The Use of Chromatography to Manufacture Purer and Safer Plasma Products

Clinical efficacy of highly purified, doubly virus‐inactivated factor VIII/von Willebrand factor concentrate (Fanhdi®) in the treatment of von Willebrand disease: a retrospective clinical study

“…Despite the fact that patients with vWD have been treated with plasma-derived FVIII/vWF concentrates for more than 20 years, only reports of small retrospective series are mainly available in the literature [18][19][20][21]. Therefore, a retrospective study such as this on the use of a FVIII/vWF concentrate in the treatment of vWD is still significant.…”

“…As far as clinical efficacy of these concentrates is concerned, there are the recently published results of a large prospective clinical trial [14] and those of a few retrospective studies [15][16][17][18]. Therefore, the main objective of this study was to evaluate in a retrospective series the clinical efficacy of a highly purified FVIII/vWF manufactured using a technology that allows the selective purification of the FVIII/ vWF complex [19] and the preservation of a high content of functional vWF [20][21][22]. Therefore, the main objective of this study was to evaluate in a retrospective series the clinical efficacy of a highly purified FVIII/vWF manufactured using a technology that allows the selective purification of the FVIII/ vWF complex [19] and the preservation of a high content of functional vWF [20][21][22].…”

Very Large Scale Monoclonal Antibody Purification: The Case for Conventional Unit Operations

“…Those that do (HSA and IgIV) typically employ the Cohn fractionation process and do not rely on chromatography for purification of these products. (There are some plasma-derived immunoglobulin products that have adopted chromatography, including a very large processing facility in Australia (5); however, the majority of IgIV processes are based on the Cohn process (6,7)). The Cohn process employs selective precipitation steps that manipulate pH, temperature, ethanol concentration, and ionic strength.…”

Pharmacokinetics and safety of Intragam 10 NF, the next generation 10% liquid intravenous immunoglobulin, in patients with primary antibody deficiencies

“…The production process for immunoglobulins has evolved dramatically over the years, including the advent of high‐concentration preparations, and the introduction of a minimum of two dedicated virus elimination steps to minimise the risk of pathogen transmission from plasma to patient 4 . Intragam P (6% liquid human IVIg stabilised with maltose) 5 was the first commercial IVIg produced solely by the use of chromatographic procedures, 6,7 a process that maximises IgG yield while preserving the purity and integrity of the IgG molecules 8 . Two dedicated and complementary virus reduction steps were included in the manufacturing process 5,8 …”

“…Intragam P (6% liquid human IVIg stabilised with maltose) 5 was the first commercial IVIg produced solely by the use of chromatographic procedures, 6,7 a process that maximises IgG yield while preserving the purity and integrity of the IgG molecules 8 . Two dedicated and complementary virus reduction steps were included in the manufacturing process 5,8 …”