Continuous Manufacturing of Recombinant Drugs: Comprehensive Analysis of Cost Reduction Strategies, Regulatory Pathways, and Global Implementation [PDF]
PharmaceuticalsThe biopharmaceutical industry is undergoing a fundamental transformation from traditional batch manufacturing to continuous manufacturing (CM) for recombinant drugs and biosimilars, driven by regulatory support through the International Council for ...
Sarfaraz K. Niazi
doaj +3 more sources
Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms [PDF]
Pharmaceutics, 2021 Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system.
John Wahlich
exaly +3 more sources
Development and Use of a Residence Time Distribution (RTD) Model Control Strategy for a Continuous Manufacturing Drug Product Pharmaceutical Process [PDF]
Pharmaceutics, 2022 Residence-time-distribution (RTD)-based models are key to understanding the mixing dynamics of continuous manufacturing systems. Such models can allow for material traceability throughout the process and can provide the ability for removal of non ...
Samantha Hurley +4 more
doaj +3 more sources
A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing [PDF]
Computers and Chemical Engineering, 2019 The Quality-by-Design (QbD) guidance issued by the US Food and Drug Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing practices including the adoption of continuous manufacturing.
Mariana Moreno +2 more
exaly +3 more sources
Scalable Continuous Manufacturing Process of Stereocomplex PLA by Twin-Screw Extrusion. [PDF]
Polymers (Basel), 2023 A scalable continuous manufacturing method to produce stereocomplex PLA was developed and optimized by melt-blending a 1:1 blend of high molecular weight poly(L-lactide) (PLLA) and high molecular weight poly(D-lactide) (PDLA) in a co-rotating twin-screw ...
Alhaj M, Narayan R.
europepmc +2 more sources
Transformative roles of digital twins from drug discovery to continuous manufacturing: pharmaceutical and biopharmaceutical perspectives. [PDF]
Int J Pharm XDigital Twins (DTs) represent a groundbreaking development tool in the pharmaceutical and biopharmaceutical industries, providing virtual representations of physical entities, processes, or systems.
Maharjan R, Kim NA, Kim KH, Jeong SH.
europepmc +2 more sources
Reactor design and selection for effective continuous manufacturing of pharmaceuticals. [PDF]
J Flow Chem, 2021 Pharmaceutical production remains one of the last industries that predominantly uses batch processes, which are inefficient and can cause drug shortages due to the long lead times or quality defects.
Hu C.
europepmc +2 more sources
An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US
International Journal of Pharmaceutics, 2022 Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times.
Sau Lee, Mahesh Ramanadham
exaly +2 more sources
Design of condition-based maintenance framework for process operations management in pharmaceutical continuous manufacturing. [PDF]
Int J Pharm, 2020 Continuous manufacturing, an emerging technology in the pharmaceutical industry, has the potential to increase the efficiency, and agility of pharmaceutical manufacturing processes.
Ganesh S +9 more
europepmc +2 more sources
Formulation Design of Amiodarone Hydrochloride Tablets Optimized for a Continuous Manufacturing Process [PDF]
PharmaceuticsBackground: Amiodarone hydrochloride is an antiarrhythmic agent, primarily classified as a Vaughan Williams Class III antiarrhythmic agent, used for the treatment and prevention of arrhythmia and designated as an essential national drug.
Ju-Hyun Yoon +3 more
doaj +2 more sources