Hyperoncotic human albumin solutions for intravenous fluid therapy: Effectiveness of pathogen safety and purification methods, and clinical safety

Wiedermann, 2020, Phases of fluid management and the roles of human albumin solution in perioperative and critically ill patients, Curr. Med. Res. Opin., 36, 1961, 10.1080/03007995.2020.1840970 Zaccherini, 2019, The role and indications of albumin in advanced liver disease, Acta Gastroenterol. Belg., 82, 301 Bernardi, 2014, Role of human albumin in the management of complications of liver cirrhosis, J. Clin. Exp. Hepatol., 4, 302, 10.1016/j.jceh.2014.08.007 Caraceni, 2018, Long-term albumin administration in decompensated cirrhosis (ANSWER): An open-label randomised trial, Lancet, 391, 2417, 10.1016/S0140-6736(18)30840-7 Mårtensson, 2018, Small volume resuscitation with 20% albumin in intensive care: physiological effects: The SWIPE randomised clinical trial, Intensive Care Med., 44, 1797, 10.1007/s00134-018-5253-2 Vincent, 2003, Safety of human albumin—serious adverse events reported worldwide in 1998–2000†, Br. J. Anaesth., 91, 625, 10.1093/bja/aeg233 Caironi, 2014, Albumin replacement in patients with severe sepsis or septic shock, N. Engl. J. Med., 370, 1412, 10.1056/NEJMoa1305727 Finfer, 2011, Impact of albumin compared to saline on organ function and mortality of patients with severe sepsis, Intensive Care Med., 37, 86, 10.1007/s00134-010-2039-6 J. Charpentier, J.P. Mira, EARSS Study Group: Efficacy and tolerance of hyperoncotic albumin administration in septic shock patients: The EARSS study, Intensive Care Med. 37 (2011) S115-0438, https://doi.org/10.1007/s00134-011-2322-1. Russell, 2004, Albumin versus crystalloid for pump priming in cardiac surgery: meta-analysis of controlled trials, J. Cardiothorac. Vasc. Anesth., 18, 429, 10.1053/j.jvca.2004.05.019 Navickis, 2012, Effect of hydroxyethyl starch on bleeding after cardiopulmonary bypass: a meta-analysis of randomized trials, J. Thorac. Cardiovasc. Surg., 144, 223, 10.1016/j.jtcvs.2012.04.009 Bernardi, 2012, Human albumin in the management of complications of liver cirrhosis, Crit. Care, 16, 211, 10.1186/cc11218 Wiedermann, 2014, Albumin replacement in severe sepsis or septic shock, N. Engl. J. Med., 371, 83, 10.1056/NEJMc1405675 Wigmore, 2019, 20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients After Cardiac Surgery (the HAS FLAIR Study), J. Cardiothorac. Vasc. Anesth., 33, 2920, 10.1053/j.jvca.2019.03.049 Thomas-Rueddel, 2012, Safety of gelatin for volume resuscitation–a systematic review and meta-analysis, Intensive Care Med., 38, 1134, 10.1007/s00134-012-2560-x Zarychanski, 2013, Association of hydroxyethyl starch administration with mortality and acute kidney injury in critically ill patients requiring volume resuscitation: A systematic review and meta-analysis, J. Am. Med. Assoc., 309, 678, 10.1001/jama.2013.430 Haase, 2013, Hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin in patients with sepsis: systematic review with meta-analysis and trial sequential analysis, BMJ, 346, 10.1136/bmj.f839 Barron, 2004, A systematic review of the comparative safety of colloids, Arch. Surg., 139, 552, 10.1001/archsurg.139.5.552 von Hoegen, 2001, Safety of human albumin based on spontaneously reported serious adverse events, Crit. Care Med., 29, 994, 10.1097/00003246-200105000-00021 Yasumura, 2017, Evidence-based guidelines for the use of albumin products, Jpn. J. Transf. Cell Therapy, 63, 641 Xu, 2019, Chinese guidelines on the management of ascites and its related complications in cirrhosis, Hep. Intl., 13, 1, 10.1007/s12072-018-09923-2 2018, EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis, J. Hepatol., 69, 406, 10.1016/j.jhep.2018.03.024 Rhodes, 2017, Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016, Intensive Care Med., 43, 304, 10.1007/s00134-017-4683-6 Marx, 2016, Intravascular volume therapy in adults: Guidelines from the Association of the Scientific Medical Societies in Germany, Eur. J. Anaesthesiol., 33, 488, 10.1097/EJA.0000000000000447 Sümpelmann, 2017, Perioperative intravenous fluid therapy in children: guidelines from the Association of the Scientific Medical Societies in Germany, Paediatr. Anaesth., 27, 10, 10.1111/pan.13007 Liumbruno, 2009, Italian Society of Transfusion, Immunohaematology, Recommendations for the use of albumin and immunoglobulins, Blood Transfus., 7, 216 D.B. Kendrick. Blood program in World War II, Office of the Surgeon General, Dept. of the Army, Washington D.C., 1964. Matejtschuk, 2000, Production of human albumin solution: a continually developing colloid, Br. J. Anaesth., 85, 887, 10.1093/bja/85.6.887 Simon, 2020, Manufacturing of plasma-derived C1-inhibitor concentrate for treatment of patients with hereditary angioedema, Allergy Asthma Proc., 41, 99, 10.2500/aap.2020.41.190021 Gröner, 2012, Pathogen safety of human C1 esterase inhibitor concentrate, Transfusion, 52, 2104, 10.1111/j.1537-2995.2012.03590.x Gillet, 2018, An Original Approach to Evaluating the Quality of Blood Donor Selection: Checking Donor Questionnaires and Analyzing Donor Deferral Rate, Front. Med. (Lausanne)., 5, 74, 10.3389/fmed.2018.00074 Katz, 2007, Computer-based blood donor Screening: A status report, Transfus. Med. Rev., 21, 13, 10.1016/j.tmrv.2006.08.001 European Directorate for the Quality of Medicines & HealthCare (EDQM), Guide to the preparation, use and quality assurance of blood components, Recommendation No. R (95) 15, 19th edition (2017). ISBN: 978-92-871-8415-3. http://www.ipst.pt/files/IPST/INFORMACAO_DOCUMENTACAO/EDQM_Blood_transfusion_guide_19ed_2017_pub_PUBSD-89.pdf, 2017 (accessed 21 November 2022). U.S. Department of Health and Human Services. Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. Alternative procedures for blood and blood components during the COVID-19 public health emergency. FDA-2020-D-1137. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/alternative-procedures-blood-and-blood-components-during-covid-19-public-health-emergency, 2020 (accessed 21 November 2022). Plasma Protein Therapeutics Association (PPTA). QSEAL inventory hold standard. https://www.pptaglobal.org/images/qseal/QSEAL_Inventory_HoldV1-.pdf.pdf, 2013 (accessed 21 November 2022). Blümel, 2002, Inactivation of parvovirus B19 during pasteurization of human serum albumin, Transfusion, 42, 1011, 10.1046/j.1537-2995.2002.00158.x U.S. Food & Drug Administration (FDA), Guidance for industry: Nucleic acid testing (NAT) to reduce the possible risk of human parvovirus B19 transmission by plasma-derived products. https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Guidance-for-Industry---Nucleic-Acid-Testing--to-Reduce-the-Possible-Risk-of-Parvovirus-B19-Transmission-by-Plasma-Derived-Products.pdf, 2009 (accessed 21 November 2022). European Medicines Agency (EMA), Guideline on plasma-derived medicinal products. EMA/CHMP/BWP/706271/2010. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-plasma-derived-medicinal-products_en.pdf, 2011 (accessed 21 November 2022). World Health Organization (WHO), Guidelines on Hepatitis B and C Testing, ISBN: 978-92-4-154998-1. https://www.who.int/publications/i/item/9789241549981, 2017 (accessed 21 November 2022). European Medicines Agency (EMA). Guideline on epidemiological data on blood transmissible infections. EMA/CHMP/BWP/548524/2008 rev 1. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-epidemiological-data-blood-transmissible-infections-revision-1_en.pdf, 2016 (accessed 21 November 2022). Hu, 2018, 2, 31 Chamberland, 2001, Emerging Infectious Disease Issues in Blood Safety, Emerg. Infect. Dis., 7, 552, 10.3201/eid0707.017731 World Health Organization (WHO), Expert Committee on Biological Standardization, sixty-seventh report, Annex 4: Guidelines on estimation of residual risk of HIV, HBV or HCV infections via cellular blood components and plasma. https://cdn.who.int/media/docs/default-source/biologicals/blood-products/document-migration/resriskgl_who_trs_1004_web_annex_4.pdf?sfvrsn=55dd09d3_3, 2017 (accessed 21 November 2022). Bernardi, 2013, Manufacturing process and safety of current albumin products, 14 Raoufinia, 2016, Overview of albumin and its purification methods, Adv. Pharm. Bull., 6, 495, 10.15171/apb.2016.063 Burnouf, 2007, Modern plasma fractionation, Transfus. Med. Rev., 21, 101, 10.1016/j.tmrv.2006.11.001 Dichtelmüller, 2011, Contribution to safety of immunoglobulin and albumin from virus partitioning and inactivation by cold ethanol fractionation: a data collection from Plasma Protein Therapeutics Association member companies, Transfusion, 51, 1412, 10.1111/j.1537-2995.2010.03003.x European Medicines Agency (EMA) Committee for proprietary medicinal products (CPMP), Note for guidance on virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses. CPMP/BWP/268/95. https://www.ema.europa.eu/documents/scientific-guideline/note-guidance-virus-validation-studies-design-contribution-interpretation-studies-validating_en.pdf, 1996 (accessed 21 November 2022). Gröner, 2018, Effective inactivation of a wide range of viruses by pasteurization, Transfusion, 58, 41, 10.1111/trf.14390 Farcet, 2012, Inactivation of hepatitis A variants during heat treatment (pasteurization) of human serum albumin, Transfusion, 52, 181, 10.1111/j.1537-2995.2011.03251.x Yunoki, 2013, Hepatitis A virus strain KRM238 resistant at heat inactivation, Transfusion, 53, 2103, 10.1111/trf.12259 U.S. Food & Drug Administration (FDA). CFR – Code of Federal Regulations. Subpart H Albumin (Human). Title 21, Chapter I, Subchapter F, Part 640. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=640&showFR=1&subpartNode=21:7.0.1.1.7.8, 2022 (accessed 21 November 2022). Roth, 2015, Scientific Symposium of the Hemostasis and Thrombosis Research Society April 16–18, 2015 New Orleans, Louisiana, Haemophilia., 21, e273 Rabenau, 2005, SARS-coronavirus (SARS-CoV) and the safety of a solvent/detergent (S/D) treated immunoglobulin preparation, Biologicals, 33, 95, 10.1016/j.biologicals.2005.01.003 Lamarre, 1989, Effect of pH and temperature on the infectivity of human coronavirus 229E, Can. J. Microbiol., 35, 972, 10.1139/m89-160 Yunoki, 2004, Heat sensitivity of a SARS-associated coronavirus introduced into plasma products, Vox Sang., 87, 302, 10.1111/j.1423-0410.2004.00577.x Roth, 2020, Nanofiltration as a robust method contributing to viral safety of plasma-derived therapeutics: 20 years' experience of the plasma protein manufacturers, Transfusion, 60, 2661, 10.1111/trf.16022 Keil, 2016, Inactivation of Middle East respiratory syndrome coronavirus (MERS-CoV) in plasma products using a riboflavin-based and ultraviolet light-based photochemical treatment, Transfusion, 56, 2948, 10.1111/trf.13860 Wang, 2020, Detection of SARS-CoV-2 in Different Types of Clinical Specimens, J. Am. Med. Assoc., 323, 1843 Wölfel, 2020, Virological assessment of hospitalized patients with COVID-2019, Nature, 581, 465, 10.1038/s41586-020-2196-x Cappy, 2020, No evidence of SARS-CoV-2 transfusion transmission despite RNA detection in blood donors showing symptoms after donation, Blood, 136, 1888, 10.1182/blood.2020008230 Kwon, 2020, Post-donation COVID-19 identification in blood donors, Vox Sang., 115, 601, 10.1111/vox.12925 Cai, 2013, Prion removal capacity of plasma protein manufacturing processes: a data collection from PPTA member companies, Transfusion, 53, 1894, 10.1111/trf.12050 Foster, 2000, Studies on the removal of abnormal prion protein by processes used in the manufacture of human plasma products, Vox Sang., 78, 86, 10.1046/j.1423-0410.2000.7820086.x Lee, 2001, A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins, Transfusion, 41, 449, 10.1046/j.1537-2995.2001.41040449.x Thyer, 2006, Prion-removal capacity of chromatographic and ethanol precipitation steps used in the production of albumin and immunoglobulins, Vox Sang., 91, 292, 10.1111/j.1423-0410.2006.00829.x European Pharmacopoeia 9.0, Human albumin solution, 01/2013:0255. https://file.wuxuwang.com/yaopinbz/EP9/EP9.0_02__743.pdf, 2013 (accessed 21 November 2022). Chinese Pharmacopoeia Commission, Pharmacopoeia of the People’s Republic of China 2015, tenth edition, volume III, Human Albumin, 311 (English translation). https://www.webofpharma.com/2021/05/chinese-pharmacopoeia-in-english-cp-15.html, 2015 (accessed 21 November 2022). Agarwal, 2006, Practical approach to the diagnosis and treatment of anemia associated with CKD in elderly, J. Am. Med. Dir. Assoc., 7, S7, 10.1016/j.jamda.2006.09.005 Andress, 1986, Aluminum-associated bone disease in chronic renal failure: high prevalence in a long-term dialysis population, J. Bone Miner. Res., 1, 391, 10.1002/jbmr.5650010503 Rob, 2001, Dementia in patients undergoing long-term dialysis: aetiology, differential diagnoses, epidemiology and management, CNS Drugs, 15, 691, 10.2165/00023210-200115090-00003 Guo, 2019, Quality evaluation and research of human albumin, Zhongguo Yao Xue Za Zhi (Chin. Pharm. J.), 54, 734 Loeliger, 1985, Aluminum contamination of albumin-replacement solutions, N. Engl. J. Med., 312, 1389, 10.1056/NEJM198505233122114 Victor, 1988, Aluminum contamination in albumin solutions from glass storage, Transfusion, 28, 290, 10.1046/j.1537-2995.1988.28388219166.x May, 1992, Aluminum content of source plasma and sodium citrate anticoagulant, Vox Sang., 62, 65, 10.1111/j.1423-0410.1992.tb01172.x European Medicines Agency (EMA), Guideline on good pharmacovigilance practices (GVP), Module I - Pharmacovigilance systems and their quality systems. EMA/541760/2011. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-their-quality-systems_en.pdf, 2012 (accessed 21 November 2022). World Health Organization (WHO), Regulation and prequalification. What is pharmacovigilance? https://www.who.int/teams/regulation-prequalification/pharmacovigilance, 2021 (accessed 21 November 2022). Che, 2006, Impact of manufacturing improvements on clinical safety of albumin: Australian pharmacovigilance data for 1988–2005, Crit. Care Resusc., 8, 334 Hartmann, 2020, Supply and demand for plasma-derived medicinal products - A critical reassessment amid the COVID-19 pandemic, Transfusion, 60, 2748, 10.1111/trf.16078 He, 2011, Large-scale production of functional human serum albumin from transgenic rice seeds, PNAS, 108, 19078, 10.1073/pnas.1109736108 Ohnishi, 2008, A comparative pharmacokinetic study of recombinant human serum albumin with plasma-derived human serum albumin in patients with liver cirrhosis, J. Clin. Pharmacol., 48, 203, 10.1177/0091270007310549 Sharma, 2018, Physicochemical characterization of E. coli-derived human serum albumin and its comparison with the human plasma counterpart reveals it as a promising biosimilar, J. Biotechnol., 274, 1, 10.1016/j.jbiotec.2018.03.004