RETRACTED: Pilot production of recombinant human clotting factor IX from transgenic sow milk

Sun, Yue; Chang, Yuo-Sheng; Lin, Yin-Shen; Yen, Chon-Ho

doi:10.1016/j.jchromb.2012.04.022

Cited by 6 publications

(2 citation statements)

References 31 publications

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“…Sun et al. showed a significant FIXa clearance using Heparin Sepharose® resin, because of the higher affinity of heparin to FIXa than to FIX . However, despite the similarities between Cellufine® Sulfate and heparin ligands, FIXa levels did not decrease in the present work (Table ).…”

Section: Intermediate Purification Based On Pseudo‐affinity Resin Chrcontrasting

confidence: 58%

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Intermediate purification of CHO‐derived recombinant human Factor IX using hydrophobic interaction membrane‐based chromatography and its comparison to a sulfated resin

et al. 2017

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This work investigated the use of hydrophobic interaction membrane chromatography for intermediate purification of recombinant human Factor IX (rFIX) produced by CHO cells. The first purification step was based on a strong anion exchange monolith, thus forming a purification process fully based on convective media, which allow operation at high flow rates and low pressure drops, as well as modular scale-up. Although the starting material was challenging (CHO cell culture supernatant harvested at 70% cell viability), the two-step purification process showed promising results, with a global purification factor of 298, a global recovery of 69%, and DNA and endotoxin levels close to regulatory limits. Final host cell DNA (68.8 ng per dose of 500 IU), endotoxins (60 EU per dose of 500 IU) and activated FIX (FIXa/FIX = 2.33%) were in levels close to those recommended by regulatory authorities. HCP removal was of 99.98%, decreasing from 9 424 358 ppm in the supernatant to a final HCP value of 2071 ppm. The use of a supernatant harvested at higher viability and/or the addition of a third polishing step focusing on HCP removal could allow meeting the desired HCP range of 50-100 ppm, as well as the regulatory requirements for the other critical contaminants.

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Section: Intermediate Purification Based On Pseudo‐affinity Resin Chrcontrasting

confidence: 58%

“…In terms of activated Factor IX levels, the ratio of FIXa/FIX after the Sartobind® Phenyl step was 2.33 ± 1.98%, thus in the same range as in the CIM Q monolith. According to the literature, a ratio below 2.4 is considered safe for patients .…”

Section: Intermediate Purification Based On Pseudo‐affinity Resin Chrmentioning

confidence: 99%

Intermediate purification of CHO‐derived recombinant human Factor IX using hydrophobic interaction membrane‐based chromatography and its comparison to a sulfated resin

et al. 2017

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Purification of Antibodies and Antibody Fragments Using CaptureSelect™ Affinity Resins

Hermans¹,

Adams²,

Detmers³

2014

Methods in Molecular Biology

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Ever since the introduction of bacterial derived surface proteins like protein A that demonstrate a natural binding reactivity towards antibodies, affinity chromatography has evolved into a well-established technology for the purification of antibodies and antibody fragments. Although high selectivity is provided by these types of affinity ligands, not all antibodies or antibody fragments are covered, which then forces the use of non-affinity-based processes that are less selective and often result in lower one-step purity and yield. To fill these gaps, we here describe a novel range of CaptureSelect(™) affinity resins that enables immunoaffinity chromatography for a much broader range of antibody targets.

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A galactopoiesis accordant yield of functional recombinant human factor IX from homozygous transgenic pigs requires a large amount of vitamin K supplementation

Yen¹,

Yang

Lin³

et al. 2016

Transgenic Res

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Transgenic pigs failed to accord milk yield curve to lactate rhFIX-a vitamin K (VK) dependent protein even fed with VK enriched to 8 times higher than nutritional requirement. A further higher VK supplementation may be required. Homozygous transgenic sows (n = 4, 200 kg) at their 3rd nursing were divided into control and treatment groups and respectively received VK enriched and further menadione (soluble VK) supplemented diet (220 mg/kg VK enriched diet) for 33 days. At next lactation, control sows than received treatment and previous treated were fed on control diet. Results revealed that menadione treatment increased milk bioactivity of rhFIX from the 7th day of 73 to the 21st day of 153 IU/mL; it gradually decreased to 96 IU/mL on 35th day of lactation. Under control feeding, bioactivity remained relatively unchanged. However, milk rhFIX concentration and ratio of activated rhFIX responded little to the treatment. The menadione-induced bioactivity curve agrees with the known lactation pattern of sow means rhFIX secretion is still galactopoietic but requires high VK intake to show. The ineffectual VK spend on lactational carboxylation might be common in other mammary VK dependent expression system but can be effectively overcome by a high supplementation of menadione with a 5-folds improvement in quality.

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RETRACTED: Pilot production of recombinant human clotting factor IX from transgenic sow milk

Cited by 6 publications

References 31 publications

Intermediate purification of CHO‐derived recombinant human Factor IX using hydrophobic interaction membrane‐based chromatography and its comparison to a sulfated resin

Intermediate purification of CHO‐derived recombinant human Factor IX using hydrophobic interaction membrane‐based chromatography and its comparison to a sulfated resin

Purification of Antibodies and Antibody Fragments Using CaptureSelect™ Affinity Resins

A galactopoiesis accordant yield of functional recombinant human factor IX from homozygous transgenic pigs requires a large amount of vitamin K supplementation

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