Technical / White Paper
Guiding Development of Novel Drugs
Increased use of therapeutic proteins such as monoclonal antibodies, engineered proteins and other biological products has resulted in a growing number of biotherapeutic drugs. New biotherapeutic drugs bring tremendous advancement in the treatment of a number of diseases. To ensure the safety of patients, immunogenicity studies must be employed. The development of anti-drug antibodies can cause allergic or serious side effects. Good study design and well characterized methods must be employed to carefully detect and evaluate unwanted immunogencity in order to protect patients