scholarly journals Continuous Manufacturing of Recombinant Therapeutic Proteins: Upstream and Downstream Technologies

2017 ◽  
pp. 277-322 ◽  
Author(s):  
Rohan Patil ◽  
Jason Walther
Keyword(s):  
Therapeutic Proteins ◽  
Continuous Manufacturing

Recent Updates on Molecular Genetic Engineering Approaches and Applications of Human Therapeutic Proteins

2017 ◽  
Vol 18 (3) ◽  
pp. 217-232 ◽  
Author(s):  
Asim Azhar ◽  
Ejaj Ahmad ◽  
Qamar Zia ◽  
Mohammad Owais ◽  
Ghulam Md Ashraf
Keyword(s):  
Genetic Engineering ◽  
Molecular Genetic ◽  
Therapeutic Proteins

High‐capacity multimodal anion‐exchange membranes for polishing of therapeutic proteins

2021 ◽  
Author(s):  
Joshua Osuofa ◽  
Daniel Henn ◽  
Jinxiang Zhou ◽  
Anna Forsyth ◽  
Scott M. Husson
Keyword(s):  
Anion Exchange ◽  
Therapeutic Proteins ◽  
High Capacity ◽  
Anion Exchange Membranes

scholarly journals Continuous citrate‐capped gold nanoparticle synthesis in a two‐phase flow reactor

2021 ◽  
Author(s):  
Spyridon Damilos ◽  
Ioannis Alissandratos ◽  
Luca Panariello ◽  
Anand N. P. Radhakrishnan ◽  
Enhong Cao ◽  
...  
Keyword(s):  
Particle Size ◽  
Gold Nanoparticles ◽  
Residence Time ◽  
Flow Reactor ◽  
Phase Flow ◽  
Continuous Manufacturing ◽  
Two Phase ◽  
Process Yield ◽  
Au Nps ◽  
Manufacturing Platform

AbstractA continuous manufacturing platform was developed for the synthesis of aqueous colloidal 10–20 nm gold nanoparticles (Au NPs) in a flow reactor using chloroauric acid, sodium citrate and citric acid at 95 oC and 2.3 bar(a) pressure. The use of a two-phase flow system – using heptane as the continuous phase – prevented fouling on the reactor walls, while improving the residence time distribution. Continuous syntheses for up to 2 h demonstrated its potential application for continuous manufacturing, while live quality control was established using online UV-Vis photospectrometry that monitored the particle size and process yield. The synthesis was stable and reproducible over time for gold precursor concentration above 0.23 mM (after mixing), resulting in average particle size between 12 and 15 nm. A hydrophobic membrane separator provided successful separation of the aqueous and organic phases and collection of colloidal Au NPs in flow. Process yield increased at higher inlet flow rates (from 70 % to almost 100 %), due to lower residence time of the colloidal solution in the separator resulting in less fouling in the PTFE membrane. This study addresses the challenges for the translation of the synthesis from batch to flow and provides tools for the development of a continuous manufacturing platform for gold nanoparticles.Graphical abstract

scholarly journals Applications of Supercritical Anti-Solvent Process in Preparation of Solid Multicomponent Systems

Pharmaceutics ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 475
Author(s):  
Guijin Liu ◽  
Junjian Li ◽  
Shiming Deng
Keyword(s):  
Solid State ◽  
Solid Dispersions ◽  
Crystal Form ◽  
Great Promise ◽  
Computational Techniques ◽  
Large Contribution ◽  
Continuous Manufacturing ◽  
Multicomponent Systems ◽  
On Line ◽  
Underlying Mechanisms

Solid multicomponent systems (SMS) are gaining an increasingly important role in the pharmaceutical industry, to improve the physicochemical properties of active pharmaceutical ingredients (APIs). In recent years, various processes have been employed for SMS manufacturing. Control of the particle solid-state properties, such as size, morphology, and crystal form is required to optimize the SMS formulation. By utilizing the unique and tunable properties of supercritical fluids, supercritical anti-solvent (SAS) process holds great promise for the manipulation of the solid-state properties of APIs. The SAS techniques have been developed from batch to continuous mode. Their applications in SMS preparation are summarized in this review. Many pharmaceutical co-crystals and solid dispersions have been successfully produced via the SAS process, where the solid-state properties of APIs can be well designed by controlling the operating parameters. The underlying mechanisms on the manipulation of solid-state properties are discussed, with the help of on-line monitoring and computational techniques. With continuous researching, SAS process will give a large contribution to the scalable and continuous manufacturing of desired SMS in the near future.

scholarly journals PAT for Continuous Chromatography Integrated into Continuous Manufacturing of Biologics towards Autonomous Operation

Processes ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 472
Author(s):  
Florian Lukas Vetter ◽  
Steffen Zobel-Roos ◽  
Jochen Strube
Keyword(s):  
Molecular Weight ◽  
Zero Point ◽  
Test System ◽  
Target Component ◽  
Array Detector ◽  
Continuous Manufacturing ◽  
Fluorescence Detector ◽  
Autonomous Operation ◽  
Side Component ◽  
Process Disturbances

This study proposes a reliable inline PAT concept for the simultaneous monitoring of different product components after chromatography. The feed for purification consisted of four main components, IgG monomer, dimer, and two lower molecular weight components of 4.4 kDa and 1 kDa molecular weight. The proposed measurement setup consists of a UV–VIS diode-array detector and a fluorescence detector. Applying this system, a R2 of 0.93 for the target component, a R2 of 0.67 for the dimer, a R2 of 0.91 for the first side component and a R2 of 0.93 for the second side component is achieved. Root mean square error for IgG monomer was 0.027 g/L, for dimer 0.0047 g/L, for side component 1 0.016 g/L and for the side component 2 0.014 g/L. The proposed measurement concept tracked component concentration reliably down to 0.05 g/L. Zero-point fluctuations were kept within a standard deviation of 0.018 g/L for samples with no IgG concentration but with side components present, allowing a reliable detection of the target component. The main reason inline concentration measurements have not been established yet, is the false-positive measurement of target components when side components are present. This problem was eliminated using the combination of fluorescence and UV–VIS data for the test system. The use of this measurement system is simulated for the test system, allowing an automatic fraction cut at 0.05 g/L. In this simulation a consistent yield of >99% was achieved. Process disturbances for processed feed volume, feed purity and feed IgG concentration can be compensated with this setup. Compared to a timed process control, yield can be increased by up to 12.5%, if unexpected process disturbances occur.

Sign in / Sign up

Export Citation Format

Share Document