Pharmaceutical Analytics for Antibody Therapeutic Development

During therapeutic antibody production, global regulatory requirements help ensure that the products are safe, effective, and high-quality. These requirements, guided by global regulatory agencies, pharmacopeias, ICH, and other bodies, involve a comprehensive range of tests and analyses throughout the development and manufacturing processes.

Thermo Fisher Scientific has an extensive portfolio of analytical testing solutions supporting the therapeutic antibody manufacturing workflow. The Applied Biosystems SEQ solutions employ rapid, highly sensitive, and specific molecular assays designed to quantify impurities, and detect and identify contaminants. Our analytical solutions offer same-day results, often in less than 5 hours, which are vital in efficiently developing and controlling manufacturing processes while helping to meet with regulatory requirements for lot-release testing.