Integrating Nanotechnology into the Life Sciences: Lessons Learned

As the incorporation of nanomaterials in the life science industries becomes more prevalent, the need to understand the mechanisms behind their properties becomes paramount. A critical element of Quality by Design (QbD) is to identify Critical Quality Attributes (CQAs) associated with performance. Due to the challenges in analyzing these innovative materials, CQAs are often difficult to pinpoint. Through the use of case studies, this informative seminar will provide insights and lessons learned from numerous nanomaterials characterization projects where sample properties were evaluated to better understand their mechanisms. These lessons address a broad spectrum of topics ranging from sample collection and analysis to the rapidly evolving U.S. EPA and FDA regulatory landscape.

Four case studies will be shared and will serve to highlight the lessons learned in various applications of nanotechnology. Quantum dot analysis will highlight the many facets that need to be considered when dealing with nanomaterial characterization, including sample preparation and characterization techniques. Critical issues surrounding quality assurance in nanomaterial manufacturing will be illustrated using gold and silver nanoparticle examples. Evaluation of a point-of-care (POC) diagnostic biosensor will highlight potential impact of analysis on product design and will allow for discussion of modeling and simulations. Lastly, examples of carbon nanotube evaluation will serve to demonstrate the utility of interdisciplinary analysis as well as highlight the regulatory issues encountered with the use of nanomaterials. Through these shared experiences, a comprehensive picture will emerge of what is entailed in resolving the analytical challenges when integrating nanotechnology into the life sciences.

Take Home Benefits

Attendees will be exposed to four case studies and discover the lessons learned in each experience. Through these lessons, they will realize a greater understanding of the challenges facing those utilizing nanotechnology in their products.

Who Should Attend

Staff from Biotechnology, Biomedicine, Pharmaceutical and related Life Science industries and regulatory agencies involved in Research and Development, Product and Process Development, Quality Assurance, Quality Control, and Regulatory Affairs.

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