Integrated Solutions for Biologics Formulation and Drug Product Development

This webcast features: Dr. Yunsong (Frank) Li, Director of Process Development, Catalent Biologics

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. To combat these challenges, this presentation will discuss:

  • How the use of a high throughput analytical platform and automated plate-based format for formulation screening can enable 96 formulations in only six weeks
  • How to move the molecular candidate quickly to the drug product manufacturing stage using a process based on platform container closure systems and platform manufacturing technology
  • How the integration of these platforms enabled a fast track pathway for a biologic molecule from discovery through drug product fill/finish to the clinic

Watch the recorded webcast below.

Learn more about Catalent in this Q&A with Dr. Jun Lu, Director, Analytical Development
A Strategy to Remove Formulation Development from the Critical Path During Biologics Development

Leave a Reply