Transfer of continuous manufacturing process principles for mAb production in a GMP environment - a step in the transition from batch to continuous.
Sign Up to like & getrecommendations! Published in 2022 at "Biotechnology progress"
DOI: 10.1002/btpr.3259
Abstract: Implementation of continuous in lieu of batch upstream processing (USP) and downstream process (DSP) for the production of recombinant therapeutic protein is a significant paradigm change. The present report describes how the first kilograms of… read more here.
Keywords: process; production; batch; continuous manufacturing ... See more keywords
An innovative strategy to recycle permeate in biologics continuous manufacturing process to improve material efficiency and sustainability.
Sign Up to like & getrecommendations! Published in 2022 at "Biotechnology progress"
DOI: 10.1002/btpr.3262
Abstract: Intensified perfusion processes are an integral part of continuous manufacturing for biopharmaceuticals which enable agile operations and significant reduction in cost of goods. However, they require large volumes of media to support robust cell growth… read more here.
Keywords: perfusion; material efficiency; process; improve material ... See more keywords
Upstream process intensification and continuous manufacturing
Sign Up to like & getrecommendations! Published in 2018 at "Current Opinion in Chemical Engineering"
DOI: 10.1016/j.coche.2018.10.006
Abstract: Manufacturing process of biopharmaceuticals usually starts from culturing recombinant protein producing cells, predominately Chinese Hamster Ovary (CHO) cells, in bioreactors. Currently, fed-batch cell culture process is the most common upstream process method due to its… read more here.
Keywords: process intensification; cell culture; upstream process; process ... See more keywords
Design of Condition-based Maintenance Framework for Process Operations Management in Pharmaceutical Continuous Manufacturing.
Sign Up to like & getrecommendations! Published in 2020 at "International journal of pharmaceutics"
DOI: 10.1016/j.ijpharm.2020.119621
Abstract: Continuous manufacturing, an emerging technology in the pharmaceutical industry, has the potential to increase the efficiency, and agility of pharmaceutical manufacturing processes. To realize these potential benefits of continuous operations, effectively managing materials, equipment, analyzers,… read more here.
Keywords: based maintenance; management; process; condition based ... See more keywords
Development of a continuous manufacturing process for self-reinforced composites using multi-step highly drawn polypropylene tapes
Sign Up to like & getrecommendations! Published in 2020 at "Polymer"
DOI: 10.1016/j.polymer.2020.122267
Abstract: Abstract Despite the benefits of recycling, impact resistance, and lightweightness, polypropylene (PP) self-reinforced composites (SRCs) still suffer from a lack of research, especially in continuous manufacturing processes. Herein we report a comprehensive study, from the… read more here.
Keywords: self reinforced; polypropylene; reinforced composites; highly drawn ... See more keywords
Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2017.06.015
Abstract: Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which… read more here.
Keywords: manufacturing pharmaceuticals; manufacturing; international symposium; continuous manufacturing ... See more keywords
Characterization of Near-Infrared and Raman Spectroscopy for In-Line Monitoring of a Low-Drug Load Formulation in a Continuous Manufacturing Process.
Sign Up to like & getrecommendations! Published in 2019 at "Analytical chemistry"
DOI: 10.1021/acs.analchem.8b05002
Abstract: Reflectance spectroscopy is an excellent candidate for process analytical technology (PAT) applications in continuous manufacturing of pharmaceutical tablets. Spectroscopic methods provide a real-time, nondestructive measurement of the active pharmaceutical ingredient (API) concentration in order to… read more here.
Keywords: low drug; process; spectroscopy; raman spectroscopy ... See more keywords
Biocatalytic Continuous Manufacturing of Diabetes Drug: Plantwide Process Modeling, Optimization, and Environmental and Economic Analysis
Sign Up to like & getrecommendations! Published in 2018 at "ACS Sustainable Chemistry & Engineering"
DOI: 10.1021/acssuschemeng.8b04673
Abstract: This work proposes a comprehensive framework of biocatalytic continuous manufacturing of sitagliptin, the active pharmaceutical ingredient of the leading dipeptidyl peptidase-4 inhibitor antidiabetic drug. Continuous manufacturing has the advantages of quality consistency, reduced waste generation,… read more here.
Keywords: economic analysis; drug; process; manufacturing ... See more keywords
Drying behavior of a horizontal vibrated fluidized bed dryer for continuous manufacturing
Sign Up to like & getrecommendations! Published in 2023 at "Pharmaceutical Development and Technology"
DOI: 10.1080/10837450.2023.2205932
Abstract: Abstract Twin-screw wet granulation offers the possibility to granulate continuously. A drying step after wet granulation is required to realize a full continuous manufacturing line. Aim of this study was to gain insights into the… read more here.
Keywords: continuous manufacturing; bed dryer; drying behavior; temperature ... See more keywords
Continuous Manufacturing and Molecular Modeling of Pharmaceutical Amorphous Solid Dispersions
Sign Up to like & getrecommendations! Published in 2022 at "AAPS PharmSciTech"
DOI: 10.1208/s12249-022-02408-4
Abstract: Amorphous solid dispersions enhance solubility and oral bioavailability of poorly water-soluble drugs. The escalating number of drugs with poor aqueous solubility, poor dissolution, and poor oral bioavailability is an unresolved problem that requires adequate interventions.… read more here.
Keywords: solid dispersions; continuous manufacturing; amorphous solid; molecular modeling ... See more keywords
Direct Tableting on a Continuous Manufacturing Line—Impact of Mixing Parameters, Material Densities, and Drug Load on Subsequent Process Parameters and Tablet Quality
Sign Up to like & getrecommendations! Published in 2023 at "AAPS PharmSciTech"
DOI: 10.1208/s12249-023-02525-8
Abstract: The continuous manufacturing (CM) of solid oral dosage forms has received increased attention in recent years and has become a leading technology in the pharmaceutical industry. A model has been developed based on process data… read more here.
Keywords: continuous manufacturing; process parameters; process; bulk density ... See more keywords