PURIFICATION OF IVIg (INTRAVENOUS IMMUNOGLOBULIN) FROM IGNG MANUFACTURING PROCESS TO OPTIMIZE PRODUCT TOLERABILITY PROFILE: EXAMPLE OF HUMAN NORMAL IMMUNOGLOBULIN (Iqymune® 100 mg/mL, SOLUTION FOR INFUSION)

2016 ◽  
Author(s):  
Rabye Ouaja
Keyword(s):  
Intravenous Immunoglobulin ◽  
Manufacturing Process ◽  
Tolerability Profile

Effects of the manufacturing process on the anti-A isoagglutinin titers in intravenous immunoglobulin products

Transfusion ◽  
2015 ◽  
Vol 55 (S2) ◽  
pp. S105-S109 ◽  
Author(s):  
Val Romberg ◽  
Liane Hoefferer ◽  
Ibrahim El Menyawi
Keyword(s):  
Intravenous Immunoglobulin ◽  
Manufacturing Process

Capacity of the manufacturing process of Flebogamma® DIF, a new human high purity intravenous immunoglobulin, to remove a TSE model-agent

Biologicals ◽  
2010 ◽  
Vol 38 (6) ◽  
pp. 670-674 ◽  
Author(s):  
José M. Diez ◽  
Santiago Caballero ◽  
Francisco Belda ◽  
Magdalena Otegui ◽  
Rodrigo Gajardo ◽  
...  
Keyword(s):  
Intravenous Immunoglobulin ◽  
High Purity ◽  
Manufacturing Process

scholarly journals Lessons Learned in Protein Precipitation Using a Membrane Emulsification Technique to Produce Reversible and Uniform Microbeads

Pharmaceutics ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 1738
Author(s):  
Sang-Koo Park ◽  
Ga Yeon Noh ◽  
Hyun Woo Yu ◽  
Eun Chae Lee ◽  
Junoh Jeong ◽  
...  
Keyword(s):  
Intravenous Immunoglobulin ◽  
Porous Glass ◽  
Manufacturing Process ◽  
Protein Concentration ◽  
Lessons Learned ◽  
The Other ◽  
Silicone Resin ◽  
Hydrophobic Modification ◽  
Hydrophobically Modified ◽  
Model Protein

The effects of the manufacturing process and the regeneration of Shirasu porous glass (SPG) membranes were investigated on the reproducibility of protein precipitants, termed protein microbeads. Intravenous immunoglobulin (IVIG) was selected as a model protein to produce its microbeads in seven different cases. The results showed that the hydrophobically modified SPG membrane produced finer microbeads than the hydrophilic SPG membrane, but this was inconsistent when using the general regeneration method. Its reproducibility was determined to be mostly dependent on rinsing the SPG membrane prior to the modification and on the protein concentration used for emulsification. The higher concentration could foul and plug the membrane during protein release and thus the membrane must be washed thoroughly before hydrophobic modification. Moreover, the membrane regenerated by silicone resin dissolved in ethanol had better reproducibility than silicone resin dissolved in water. On the other hand, rinsing the protein precipitant with cold ethanol after the emulsification was not favorable and induced protein aggregation. With the addition of trehalose, the purity of the IVIG microbeads was almost the same as before microbeadification. Therefore, the regeneration method, protein concentration, and its stabilizer are key to the success of protein emulsification and precipitation using the SPG membrane.

scholarly journals A new manufacturing process to remove thrombogenic factors (II, VII, IX, X, and XI) from intravenous immunoglobulin gamma preparations

Biologicals ◽  
2017 ◽  
Vol 45 ◽  
pp. 1-8 ◽  
Author(s):  
Dong Hwarn Park ◽  
Gil Bu Kang ◽  
Dae Eun Kang ◽  
Jeung Woon Hong ◽  
Min Gyu Lee ◽  
...  
Keyword(s):  
Intravenous Immunoglobulin ◽  
Manufacturing Process ◽  
Immunoglobulin Gamma

Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process

Vox Sanguinis ◽  
2003 ◽  
Vol 84 (3) ◽  
pp. 176-187 ◽  
Author(s):  
S. R. Trejo ◽  
J. A. Hotta ◽  
W. Lebing ◽  
C. Stenland ◽  
R. E. Storms ◽  
...  
Keyword(s):  
Intravenous Immunoglobulin ◽  
Manufacturing Process

Identifying groups of airborne particles by ordination

1994 ◽  
Vol 52 ◽  
pp. 856-857
Author(s):  
M. Shlepr ◽  
C. M. Vicroy
Keyword(s):  
Elemental Analysis ◽  
Energy Dispersive Spectroscopy ◽  
Manufacturing Process ◽  
Spatial Representation ◽  
Airborne Particles ◽  
Common Source ◽  
Data Set ◽  
Microelectronics Industry ◽  
Induced Changes ◽  
Source Materials

The microelectronics industry is heavily tasked with minimizing contaminates at all steps of the manufacturing process. Particles are generated by physical and/or chemical fragmentation from a mothersource. The tools and macrovolumes of chemicals used for processing, the environment surrounding the process, and the circuits themselves are all potential particle sources. A first step in eliminating these contaminants is to identify their source. Elemental analysis of the particles often proves useful toward this goal, and energy dispersive spectroscopy (EDS) is a commonly used technique. However, the large variety of source materials and process induced changes in the particles often make it difficult to discern if the particles are from a common source.Ordination is commonly used in ecology to understand community relationships. This technique usespair-wise measures of similarity. Separation of the data set is based on discrimination functions. Theend product is a spatial representation of the data with the distance between points equaling the degree of dissimilarity.

Water in the Vinegar Manufacturing Process

1952 ◽  
Vol 44 (3) ◽  
pp. 449-449
Author(s):  
Rudolph Allgeier ◽  
Reuben Wisthoff ◽  
Frank Hildebrandt
Keyword(s):  
Manufacturing Process
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