Integrated Solutions for Biologics Formulation and Drug Product Development
Summary: There are many challenges to conduct thorough drug product formulation development at early stage drug substance process development. Those challenges include material limitation, suitable analytical method, time and labor cost. Sufficient development of the right formulation and dosage form for biologics products early on helps to avoid formulation redevelopment and change during the later stage of product development, which leads to additional analytical, pharmacokinetics or even clinical comparability studies. In this webinar series hosted by BioProcess International, Yunsong (Frank) Li, Director of Process Development at Catalent highlights a fast track pathway to the clinic.