Biophysical and biochemical characterization of peptide and protein drug product

2012 ◽  
pp. 194-221
Author(s):  
Tapan Das ◽  
James Carroll
Keyword(s):  
Biochemical Characterization ◽  
Drug Product ◽  
Protein Drug

Biochemical Characterization of a Recombinant FIX Drug Candidate for Treatment of Hemophilia B

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4658-4658
Author(s):  
Peter Turecek ◽  
Susanne Vejda ◽  
Katalin Varadi ◽  
Hanspeter Rottensteiner ◽  
Ernst Boehm ◽  
...  
Keyword(s):  
Biochemical Characterization ◽  
Drug Product ◽  
Coagulation Factor ◽  
Factor Ix ◽  
Hemophilia B ◽  
Drug Candidate ◽  
Alternative Drug ◽  
Recombinant Factor Ix ◽  
Fermentation Technology

Abstract Abstract 4658 Human coagulation factor IX (FIX) is a vitamin-K-dependent coagulation factor whose absence or dysfunction causes hemophilia B. Treatment of hemophilia B is based on replacement therapy using highly purified FIX concentrates. Baxter has developed a recombinant factor IX for treating hemophilia B patients that is produced in a CHO cell-line using a serum and protein-free fermentation technology. The purification process avoids the use of immune-affinity chromatography and includes two viral reduction steps. The final drug product is formulated in the absence of proteins of animal or human origin. Baxter's recombinant FIX resembles commercially available rFIX in most characteristics with the exception of a significantly lower FIXa content, which might improve standardization compared to commercial rFIX products. Preclinical and clinical lots of rFIX were characterized with respect to their hemostatic potency, efficiency of activation by FXIa and FVIIa in the presence of tissue factor, and capacity to bind to phospholipid vesicles. Three lots of commercial rFIX with different potencies and one lot of a plasma-derived FIX product were included in the study. Similarity could be shown between the preclinical and clinical lots of rFIX in all these assays. Furthermore, the functional and biochemical characterization of Baxter's recombinant FIX showed that it resembles the recombinant comparator product. The phase I clinical trial which has been initiated will now have to show whether Baxter's rFIX can become an alternative drug candidate product for treating patients suffering from hemophilia B. Disclosures: Turecek: Baxter Innovations GmbH: Employment. Vejda:Baxter Innovations GmbH: Employment. Varadi:Baxter Innovations GmbH: Employment. Rottensteiner:Baxter Innovations GmbH: Employment. Boehm:Baxter Innovations GmbH: Employment. Reiter:Baxter Innovations GmbH: Employment. Kaliwoda:Baxter Innovations GmbH: Employment. Mundt:Baxter Innovations GmbH: Employment. Ehrlich:Baxter Innovations GmbH: Employment. Scheiflinger:Baxter Innovations GmbH: Employment.

Characterization of Polysorbate Ester Fractions and Implications in Protein Drug Product Stability

2020 ◽  
Vol 17 (7) ◽  
pp. 2345-2353 ◽  
Author(s):  
Anthony Tomlinson ◽  
Isidro E. Zarraga ◽  
Barthélemy Demeule
Keyword(s):  
Drug Product ◽  
Protein Drug

Plant Pathology Diagnosed by X-Ray Microanalysis

1987 ◽  
Vol 45 ◽  
pp. 974-975
Author(s):  
J. H. Resau ◽  
N. Howell ◽  
S. H. Chang
Keyword(s):  
Electron Microscopy ◽  
Plant Pathology ◽  
Biochemical Characterization ◽  
Nutrient Deficiency ◽  
Green Leaf ◽  
Parasitic Infestation ◽  
X Ray

Spinach grown in Texas developed “yellow spotting” on the peripheral portions of the leaves. The exact cause of the discoloration could not be determined as there was no evidence of viral or parasitic infestation of the plants and biochemical characterization of the plants did not indicate any significant differences between the yellow and green leaf portions of the spinach. The present study was undertaken using electron microscopy (EM) to determine if a micro-nutrient deficiency was the cause for the discoloration.Green leaf spinach was collected from the field and sent by express mail to the EM laboratory. The yellow and equivalent green portions of the leaves were isolated and dried in a Denton evaporator at 10-5 Torr for 24 hrs. The leaf specimens were then examined using a JEOL 100 CX analytical microscope. TEM specimens were prepared according to the methods of Trump et al.

Interaction effect of rootstocks on gas exchange parameters, biochemical changes and nutrientstatus in Sauvignon Blanc winegrapes

2014 ◽  
Vol 3 (3) ◽  
pp. 218-225
Author(s):  
R. G. Somkuwar ◽  
M. A. Bhange ◽  
A. K. Upadhyay ◽  
S. D. Ramteke
Keyword(s):  
Biochemical Characterization ◽  
Reducing Sugar ◽  
Wine Grape ◽  
Gas Exchange Parameters ◽  
Food Material ◽  
Total Carbohydrates ◽  
Salt Creek ◽  
Grape Varieties ◽  
Photosynthetic Activities

SauvignonBlanc wine grape was characterized for their various morphological, physiological and biochemical parameters grafted on different rootstocks. Significant differences were recorded for all the parameters studied. The studies on vegetative parameters revealed that the rootstock influences the vegetative growth thereby increasing the photosynthetic activities of a vine. The highest photosynthesis rate was recorded in 140-Ru grafted vine followed by Fercal whereas the lowest in Salt Creek rootstock grafted vines.The rootstock influenced the changes in biochemical constituents in the grafted vine thereby helping the plant to store enough food material. Significant differences were recorded for total carbohydrates, proteins, total phenols and reducing sugar. The vines grafted on1103-Pshowed highest carbohydrates and starch followed by 140-Ru,while the least amount of carbohydrates were recorded in 110-R and Salt Creek grafted vines respectively.Among the different rootstock graft combinations, Fercal showed highest amount of reducing sugar, proteins and phenols, followed by 1103-P and SO4, however, the lowest amount of reducing sugar, proteins and phenols were recorded with 110-R grafted vines.The vines grafted on different rootstocks showed changes in nutrient uptake. Considering this, the physico-biochemical characterization of grafted vine may help to identify particularrootstocks combination that could influence a desired trait in commercial wine grape varieties after grafting.

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