An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US

Advanced pharmaceutical manufacturing: A functional definition

“…[ 75 ] In spite of this perception a recent FDA internal audit found that products with CM processes tended to be approved in less time and reach the market sooner. [ 11 ] The proposed definition of APM also seeks to contribute to regulatory approval of new products by manufacturing products with equivalent CQAs and minimizing patient risk.…”

“…Currently, some policy makers seek to promote the use of APM for various purposes, including: re‐shoring of pharmaceutical manufacturing as a national security issue, [ 6 ] promoting economic development and creation of high paying manufacturing jobs, [ 9 ] addressing drug shortages, [ 8,10,11 ] preparing the country for future medical emergencies. [ 6,9,11,12 ] the protection of patients from fake and diverted products. [ 13–16 ] and the production of high quality medications.…”

“…re-shoring of pharmaceutical manufacturing as a national security issue, [6] 2. promoting economic development and creation of high paying manufacturing jobs, [9] 3. addressing drug shortages, [8,10,11] 4. preparing the country for future medical emergencies. [6,9,11,12] 5. the protection of patients from fake and diverted products. [13][14][15][16] 6. and the production of high quality medications.…”

Kinetic modelling of an environmentally friendly carbamazepine synthesis via urea and iminostilbene in batch and continuous processes

“…[1][2][3][4][5] The recent CM approvals of drug products from FDA are primarily focused on drug product manufacturing for solid oral dosage forms, yet the momentum is growing toward further expansion of CM technology to upstream processes including the synthesis of active pharmaceutical ingredients (APIs). 6 Continuous API synthesis can be achieved by flow chemistry using continuous flow reactors. Small scale continuous flow reactors are known to have faster mixing times as well as better temperature control in comparison to batch reactors due to their higher surface area to volume ratio.…”

Magnetic separation of immobilized biocatalyst enables continuous manufacturing with a solids-forming reaction

“…Continuous manufacturing offers several advantages over batch-wise processes, including increased system control and reduced variation in product quality, and could provide substantial improvements for larger manufacturing processes in the pharmaceutical arena. [1][2][3][4][5][6] The success of recent efforts to move commercial production, at least in part, to a continuous setup is promising, 1,5,7-14 but additional work is needed. Design of new, continuous unit operations will enable end-to-end continuous manufacturing, especially for challenging chemistries such as the solids-catalyzed, solids-forming reactions emphasized in this study.…”