scholarly journals Semi-automation of process analytics reduces operator effect

2019 ◽  
Vol 43 (5) ◽  
pp. 753-764 ◽  
Author(s):  
A. Christler ◽  
E. Felföldi ◽  
M. Mosor ◽  
D. Sauer ◽  
N. Walch ◽  
...  
Keyword(s):  
Host Cell ◽  
Process Analytical Technology ◽  
Work Load ◽  
Downstream Processing ◽  
Test Results ◽  
Process Analytics ◽  
Host Cell Proteins ◽  
Relative Standard ◽  
Elution Peak ◽  
Analytical Technology

AbstractThe aim of this study was to semi-automate process analytics for the quantification of common impurities in downstream processing such as host cell DNA, host cell proteins and endotoxins using a commercial liquid handling station. By semi-automation, the work load to fully analyze the elution peak of a purification run was reduced by at least 2.41 h. The relative standard deviation of results among different operators over a time span of up to 6 months was at the best reduced by half, e.g. from 13.7 to 7.1% in dsDNA analysis. Automation did not improve the reproducibility of results produced by one operator but released time for data evaluation and interpretation or planning of experiments. Overall, semi-automation of process analytics reduced operator-specific influence on test results. Such robust and reproducible analytics is fundamental to establish process analytical technology and get downstream processing ready for Quality by Design approaches.

Reduction of Setup Time through SMED Approach

2015 ◽  
Vol 2 (2) ◽  
pp. 20-32 ◽  
Author(s):  
Prabir Kumar Bandyopadhyay ◽  
Sandeep Naik ◽  
Kunal K. Ganguly
Keyword(s):  
Process Improvement ◽  
Process Analytical Technology ◽  
Work Load ◽  
Setup Time ◽  
Pharmaceutical Manufacturing ◽  
Activity Time ◽  
Productivity Improvement ◽  
Manufacturing Firm ◽  
Analytical Technology

This paper discusses various issues involved with process improvement in pharmaceutical manufacturing firms which creates impediment in introducing change in manufacturing process and refers to the initiatives taken by PAT (Process Analytical Technology) Framework, which encourages pharma companies to introduce change in manufacturing processes for productivity improvement. Setup time contributes a substantial amount of reduction in machine availability in pharma companies. Through a case study of a pharma manufacturing firm the paper explains how SMED can be implemented resulting substantial saving of down time without increasing the work load of the operators. It shows how the activities involved in machine setup can be divided in two classes—internal and external—and how ECRS (Eliminate, Combine, Rearrange and simplify) principles can be applied to reduce the activity time.

scholarly journals Digital Twin for Lyophilization by Process Modeling in Manufacturing of Biologics

Processes ◽  
2020 ◽  
Vol 8 (10) ◽  
pp. 1325
Author(s):  
Leon S. Klepzig ◽  
Alex Juckers ◽  
Petra Knerr ◽  
Frank Harms ◽  
Jochen Strube
Keyword(s):  
Process Design ◽  
Process Model ◽  
Process Analytical Technology ◽  
Downstream Processing ◽  
Pilot Scale ◽  
Digital Twin ◽  
Physical Chemical ◽  
Optimization And Control ◽  
And Control ◽  
Analytical Technology

Lyophilization stabilizes formulated biologics for storage, transport and application to patients. In process design and operation it is the link between downstream processing and with final formulation to fill and finish. Recent activities in Quality by Design (QbD) have resulted in approaches by regulatory authorities and the need to include Process Analytical Technology (PAT) tools. An approach is outlined to validate a predictive physical-chemical (rigorous) lyophilization process model to act quantitatively as a digital twin in order to allow accelerated process design by modeling and to further-on develop autonomous process optimization and control towards real time release testing. Antibody manufacturing is chosen as a typical example for actual biologics needs. Literature is reviewed and the presented procedure is exemplified to quantitatively and consistently validate the physical-chemical process model with aid of an experimental statistical DOE (design of experiments) in pilot scale.

scholarly journals Precision analysis for the determination of steric mass action parameters using eight tobacco host cell proteins

2021 ◽  
pp. 462379
Author(s):  
C.R. Bernau ◽  
R.C. Jäpel ◽  
J.W. Hübbers ◽  
S. Nölting ◽  
P. Opdensteinen ◽  
...  
Keyword(s):  
Host Cell ◽  
Mass Action ◽  
Precision Analysis ◽  
Host Cell Proteins

scholarly journals Exploiting Fluorescent Reporter Molecules for Process Analytical Technology (PAT)

2009 ◽  
Vol 63 (3) ◽  
pp. 171-173 ◽  
Author(s):  
Tobias Broger ◽  
Res P. Odermatt ◽  
Pablo Ledergerber ◽  
Bernhard Sonnleitner
Keyword(s):  
Process Analytical Technology ◽  
Fluorescent Reporter ◽  
Analytical Technology

Process analytical technology for bakery industry: A review

2019 ◽  
Vol 42 (5) ◽  
Author(s):  
Rifna E. Jerome ◽  
Sushil K. Singh ◽  
Madhuresh Dwivedi
Keyword(s):  
Process Analytical Technology ◽  
Bakery Industry ◽  
Analytical Technology
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