scholarly journals CMC and regulatory considerations for polyethylene glycol-modified protein therapeutics

2005 ◽  
Vol 20 (6) ◽  
pp. 620-634 ◽  
Author(s):  
Susan Cannon-Carlson ◽  
David Wylie ◽  
Doug Kline ◽  
Doug Inloes
Bioanalysis ◽  
2020 ◽  
Vol 12 (23) ◽  
pp. 1671-1679
Author(s):  
Yanqiu Liu ◽  
Nancy Yu ◽  
Mehraban Khosraviani ◽  
Eric Wakshull

Background: PEGylation technology is one of long-acting delivery (LAD) platforms used to increase half-life of protein therapeutics. However, PEGylation of anti-Factor D Fab (PEG-aFD) poses challenges for detecting anti-drug antibody (ADA) to both Fab and polyethylene glycol (PEG) portions. Results: Although the bridging ELISA using traditional assay diluent containing Tween 20 is good for detecting ADA to Fab, it failed to detect ADA to PEG. Instead of only reducing Tween 20 in assay diluent, using a proprietary commercial buffer PEG50-1 as assay diluent successfully enabled the detection of ADA to both Fab and PEG with fit-for-purpose sensitivity and drug tolerance. Conclusion: Identification of appropriate assay diluent is critical for detection of ADA to both Fab and PEG in a PEGylated molecule.


Author(s):  
Kuixiong Gao ◽  
Randal E. Morris ◽  
Bruce F. Giffin ◽  
Robert R. Cardell

Several enzymes are involved in the regulation of anabolic and catabolic pathways of carbohydrate metabolism in liver parenchymal cells. The lobular distribution of glycogen synthase (GS), phosphoenolpyruvate carboxykinase (PEPCK) and glycogen phosphorylase (GP) was studied by immunocytochemistry using cryosections of normal fed and fasted rat liver. Since sections of tissue embedded in polyethylene glycol (PEG) show good morphological preservation and increased detectability for immunocytochemical localization of antigenic sites, and semithin sections of Visio-Bond (VB) embedded tissue provide higher resolution of cellular structure, we applied these techniques and immunogold-silver stain (IGSS) for a more accurate localization of hepatic carbohydrate metabolic enzymes.


Author(s):  
Dai Dalin ◽  
Guo Jianmin

Lipid cytochemistry has not yet advanced far at the EM level. A major problem has been the loss of lipid during dehydration and embedding. Although the adoption of glutaraldehyde and osmium tetroxide accelerate the chemical reaction of lipid and osmium tetroxide can react on the double bouds of unsaturated lipid to from the osmium black, osmium tetroxide can be reduced in saturated lipid and subsequently some of unsaturated lipid are lost during dehydration. In order to reduce the loss of lipid by traditional method, some researchers adopted a few new methods, such as the change of embedding procedure and the adoption of new embedding media, to solve the problem. In a sense, these new methods are effective. They, however, usually require a long period of preparation. In this paper, we do research on the fiora nectary strucure of lauraceae by the rapid-embedding method wwith PEG under electron microscope and attempt to find a better method to solve the problem mentioned above.


2008 ◽  
Vol 42 (2) ◽  
pp. 48
Author(s):  
DOUG BRUNK

1992 ◽  
Vol 85 (2) ◽  
pp. 345-351 ◽  
Author(s):  
Gokarna B. Gharti-Chhetri ◽  
Wichai Cherdshewasart ◽  
Jocelyne Dewulf ◽  
Michel Jacobs ◽  
loan Negrutiu

2018 ◽  
Author(s):  
A Elmekkaoui ◽  
M Oualgouh ◽  
A Zazour ◽  
W Khannoussi ◽  
G Kharrasse ◽  
...  

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