Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (fibryga (R))

Schulz Petra M.; Gehringer Werner; Noehring Sabine; Mueller Sebastian; Schmidt Torben; Kekeiss-Schertler Stephanie; Solomon Cristina; Pock Katharina; Roemisch Juergen

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Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (fibryga (R))

机译：一种新的纤维蛋白原浓缩物的生化表征，稳定性和病原体安全性（Fibryga（R））

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Fibryga (R) is a new lyophilized fibrinogen concentrate for intravenous use for the treatment of congenital fibrinogen deficiency. fibryga (R) is produced from pooled human plasma and the final product is characterized by high purity, integrity, and pathogen safety.

机译：Fibryga（R）是一种新的冻干纤维蛋白原浓缩物，用于静脉注射用于治疗先天性纤维蛋白原缺乏症。 Fibryga由合并的人血浆制备，最终产品的特征在于纯度，完整性和病原体安全性。

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来源
《Biologicals: Journal of the International Association of Biological Standardization》 |2018年第2018期|共6页
作者
Schulz Petra M.; Gehringer Werner; Noehring Sabine; Mueller Sebastian; Schmidt Torben; Kekeiss-Schertler Stephanie; Solomon Cristina; Pock Katharina; Roemisch Juergen;
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作者单位

Octapharma Pharmazeut Prod Gesellsch mbH R&

D Plasma Vienna Oberlaaerstr 235 A-1100 Vienna;

Octapharma Pharmazeut Prod Gesellsch mbH R&

D Plasma Vienna Oberlaaerstr 235 A-1100 Vienna;

Octapharma Biopharmaceut GmbH Mol Biochem Walther Nernst Str 3 D-12489 Berlin Germany;

Octapharma Biopharmaceut GmbH Virus &

Prion Validat Altenhoferallee 3 D-60438 Frankfurt Germany;

Octapharma Biopharmaceut GmbH Virus &

Prion Validat Altenhoferallee 3 D-60438 Frankfurt Germany;

Octapharma Pharmazeut Prod Gesellsch mbH R&

D Plasma Vienna Oberlaaerstr 235 A-1100 Vienna;

Octapharma AG Dept Res &

Dev Seidenstr 2 CH-8853 Lachen Switzerland;

Octapharma Pharmazeut Prod Gesellsch mbH R&

D Plasma Vienna Oberlaaerstr 235 A-1100 Vienna;

Octapharma Pharmazeut Prod Gesellsch mbH R&

D Plasma Vienna Oberlaaerstr 235 A-1100 Vienna;

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原文格式 PDF
正文语种 eng
中图分类生物科学;
关键词
Fibryga (R); Fibrinogen concentrate; Integrity; Safety; Stability;

机译：Fibryga（R）;纤维蛋白原浓缩物;完整性;安全;稳定性;

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专利

1. Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (fibryga (R)) [J] . Schulz Petra M., Gehringer Werner, Noehring Sabine, Biologicals: Journal of the International Association of Biological Standardization . 2018,第期

机译：一种新的纤维蛋白原浓缩物的生化表征，稳定性和病原体安全性（Fibryga（R））
2. Octanorm [cutaquig (R)], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) - Biochemical characterization, pathogen safety, and stability [J] . Gelbmann Nicola, Zoechling Alfred, Pichotta Alexander, Biologicals: Journal of the International Association of Biological Standardization . 2019,第期

机译：OctaNorm [Cutaquig（R）]，一种新的免疫球蛋白（人）皮下16.5％注射液（165mg / ml） - 生物化学表征，病原体安全性和稳定性
3. Biochemical characterization, pathogen safety and stability of Octanorm, a new 16.5% subcutaneous immune globulin product [J] . Gelbmann Nicola, Zoechling Alfred, Mersich Christa, Journal of Clinical Immunology . 2018,第3期

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4. Proteomics and transfusion medicine: Identification and quantification of chemical modifications induced by pathogen inactivation treatments and their impact on fibrinogen [C] . Alexia Ortiz, Fabrice Bray, Dominique Dernis, American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics . 2012

机译：蛋白质组学和输血药物：病原体灭活治疗诱导的化学修饰的鉴定和定量及其对纤维蛋白原的影响
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6. Fibrinogen concentrate for bleeding in patients with congenital fibrinogen deficiency: Observational study of efficacy and safety for prophylaxis and treatment [O] . Joseph Lasky, Jerome Teitel, Michael Wang, 2020

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7. Use of a new human fibrinogen concentrate (FIBRYGA®) In cardiac surgeries: first real-world experience in France based on temporary authorization [O] . F. Stéphan, L. Gutermann, M. Pennetier, 2020

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Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (fibryga (R))

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