欧美AV

Purpose of meeting

Continuous manufacturing offers great promise in improving productivity, efficiency and the intrinsic quality of pharmaceutical products. However, despite strong regulatory support aimed at encouraging the early adoption of new technologies, which in turn would facilitate the application of modern quality management techniques to all aspects of pharmaceutical production and quality assurance; uptake by Industry has been very slow. 
The first NDA approval using continuous manufacturing for a fixed dose combination tablet product, Orkambi庐 (lumacaftor/ivacaftor), was approved by the FDA and EMA during 2015. Prezista庐 was the first supplemental NDA approval (2016) for changing from an established batch process to a continuous manufacturing process.
This symposium will critically examine some of the challenges and opportunities that arise from adopting continuous manufacturing. Leading regulators, industrialists and academics will be sharing their experiences in the development, manufacturing and quality assurance of continuous manufacturing. 

Challenges:

• Why has industry been so slow to embrace this new approach to manufacturing?
• What are some of the regulatory challenges?
• What are some of the quality challenges, particularly from the perspective of the QP?
• What are some of the data challenges that arise in a 鈥渂ig data鈥� scenario?
• How do we ensure that our personnel are appropriately trained to allow them to move from 鈥渂atch鈥� to 鈥渃ontinuous鈥� manufacturing?
• What are some of the PAT applications to be found in a continuous manufacturing process? 

Opportunities:

Better understanding of continuous manufacturing and the advancement of PAT will ultimately result in real time release processes. Continuous manufacturing processes have a small footprint so engender more flexible use of space in the factory of the future. Continuous manufacturing can better cope with the peaks/troughs that routinely occur in a supply/demand market. 

Proposed outcomes:

You will gain the latest insights into the regulatory and manufacturing challenges that arise from continuously manufactured products and processes. You will better understand the critical role of chemometrics, PAT and at-line analysis for the continuous monitoring and control of these processes. You will be able to network with experts across industry, academia and the regulators.