Therapeutic proteins can sometimes elicit a harmful immune response, compromising patient health and product efficacy. In response to this, FDA recently issued draft guidance entitled, “Immunogenicity Assessment for Therapeutic Proteins,” aimed to assist manufactures and clinical investigators in the development of risk assessment strategies for therapeutic protein products, per an article from in-pharmatechnologist.com. In the guidelines, FDA recommends sponsors to take a risk based approach method to assess the immune response to therapeutic proteins and establish clinical phase risk mitigation strategies. According to FDA, the guidance will encourage the development of therapeutic proteins, since risk factors and risk management strategies will identified early on. To read the full article on in-pharmatechnologist.com, click here. Contact us at 317-899-9341 if you need help with a protein therapeutic clinical study.
