DATE/TIME
September 27, 09:00 – 09:30 AM EST
TITLE
Accelerated Development & Tech Transfer of Continuous Manufacturing Processes
SPEAKER
Dr. James Scicolone
ABSTRACT
In the last few years, continuous manufacturing methodologies have gained significant popularity among branded pharmaceutical companies. As of a year ago (last data available) FDA had approved 16 continuous manufacturing (CM) applications and had more than 40 accepted by the ETT. Moreover, CM has expanded its scope to include not only oral solid dose products (the original application) but also API, injectables, and biologics.
This rapid growth in regulatory applications indicates that in the next few years, a large volume of new products, estimated to exceed in value $20 billion per year, will be manufactured using CM methods. However, implementation of new CM lines appears to lag behind the growth of regulatory applications, indicating a likely lack of in-house installed capacity. This represents a substantial opportunity for CMOs that can become specialized in implementing and operating CM processes.
In this talk, I will describe the main in-house capabilities required to successfully operate CM processes at a CMO organization. I will discuss an approach that can significantly accelerate the development and transfer to commercial manufacturing of CM processes, based on the implementation of mirror lines for development and GMP manufacturing.
BIO
Dr. Fernando J. Muzzio is a distinguished Professor of Chemical and Biochemical Engineering at Rutgers University. He is the director of the National Science Foundation Engineering Research Center on Structured Organic Particulate Systems. Dr. Muzzio is also the previous chair of the faculty of the National Institute for Pharmaceutical Technology and Education (NIPTE), which he co-founded in 2004. Dr. Muzzio is also the director of the Rutgers/Janssen partnership in Advanced Manufacturing. Fernando Muzzio is also the president of Integra Continuous Manufacturing Systems, a supplier of comprehensive consulting services in continuous manufacturing (www.integracms-pharma.com), and the Chief Scientific Officer of Acumen Biopharma.
In all of these roles, for the past 20 years, Dr. Muzzio has focused on continuous manufacturing of pharmaceutical products, working with many companies in developing and implementing continuously manufacturing products.
