Application of a Quality by Design Approach to the Cell Culture Process of Monoclonal Antibody Production, Resulting in the Establishment of a Design Space

2013 ◽  
Vol 102 (12) ◽  
pp. 4274-4283 ◽  
Author(s):  
Hiroaki Nagashima ◽  
Akiko Watari ◽  
Yasuharu Shinoda ◽  
Hiroshi Okamoto ◽  
Shinya Takuma
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Antibody Production ◽  
Quality By Design ◽  
Design Space ◽  
Design Approach ◽  
Cell Culture Process ◽  
Monoclonal Antibody Production ◽  
Culture Process ◽  
Quality By Design Approach

Characterization of a Monoclonal Antibody Cell Culture Production Process Using a Quality by Design Approach

2010 ◽  
Vol 45 (3) ◽  
pp. 203-206 ◽  
Author(s):  
Brian Horvath ◽  
Melissa Mun ◽  
Michael W. Laird
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Production Process ◽  
Quality By Design ◽  
Design Approach ◽  
Culture Production ◽  
Quality By Design Approach

scholarly journals The way to a design space for an animal cell culture process according to Quality by Design (QbD)

2011 ◽  
Vol 5 (S8) ◽  
Author(s):  
Robert Puskeiler ◽  
Jan Kreuzmann ◽  
Caroline Schuster ◽  
Katharina Didzus ◽  
Nicole Bartsch ◽  
...  
Keyword(s):  
Cell Culture ◽  
Quality By Design ◽  
Design Space ◽  
Animal Cell ◽  
Animal Cell Culture ◽  
Cell Culture Process ◽  
Culture Process ◽  
The Way

APPLICATION OF AMBR15 MINIBIOREACTORS IN CHARACTERIZATION OF SUSPENSION MONOCLONAL ANTIBODY CHO-PRODUCER CELL CULTURE PROCESS BASED ON QBD PRINCIPLES

2021 ◽  
Vol 1 (19) ◽  
pp. 180-181
Author(s):  
A.N. Morozov ◽  
I.R. Yakhin
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Quality By Design ◽  
Systematic Approach ◽  
Cell Culture Process ◽  
Culture Process ◽  
Producer Cell

A systematic approach to characterizing the cell culture process of CHO-producers of monoclonal antibodies within the framework of the concept "Quality by design" (QbD) with the use of ambr15 mini-bioreactors (TAP Biosystems) is shown.

Applying the Quality by Design to Robust Optimization and Design Space Define for Erythropoietin Cell Culture Process

2019 ◽  
Vol 40 (10) ◽  
pp. 1002-1012 ◽  
Author(s):  
Tae Kyu Kim ◽  
Kwang‐Seok Seo ◽  
Sang‐Oh Kwon ◽  
Hee‐Sung Kim ◽  
Jun‐Hee Kim ◽  
...  
Keyword(s):  
Cell Culture ◽  
Robust Optimization ◽  
Quality By Design ◽  
Design Space ◽  
Cell Culture Process ◽  
Culture Process

Fermentanomics: Relating quality attributes of a monoclonal antibody to cell culture process variables and raw materials using multivariate data analysis

2015 ◽  
Vol 31 (6) ◽  
pp. 1586-1599 ◽  
Author(s):  
Anurag S. Rathore ◽  
Sumit Kumar Singh ◽  
Mili Pathak ◽  
Erik K. Read ◽  
Kurt A. Brorson ◽  
...  
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Data Analysis ◽  
Multivariate Data Analysis ◽  
Raw Materials ◽  
Multivariate Data ◽  
Quality Attributes ◽  
Cell Culture Process ◽  
Process Variables ◽  
Culture Process

Kinetic modeling as a tool to understand the influence of cell culture process parameters on the glycation of monoclonal antibody biotherapeutics

2019 ◽  
Vol 35 (5) ◽  
Author(s):  
Nitin Agarwal ◽  
Alison Mason ◽  
Rahul Pradhan ◽  
Jan Kemper ◽  
Allen Bosley ◽  
...  
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Kinetic Modeling ◽  
Process Parameters ◽  
Cell Culture Process ◽  
Culture Process

scholarly journals Cell culture processes for monoclonal antibody production

mAbs ◽  
2010 ◽  
Vol 2 (5) ◽  
pp. 466-479 ◽  
Author(s):  
Feng Li ◽  
Natarajan Vijayasankaran ◽  
Amy (Yijuan) Shen ◽  
Robert Kiss ◽  
Ashraf Amanullah
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Antibody Production ◽  
Monoclonal Antibody Production

scholarly journals Quality by Design approach in the development of a magnetic transducer for biomedical measurements: preliminary results on Design Space configuration

2016 ◽  
Vol 772 ◽  
pp. 012016 ◽  
Author(s):  
D R Louzada ◽  
E C Monteiro ◽  
A M Rivero ◽  
L G S Fortaleza ◽  
C R H Barbosa ◽  
...  
Keyword(s):  
Quality By Design ◽  
Design Space ◽  
Design Approach ◽  
Preliminary Results ◽  
Magnetic Transducer ◽  
Quality By Design Approach ◽  
Biomedical Measurements
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