Equipment and Analytical Companies Meeting Continuous Challenges May 20–21 2014 Continuous Manufacturing Symposium

Enabling precision manufacturing of active pharmaceutical ingredients: workflow for seeded cooling continuous crystallisations

“…This also extends to equipment interfaces, ancillaries and control systems leading to bespoke systems. 12…”

“…Conventional approaches for obtaining consistent crystals with CQAs can struggle with batch-to-batch variability, 9,10 particularly at manufacturing scale. In addition, batch configurations have associated scale-up challenges 11,12 when moving from development to production.…”

Development and characterisation of a cascade of moving baffle oscillatory crystallisers (CMBOC)

“…Continuous manufacturing has attracted considerable attention as an efficient route to convert raw materials into safe, effective and high quality pharmaceutical products. 1,2 In the production of drug substance, the crystallisation process is essential to deliver purity as well as achieving consistent particles with desirable quality attributes including size, shape and form that in turn impact manufacturability, stability and performance. With increasing interest in the industrial adoption of continuous manufacturing, there is a need for robust, well characterised continuous crystallisation process equipment.…”

The Future of Pharmaceutical Manufacturing Sciences

“…An example of it are novel manufacturing methods (e.g., based on continuous flow chemistry) that are now being introduced by industry, academia, and regulators . The recently published white paper series from the MIT‐Strathclyde symposium on continuous manufacturing (CM) in 2014 highlights the current state of thinking . Moreover, the ICH is in the process of developing a new guideline (ICH Q12) that can serve as basis for implementing CM across the industry in a widespread manner.…”

“…[7][8][9] The recently published white paper series from the MIT-Strathclyde symposium on continuous manufacturing (CM) in 2014 highlights the current state of thinking. [10][11][12][13][14][15][16][17][18] Moreover, the ICH is in the process of developing a new guideline (ICH Q12) that can serve as basis for implementing CM across the industry in a widespread manner.…”