Determination of Critical Quality Attributes for a Biotherapeutic in the QbD Paradigm: GCSF as a Case Study

2017 ◽  
Vol 19 (6) ◽  
pp. 1826-1841 ◽  
Author(s):  
Sumit K. Singh ◽  
Deepak Kumar ◽  
Anurag S. Rathore
Biologicals ◽  
2016 ◽  
Vol 44 (5) ◽  
pp. 291-305 ◽  
Author(s):  
Nadja Alt ◽  
Taylor Y. Zhang ◽  
Paul Motchnik ◽  
Ron Taticek ◽  
Valerie Quarmby ◽  
...  

2015 ◽  
Vol 80 (7) ◽  
pp. S1574-S1582 ◽  
Author(s):  
Wisdom Wardy ◽  
Amporn Sae-Eaw ◽  
Sujinda Sriwattana ◽  
Hong Kyoon No ◽  
Witoon Prinyawiwatkul

2017 ◽  
Vol 43 (6) ◽  
pp. 911-916 ◽  
Author(s):  
Michał Teżyk ◽  
Emilia Jakubowska ◽  
Kasylda Milczewska ◽  
Bartłomiej Milanowski ◽  
Adam Voelkel ◽  
...  

TAPPI Journal ◽  
2012 ◽  
Vol 11 (10) ◽  
pp. 9-17
Author(s):  
ALESSANDRA GERLI ◽  
LEENDERT C. EIGENBROOD

A novel method was developed for the determination of linting propensity of paper based on printing with an IGT printability tester and image analysis of the printed strips. On average, the total fraction of the surface removed as lint during printing is 0.01%-0.1%. This value is lower than those reported in most laboratory printing tests, and more representative of commercial offset printing applications. Newsprint paper produced on a roll/blade former machine was evaluated for linting propensity using the novel method and also printed on a commercial coldset offset press. Laboratory and commercial printing results matched well, showing that linting was higher for the bottom side of paper than for the top side, and that linting could be reduced on both sides by application of a dry-strength additive. In a second case study, varying wet-end conditions were used on a hybrid former machine to produce four paper reels, with the goal of matching the low linting propensity of the paper produced on a machine with gap former configuration. We found that the retention program, by improving fiber fines retention, substantially reduced the linting propensity of the paper produced on the hybrid former machine. The papers were also printed on a commercial coldset offset press. An excellent correlation was found between the total lint area removed from the bottom side of the paper samples during laboratory printing and lint collected on halftone areas of the first upper printing unit after 45000 copies. Finally, the method was applied to determine the linting propensity of highly filled supercalendered paper produced on a hybrid former machine. In this case, the linting propensity of the bottom side of paper correlated with its ash content.


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