Removal of Coagulation Factors by the Gamunex®-C Purification Process

Williams, Melanie; Willey, Jeff; Tull, Katherine; Stevenson, Glenn W.; Parks, Mona; McElrath, LaToya; Golovko, Luda; Russ, Catherine; Griffin, John; Vandeberg, Pete

doi:10.1016/j.jaci.2012.12.712

Cited by 5 publications

(8 citation statements)

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“…The caprylate/chromatography process described for TIG-C was based on the established methods for manufacturing 20% IGSC (Xembify®, Grifols, Clayton, NC, USA) and 10% IGIV (Gamunex-C®, Grifols). [19,20] In addition, this process is being utilized for the production of concentrated immune globulins for other diseases, e.g., COVID-19 [22], rabies [24], and Ebola. [23] Based on the clinical trial data generated during the development of these products and the post-marketing surveillance, the caprylate/chromatography process yield safe and effective immune globulin products.…”

Section: Discussionmentioning

confidence: 99%

“…In addition to the removal/inactivation of potential blood-borne pathogens, the caprylate/chromatography process is effective at removing coagulation factor impurities from the final product [ 20 ]. The Factor XI content was reduced to below detection level in the final product.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…[16,17] The product described in this paper (TIG-caprylate/chromatography process: TIG-C) was manufactured using a new manufacturing process which involves treatment with caprylate and purification by chromatography. [18][19][20] While the safety profile of TIG manufactured using the previous solvent detergent purification process is excellent, some procoagulant factors were retained in the https://doi.org/10.1017/S095026882200142X Published online by Cambridge University Press products. [21] The new caprylate/ chromatography was developed to reduce the procoagulant activity in the resulting TIG-C product.…”

Section: Introductionmentioning

confidence: 99%

“…The product described in this paper (TIG-caprylate/chromatography process: TIG-C) was manufactured using a new manufacturing process which involves treatment with caprylate and purification by chromatography [18][19][20]. While the safety profile of TIG manufactured using the previous solvent detergent purification process is excellent, some procoagulant factors were retained in the products [21].…”

Section: Introductionmentioning

confidence: 99%

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Caprylate/chromatography process to produce highly purified tetanus immune globulin from human plasma

et al. 2022

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While tetanus toxoid vaccination has reduced the incidence of tetanus in the developed world, this disease remains a substantial health problem in developing nations. Tetanus immune globulin (TIG) is used along with vaccination for prevention of infection after major or contaminated wounds if vaccination status cannot be verified or for active tetanus infection. These studies describe the characterisation of a TIG produced by a caprylate/chromatography process. The TIG potency and presence of plasma protein impurities were analysed at early/late steps in the manufacturing process by chromatography, immunoassay, coagulation and potency tests. The caprylate/chromatography process has been previously shown to effectively eliminate or inactivate potentially transmissible agents from plasma-derived products. In this study, the caprylate/chromatography process was shown to effectively concentrate TIG activity and efficiently remove pro-coagulation factors, naturally present in plasma. This TIG drug product builds on the long-term evidence of the safety and efficacy of TIG by providing a product with higher purity and low pro-coagulant protein impurities.

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