FDD: Solid Dose Formulation Challenges
Thursday, November 1 2012
8:00 am – 10:00 am
Location: MassBio, 300 Tech Square, 8th Floor, Cambridge
Implementation of Statistical Designs in Understanding the Effect of Formulation and Process Variables on Product Quality
Speaker: Bhavishya Mittal, Ph.D., Millennium: The Takeda Oncology Company
A formulation scientist is typically faced with numerous challenges when it comes to applying statistical design in their work. For example, during early formulation development, a mixture design approach is appropriate. However, as the formulation is locked and the process is scaled-up, a cubical design space approach is preferred. This presentation will discuss some of the approaches that have been taken at Millennium Pharmaceuticals to better understand which statistical design should be applied in various situations and how to better understand the interactive effect of formulation and process variables on product quality.
The Myth of Powder Flowability
Speaker: Tian Hao, Ph.D., Neo-Advent Technologies LLC
Powder flowability is a very important classic topic in pharmaceutical solid dosage formulations. A general review of powder flowability will be presented on the basis of recent research and development work reported in literature. The powder flowability characterization methods such as shear test and flowdex measurements will be evaluated. More importantly, a systematical investigation on the correlation of powder flowability with physical properties of powder materials, like powder particle size, electrostatic charge, and tap density, among other factors, will be addressed. Neo-Advent Technologies is currently working to develop more practical approaches for characterizing powder flowability and implementing them in optimized product development.
Transforming Pharmaceutical Manufacturing Continuous: The Ultra Lean Way of Manufacturing
Speaker: Dr. James Evans, Associate Director, Novartis-MIT Center for Continuous Manufacturing
We describe the motivation for and vision behind continuous manufacturing. In particular, we discuss continuous manufacturing as the ultimate in lean manufacturing with quantified and fully integrated processes. We also present a cost analysis based on a basic case study, and the potential impact on the supply chain from a pure cost perspective. We also discuss the challenges and how to address them.
Dr. James Evans, Associate Director, Novartis-MIT Center for Continuous Manufacturing
Dr. Evans is currently the Associate Director at the Novartis-MIT Center for Continuous Manufacturing. In this role he has responsibility for delivering the first of its kind bench scale Integrated Continuous Manufacturing platform that can be utilized as a model and learning tool for transforming the pharmaceutical manufacturing paradigm. In addition to this, Dr. Evans is leading an effort to understand how these paradigm shift will impact the overall supply chain and its potential to impact/benefit patients. Dr. Evans is also leading a number of technical teams that are working on the translation and application of blue-sky technologies that have been developed at MIT. Dr. Evans received his Ph.D. in Chemical and Process Engineering from Herriot Watt University and an MS in Instrumentation and Analytical Chemistry from UMIST. Dr. Evans has extensive experience in API pharmaceutical manufacturing and R&D for both MNC’s and biotech companies.