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Leading The Change To Continuous Manufacturing Of Small Molecules
February 25, 2020
For more than a century, pharmaceuticals have been assembled through a systematic step-by-step process known as batch manufacturing. Continuous Manufacturing (CM) facilitates production of the final dosage form in a single nonstop process with no equipment downtime. Although different approaches are being taken, the goals are the same: promoting drug quality and improving the efficiency and yield of pharmaceutical manufacturing.
Today, with the support of CDER FDA, under the leadership of Janet Woodcock, MD, there are four companies manufacturing five FDA approved products using CM, treating diseases like cystic fibrosis, HIV-1 infections, breast cancer and leukemia. According to FDA, about 20 additional companies have engaged them to support their efforts to convert to CM.
Massachusetts has been at the forefront of this paradigm shift, with its home-grown companies and academic institutions developing and commercializing innovative continuous solutions. In this forum we’ll explore where we are and what’s next with Continuous Manufacturing of small molecules and what companies should be doing. We’ll also hear how CM has the potential to transform the entire discovery, development & manufacturing value chain from some visionary leaders.
This forum will focus on the following aspects of this ongoing industry transformation:
- What are the advantages/disadvantages of adopting continuous manufacturing? What is the risk of being left behind?
- What are the current barriers for implementation of continuous manufacturing?
- What is the Emerging Technologies Team (ETT) at CDER, and their role in CM?
- How should companies approach testing/adoption of this new platform?
- What is the role of supporting equipment, e.g., Process Analytical Technologies (PATs), and control systems?
- End-to-end – when will this happen?
- What is the larger vision for continuous flow technology and autonomous reaction platforms?