopes expressed on the surfaces of cells. They can be used to treat various diseases, including some forms of cancer. Monoclonal antibodies are produced using hybridoma technology or the phage display technique. With hybridoma technology, immortalized tumor cells are hybridized with mammalian B cells that produce antibodies. Hybridoma cells undergo multiple rounds of screening and selection, and cell lines that produce mAbs with the highest specificities for target antigens are chosen for mAb production. The phage display technique involves cloning a mAb gene construct into cells that will express the recombinant protein in vitro. The gene construct is carried into cells by a vector, such as a plasmid or virus. Stable cell lines that produce mAbs with the desired specificities are then selected for mAb production.

qPCR applications in the process development phase

In the process development phase, mAb manufacturers develop assays, tests, and standard operating procedures (SOPs) that must be rigorously followed during preclinical and clinical trials and at the manufacturing stage. Generating reproducible data with reliable tools is essential for maintaining genetic consistency and regulatory compliance throughout mAb cell line and master cell line bank process development. It is thus important to adhere to current good manufacturing process (cGMP) principles and ensure that a robust quality control (QC) system is in place with documentation from all suppliers involved in the mAb development process.