Increasing number of potent therapeutic protein modalities with extremely low First-in-Human doses (< 0.1 ug/kg ) are under development in recent years. Developing a robust drug product strategy that enables accurate delivery of these potent drugs is critical for patient safety and product efficacy. The presentation discusses the pharmaceutical development challenges, from formulation to product in-use, encountered in the development of potent biologics drug products. The strategies implemented can potentially guide development of similar products requiring ultra-low clinical doses.
Disclosures: All authors are employees of AbbVie. The design, study conduct, and financial support for this research were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication.
Upon completion, participant will be able to understand the overall challenges involved in developing ultra-low dose drug products with a focus on biologic therapeutics
Upon completion, participant will be able to understand the analytical tools required in developing low dose drug products and the special in-use approaches required
Upon completion, participant will be able to employ necessary tools to assess the risk involved in CMC development of these low dose drug products