Effect of Formulation and Process Variables on the Critical Quality Attributes of Warfarin Sodium Tablets

2016 ◽  
Author(s):  
Akhtar Siddiqui
Keyword(s):  
Quality Attributes ◽  
Process Variables ◽  
Critical Quality Attributes ◽  
Warfarin Sodium

Understanding effect of formulation and manufacturing variables on the critical quality attributes of warfarin sodium product

2015 ◽  
Vol 495 (1) ◽  
pp. 19-30 ◽  
Author(s):  
Ziyaur Rahman ◽  
Maxwell Korang-Yeboah ◽  
Akhtar Siddiqui ◽  
Adil Mohammad ◽  
Mansoor A. Khan
Keyword(s):  
Quality Attributes ◽  
Critical Quality Attributes ◽  
Warfarin Sodium

Energieverbrauchssimulation von Werkzeugmaschinen*/Process-specific energetic simulation of machine tools

2016 ◽  
Vol 106 (01-02) ◽  
pp. 60-64
Author(s):  
S. Braun ◽  
P. Schraml ◽  
E. Abele
Keyword(s):  
Energy Consumption ◽  
Machine Tools ◽  
Value Added ◽  
Quality Attributes ◽  
Resource Efficiency ◽  
Prediction System ◽  
Critical Quality Attributes ◽  
Milling Operations ◽  
Nc Program ◽  
Modern Machine

Energie- und Ressourceneffizienz sind Qualitätsmerkmale, die auch für moderne Werkzeugmaschinen gelten. Der Energieverbrauch von Maschinen bis zu gesamten Fertigungsstandorten muss im Verhältnis zur erzielten Wertschöpfung deutlich gesenkt werden, um wettbewerbsfähig zu bleiben und unserer Verantwortung gegenüber der Umwelt zu entsprechen. Dieser Beitrag präsentiert anhand eines Fräsprozesses ein modellgestütztes Simulations- und Prognosesystem des Energieverbrauchs von kompletten Bearbeitungsoperationen auf einer Werkzeugmaschine als Basis energetischer Optimierungen.   Resource efficiency and energy consumption are critical quality attributes of modern machine tools. The energy consumption of machine tools, plants and facilities must be significantly reduced relative to the value added in order to stay competitive and fulfil our responsibility towards the environment. This article presents a model-based simulation and prediction system of the expected energy consumption of machine tools executing a given process NC-program as a basis for energetic optimization measures. It is exemplified by milling operations.

Determination of critical quality attributes for monoclonal antibodies using quality by design principles

Biologicals ◽  
2016 ◽  
Vol 44 (5) ◽  
pp. 291-305 ◽  
Author(s):  
Nadja Alt ◽  
Taylor Y. Zhang ◽  
Paul Motchnik ◽  
Ron Taticek ◽  
Valerie Quarmby ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Quality By Design ◽  
Design Principles ◽  
Quality Attributes ◽  
Critical Quality Attributes

scholarly journals New Opportunities in Glycan Engineering for Therapeutic Proteins

Antibodies ◽  
2022 ◽  
Vol 11 (1) ◽  
pp. 5
Author(s):  
Xiaotian Zhong ◽  
Aaron M. D’Antona ◽  
John J. Scarcelli ◽  
Jason C. Rouse
Keyword(s):  
Fusion Proteins ◽  
Therapeutic Proteins ◽  
Quality Attributes ◽  
Efficacy And Safety ◽  
Biological Functions ◽  
Next Generation ◽  
Lysosomal Degradation ◽  
Critical Quality Attributes ◽  
Recombinant Fusion Proteins ◽  
Antibody Diversification

Glycans as sugar polymers are important metabolic, structural, and physiological regulators for cellular and biological functions. They are often classified as critical quality attributes to antibodies and recombinant fusion proteins, given their impacts on the efficacy and safety of biologics drugs. Recent reports on the conjugates of N-acetyl-galactosamine and mannose-6-phosphate for lysosomal degradation, Fab glycans for antibody diversification, as well as sialylation therapeutic modulations and O-linked applications, have been fueling the continued interest in glycoengineering. The current advancements of the human glycome and the development of a comprehensive network in glycosylation pathways have presented new opportunities in designing next-generation therapeutic proteins.

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