Overcoming the Challenges in Biopharmaceutical Stability Testing

May 6, 2013
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

As pharmaceutical and biopharmaceutical companies intensify product development in biologics, they are tasked with meeting the challenges of biologic-based drug development and manufacturing.

 

As pharmaceutical and biopharmaceutical companies intensify product development in biologics, they are tasked with meeting the challenges of biologic-based drug development and manufacturing. Unlike traditional small-molecule drugs, stability studies for biopharmaceuticals can be one of the most critical and challenging aspects of large-molecule drug development. The size and complexity of most proteins provide fertile ground for intramolecular changes and multiple routes of degradation, and to assess their effects, each must be correlated to the bioactivity of the drug. Pharmaceutical Technology will examine biopharmaceutical stability studies in more depth by gaining input from leading industry experts, in a live webcast, “New Strategies for Biopharmaceutical Stability Testing,” on Thursday May 9th from 2:00 to 3:00 PM EST.

With the average cost to develop a biopharmaceutical well over $1 billion, and shelf life being an important driver of success, understanding these effects prior to long-term stability profiling is crucial to sound decision-making and efficient development strategy. This 60-minute webcast will provide insight from leading industry experts on the common pitfalls of biopharmaceutical stability testing, regulatory agencies’ expectations for supporting data, and the analytical techniques that can improve information and streamline the development process.

The panelists for the webcast will be: John Geigert, PhD., RAC, president of BioPharmaceutical Quality Solutions, and past member of the PDA Board of Directors, past co-chair of the PDA Biotech Advisory Board and past expert member of the USP Biotechnology Committee; Carrie L. Anderson, senior scientist from Merck & Co; and John C. Anders, PhD, senior scientific advisor, ABC Laboratories.

The free webcast is open to audience members, who may pose questions to the panelists in a Q&A session following the presentations by the panelists. Information on how to register for the live event for Thursday May 9th from 2:00 to 3:00 PM EST or for on-demand viewing is available here.

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