scholarly journals Safety risk management for low molecular weight process‐related impurities in monoclonal antibody therapeutics: Categorization, risk assessment, testing strategy, and process development with leveraging clearance potential

2021 ◽  
Author(s):  
Haibin Luo ◽  
Yuling Li ◽  
David Robbins ◽  
Sheau‐Chiann Wang ◽  
Guoling Xi ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Molecular Weight ◽  
Monoclonal Antibody ◽  
Risk Management ◽  
Process Development ◽  
Low Molecular Weight ◽  
Testing Strategy ◽  
Safety Risk ◽  
Antibody Therapeutics ◽  
Related Impurities

scholarly journals Direct demonstration of an HLA-DR allotypic determinant on the low molecular weight (beta) subunit using a mouse monoclonal antibody specific for DR3

1982 ◽  
Vol 156 (1) ◽  
pp. 104-111 ◽  
Author(s):  
JP Johnson ◽  
T Meo ◽  
G Reithmuller ◽  
DJ Schendel ◽  
R Wank
Keyword(s):  
Molecular Weight ◽  
Monoclonal Antibody ◽  
Cell Surface ◽  
B Cell ◽  
Beta Subunit ◽  
Low Molecular Weight ◽  
Β Subunit ◽  
Direct Demonstration ◽  
Hla Dr ◽  
Human B Cell

A murine monoclonal antibody directed against a human B cell surface antigen with the characteristics of HLA-DR is described. The antigen detected is tightly linked to HLA and is correlated with the alloantigen HLA-Dw/DR3. Reactivity with a fraction of Dw/DRw6 cells is also observed. The determinant recognized by this antibody has been shown to be present on the smaller molecular weight β subunit of the HLA-DR antigen.

Patient safety risk assessment and risk management: A review on Indian hospitals

2011 ◽  
Vol 2 (4) ◽  
pp. 186 ◽  
Author(s):  
Gaurav Sharma ◽  
Anuj Dixit ◽  
Swapnil Awasthi ◽  
Garima Sharma
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Patient Safety ◽  
Safety Risk
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