scholarly journals Impact of Freeze‐Thaw Processes on Monoclonal Antibody Platform Process Development

2021 ◽  
Author(s):  
Dennis Weber ◽  
Christian Sittig ◽  
Jürgen Hubbuch
Keyword(s):  
Monoclonal Antibody ◽  
Process Development ◽  
Freeze Thaw ◽  
Platform Process

Purification process development of a recombinant monoclonal antibody expressed in glycoengineered Pichia pastoris

2011 ◽  
Vol 76 (1) ◽  
pp. 7-14 ◽  
Author(s):  
Youwei Jiang ◽  
Fang Li ◽  
Dongxing Zha ◽  
Thomas I. Potgieter ◽  
Teresa Mitchell ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Pichia Pastoris ◽  
Process Development ◽  
Purification Process ◽  
Recombinant Monoclonal Antibody

Validation of highly specific and sensitive radioimmunoassays for lutropin, follitropin, and free alpha subunit in unextracted urine

1990 ◽  
Vol 36 (2) ◽  
pp. 340-344 ◽  
Author(s):  
H Landy ◽  
A L Schneyer ◽  
R W Whitcomb ◽  
W F Crowley
Keyword(s):  
Monoclonal Antibody ◽  
Urinary Excretion ◽  
Blood Volume ◽  
High Sensitivity ◽  
High Specificity ◽  
Urine Samples ◽  
Alpha Subunit ◽  
Glycoprotein Hormones ◽  
Urinary Ph ◽  
Freeze Thaw

Abstract Measurement of the urinary excretion of lutropin (LH) and follitropin (FSH) and their common free alpha subunit (FAS) assists in monitoring the maturation of the hypothalamic-pituitary-gonadal axis and in understanding the physiology of the pituitary glycoprotein hormones. Here we describe sensitive, specific polyclonal radioimmunoassays for LH and FSH and a monoclonal radioimmunoassay for FAS for use with urine--assays unperturbed by alterations in urinary pH or osmolarity within the broad physiological range encountered in urine. Concordance between LH, FSH, and FAS concentrations in extracted and unextracted urine samples was high. Linearity and parallelism with the standard curves was observed with addition of 25 to 200 microL of unextracted urine. No effect on glycoprotein concentration was seen after as many as 10 freeze-thaw cycles. The need for extraction was further obviated by the high sensitivity of each assay, reflected by minimum detectable doses well below the concentrations encountered in patients' samples. Thus we have measured gonadotropins in unextracted urine as precisely as in extracted urine. We also have demonstrated an equally versatile assay for urinary alpha subunit, using a monoclonal antibody of high specificity for this monomer in its free, uncombined form. These radioimmunoassays complement assays of gonadotropins and free alpha subunit in serum and will allow longitudinal investigations otherwise limited by the constraints of the patient's blood volume.

scholarly journals Recovery and purification process development for monoclonal antibody production

mAbs ◽  
2010 ◽  
Vol 2 (5) ◽  
pp. 480-499 ◽  
Author(s):  
Hui F. Liu ◽  
Junfen Ma ◽  
Charles Winter ◽  
Robert Bayer
Keyword(s):  
Monoclonal Antibody ◽  
Antibody Production ◽  
Process Development ◽  
Purification Process ◽  
Monoclonal Antibody Production

scholarly journals From gene to harvest: insights into upstream process development for the GMP production of a monoclonal antibody in transgenic tobacco plants

2015 ◽  
Vol 13 (8) ◽  
pp. 1094-1105 ◽  
Author(s):  
Markus Sack ◽  
Thomas Rademacher ◽  
Holger Spiegel ◽  
Alexander Boes ◽  
Stephan Hellwig ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Transgenic Tobacco ◽  
Process Development ◽  
Transgenic Tobacco Plants ◽  
Tobacco Plants ◽  
Upstream Process ◽  
Gmp Production

Robust factor selection in early cell culture process development for the production of a biosimilar monoclonal antibody

2016 ◽  
Vol 33 (1) ◽  
pp. 181-191 ◽  
Author(s):  
Michael Sokolov ◽  
Jonathan Ritscher ◽  
Nicola MacKinnon ◽  
Jean-Marc Bielser ◽  
David Brühlmann ◽  
...  
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Process Development ◽  
Cell Culture Process ◽  
Culture Process

Structural characterization of N-linked oligosaccharides on monoclonal antibody Nimotuzumab through process development

Biologicals ◽  
2012 ◽  
Vol 40 (4) ◽  
pp. 288-298 ◽  
Author(s):  
Raquel Montesino ◽  
Loany Calvo ◽  
Antonio Vallin ◽  
Pauline M. Rudd ◽  
David J. Harvey ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Structural Characterization ◽  
Process Development
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