Pharmaceutical Manufacturing in the 21st Century-From Batch to Continuous Manufacturing-An FDA Perspective


15th June 2016 | 9AM EST | Dr Sau (Larry) Lee, FDA |WATCH FOR FREE

The FDA’s Office of Pharmaceutical Quality (OPQ) is working to encourage the development and adoption of emerging technologies in the pharmaceutical industry that have potential to enhance drug product quality. To achieve this goal, OPQ established the emerging technology team (ETT) program and focuses on advancing regulatory science for emerging technologies. OPQ has identified Continuous Manufacturing as one such emerging technology which has the potential to increase the efficiency, flexibility, agility, and robustness of pharmaceutical manufacturing. The ETT provides industry early engagement opportunities with FDA to receive feedback on potential technical and regulatory issues and FDA’s recommendations for regulatory submission content related to continuous manufacturing and other emerging technologies. In addition, OPQ has started a regulatory science and research program on continuous manufacturing to address remaining gaps in our knowledge and experience. Our research program is currently focused on the following areas in (1) integrated process modeling, (2) understanding of the impact of material properties, and (3) implementation of advanced process control strategies and real time release testing. The results and knowledge developed in this program can be utilized to support the implementation of continuous manufacturing and to ensure that FDA regulatory policies reflect state-of-the-art manufacturing science.

 

Presenter

Microsoft Word - Bio.docDr Sau (Larry) Lee is currently the acting Associate Director for Science of the Office of Pharmaceutical Quality (OPQ), the acting Team Leader of the OPQ Botanical Review Team, and the chair of the OPQ Emerging Technology Team. Larry and his OPQ Scientific and Research Staff are leading the effort in advancing OPQ research and in manufacturing science, complex drug substances and products containing nanomaterials, as well as in developing the regulatory policy, scientific standards as well as computational and modeling tools supporting quality review and inspection in OPQ.

 

Sponsored by Thermo Fisher Scientific

TS_logo_2c_tag_jpg

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $17 billion and more than 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.

 

Dirk_Leister_smallDirk Leister is the head of the application team for extruders and compounders at Thermo Fisher Scientific in Karlsruhe, Germany. The team focuses on applications for extrusion-based processes used in the pharmaceutical, food, and polymer industries. Dirk holds an engineering degree in biotechnology and started his professional career in pharmaceutical research and development. After moving to the instrument manufacturing side of the industry, he had several positions in technical sales and product management. His expertise is developing applications for process equipment used to conduct formulation research, process development and manufacturing scale-up for pharmaceutical and bulk material handling. Dirk is adept at helping companies minimize optimization time, costs and efforts of their continuous process scale-up.


We will not sell your information to a third party. See our Privacy Policy