Should charge variants of monoclonal antibody therapeutics be considered critical quality attributes?

2016 ◽  
Vol 37 (17-18) ◽  
pp. 2338-2346 ◽  
Author(s):  
Sumit Kumar Singh ◽  
Gunjan Narula ◽  
Anurag S. Rathore
Keyword(s):  
Monoclonal Antibody ◽  
Quality Attributes ◽  
Critical Quality Attributes ◽  
Antibody Therapeutics ◽  
Charge Variants

scholarly journals Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars

2021 ◽  
Vol 14 (3) ◽  
pp. 189
Author(s):  
Ali M. Alsamil ◽  
Thijs J. Giezen ◽  
Toine C. Egberts ◽  
Hubert G. Leufkens ◽  
Helga Gardarsdottir
Keyword(s):  
Quality Attributes ◽  
Regulatory Approval ◽  
Clinical Profile ◽  
Test Results ◽  
Critical Quality Attributes ◽  
Functional Attributes ◽  
European Public ◽  
Charge Variants ◽  
Assessment Reports

Regulatory approval of biosimilars predominantly relies on biosimilarity assessments of quality attributes (QAs), particularly the potentially critical QAs (pCQAs) that may affect the clinical profile. However, a limited understanding exists concerning how EU regulators reflect the biosimilarity assessments of (pC)QAs in European public assessment reports (EPARs) by different stakeholders. The type and extent of information on QAs and pCQAs in EPARs were evaluated for seven adalimumab biosimilars. Seventy-seven QAs, including 31 pCQAs, were classified and assessed for type (structural and functional attributes) and extent (biosimilarity interpretation and/or test results) of information in EPARs. Reporting on the QAs (35–75%) varied between EPARs, where the most emphasis was placed on pCQAs (65–87%). Functional attributes (54% QAs and 92% pCQAs) were reported more frequently than structural attributes (8% QAs and 22% pCQAs). About 50% (4 structural and 12 functional attributes) of pCQAs were consistently reported in all EPARs. Regulators often provided biosimilarity interpretation (QAs: 83% structural and 80% functional; pCQAs: 81% structural and 78% functional) but rarely include test results (QAs: 1% structural and 9% functional and pCQAs: 3% structural and 9% functional). Minor differences in structural attributes, commonly in glycoforms and charge variants, were often observed in adalimumab biosimilars but did not affect the functions and clinical profile. Despite the variability in reporting QAs in EPARs, the minor observed differences were largely quantitative and not essentially meaningful for the overall conclusion of biosimilarity of the seven adalimumab biosimilars.

scholarly journals Multi-attribute Raman spectroscopy (MARS) for monitoring product quality attributes in formulated monoclonal antibody therapeutics

mAbs ◽  
2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Bingchuan Wei ◽  
Nicholas Woon ◽  
Lu Dai ◽  
Raphael Fish ◽  
Michelle Tai ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Raman Spectroscopy ◽  
Product Quality ◽  
Quality Attributes ◽  
Antibody Therapeutics

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.

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