On the Separation of Yttrium-90 from High-Level Liquid Waste: Purification to Clinical-Grade Radiochemical Precursor, Clinical Translation in Formulation of 90 Y-DOTATATE Patient Dose
The quality control parameters of in-house-produced Y-Acetate from high-level liquid waste (HLLW) using supported liquid membrane (SLM) technology were validated and compared with the pharmacopeia standard. The radiolabeling of DOTATATE yielding Y-DOTATATE in acceptable radiochemical purity (RCP), w...
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| Veröffentlicht in: | Cancer biotherapy & radiopharmaceuticals 2021-03, Vol.36 (2), p.143-159 |
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| creator | Mitra, Arpit Chakraborty, Avik Gaikwad, Sujay Tawate, Megha Upadhye, Trupti Lad, Sangita Sahoo, Sudip Jagesia, Poonam Parghane, Rahul Menon, Sreeja Basu, Sandip Dhami, Prem Singh Banerjee, Sharmila |
| description | The quality control parameters of in-house-produced
Y-Acetate from high-level liquid waste (HLLW) using supported liquid membrane (SLM) technology were validated and compared with the pharmacopeia standard. The radiolabeling of DOTATATE yielding
Y-DOTATATE in acceptable radiochemical purity (RCP), with expected pharmacological behavior in
models, establish the quality of
Y-Acetate. Clinical translation of
Y-Acetate in formulation of
Y-DOTATATE adds support toward its use as clinical-grade radiochemical.
Quality control parameters of
Y-Acetate, namely radionuclide purity (RNP), were evaluated using β
spectrometry, γ-spectroscopy, and liquid scintillation counting. RCP and metallic impurities were established using high-performance liquid chromatography and inductively coupled plasma optical emission spectrometry, respectively. The suitability of
Y-Acetate as an active pharmaceutical ingredient radiochemical was ascertained by radiolabeling with DOTATATE.
biodistribution of
Y-DOTATATE was carried out in nude mice bearing AR42J xenografted tumor. Clinical efficacy of
Y-DOTATATE was established after using in patients with large-volume neuroendocrine tumors (NET). Bremsstrahlung imaging was carried out in dual-head gamma camera with a wide energy window setting (100-250 keV).
In-house-produced
Y-Acetate was clear, colorless, and radioactive concentration (RAC) in the range of 40-50 mCi/mL. RCP was >98%.
Sr content was |
| doi_str_mv | 10.1089/cbr.2020.4092 |
| format | Article |
| fullrecord | <record><control><sourceid>pubmed_cross</sourceid><recordid>TN_cdi_crossref_primary_10_1089_cbr_2020_4092</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>33750229</sourcerecordid><originalsourceid>FETCH-LOGICAL-c1059-c45c65c2584fe4ca1b774b662a775420880bb85fddcfa97903fd2a3b637636643</originalsourceid><addsrcrecordid>eNo9UctOwzAQtBCIR-HIFfkDcNk48SPcUIGCVKkVFCFOkePY1CiJi50g8WX8HqkK1R52dzSzu9pB6DyBcQIyv9JlGFOgMM4gp3voOGFMECkZ3R9qkBnJhWRH6CTGDwDgwMUhOkpTwYDS_Bj9zFvcrQx-NmsVVOd8i73Fb10XXN-QHLANvsEP7n1FZubL1HjmPntX4VcVO3ONF31w1umtsPN4Urt2aGsyDaoy-ElVzuuVaTYYXgSj-xB9uNzx8DKoNtZbvWvxvQ9NX-_uGPa_kdv58maIO7wYcNN2-NZHc4oOrKqjOfvLI_Ryf7ecPJDZfPo4uZkRnQDLic6Y5kxTJjNrMq2SUois5JwqIVhGQUooS8lsVWmrcpFDaiuq0pKngqecZ-kIke1cHXyMwdhiHVyjwneRQLExoBgMKDYGFBsDBv7Flr_uy8ZUO_b_x9NfPRCCNQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>On the Separation of Yttrium-90 from High-Level Liquid Waste: Purification to Clinical-Grade Radiochemical Precursor, Clinical Translation in Formulation of 90 Y-DOTATATE Patient Dose</title><source>Alma/SFX Local Collection</source><creator>Mitra, Arpit ; Chakraborty, Avik ; Gaikwad, Sujay ; Tawate, Megha ; Upadhye, Trupti ; Lad, Sangita ; Sahoo, Sudip ; Jagesia, Poonam ; Parghane, Rahul ; Menon, Sreeja ; Basu, Sandip ; Dhami, Prem Singh ; Banerjee, Sharmila</creator><creatorcontrib>Mitra, Arpit ; Chakraborty, Avik ; Gaikwad, Sujay ; Tawate, Megha ; Upadhye, Trupti ; Lad, Sangita ; Sahoo, Sudip ; Jagesia, Poonam ; Parghane, Rahul ; Menon, Sreeja ; Basu, Sandip ; Dhami, Prem Singh ; Banerjee, Sharmila</creatorcontrib><description>The quality control parameters of in-house-produced
Y-Acetate from high-level liquid waste (HLLW) using supported liquid membrane (SLM) technology were validated and compared with the pharmacopeia standard. The radiolabeling of DOTATATE yielding
Y-DOTATATE in acceptable radiochemical purity (RCP), with expected pharmacological behavior in
models, establish the quality of
Y-Acetate. Clinical translation of
Y-Acetate in formulation of
Y-DOTATATE adds support toward its use as clinical-grade radiochemical.
Quality control parameters of
Y-Acetate, namely radionuclide purity (RNP), were evaluated using β
spectrometry, γ-spectroscopy, and liquid scintillation counting. RCP and metallic impurities were established using high-performance liquid chromatography and inductively coupled plasma optical emission spectrometry, respectively. The suitability of
Y-Acetate as an active pharmaceutical ingredient radiochemical was ascertained by radiolabeling with DOTATATE.
biodistribution of
Y-DOTATATE was carried out in nude mice bearing AR42J xenografted tumor. Clinical efficacy of
Y-DOTATATE was established after using in patients with large-volume neuroendocrine tumors (NET). Bremsstrahlung imaging was carried out in dual-head gamma camera with a wide energy window setting (100-250 keV).
In-house-produced
Y-Acetate was clear, colorless, and radioactive concentration (RAC) in the range of 40-50 mCi/mL. RCP was >98%.
Sr content was <0.85 μCi/Ci of
Y. Gross λ content was <0.8 nCi/Ci of
Y and no γ peak was observed. Fe
, Cu
, Zn
, Cd
, and Pb
contents were <1.7 μg/Ci. The radiolabeling yield (RLY) of
Y-DOTATATE was >94%, RCP was >98%. The
stability of
Y-DOTATATE was up to 72 h postradiolabeling, upon storage at -20°C. Post-therapy (24 h) Bremsstrahlung image of patients with large NET exhibit complete localization of
Y-DOTATATE in tumor region.
This study demonstrates that the in-house-produced
Y-Acetate from HLLW can be used for the formulation of various therapeutic
Y-based radiopharmaceuticals. Since
Y is an imported radiochemical precursor available at a high cost in India, this study which demonstrates the suitability of indigenously sourced
Y, ideally exemplifies the recovery of "wealth from waste." The Clinical Trial Registration number: (P17/FEB/2019).</description><identifier>ISSN: 1084-9785</identifier><identifier>EISSN: 1557-8852</identifier><identifier>DOI: 10.1089/cbr.2020.4092</identifier><identifier>PMID: 33750229</identifier><language>eng</language><publisher>United States</publisher><ispartof>Cancer biotherapy & radiopharmaceuticals, 2021-03, Vol.36 (2), p.143-159</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c1059-c45c65c2584fe4ca1b774b662a775420880bb85fddcfa97903fd2a3b637636643</citedby><cites>FETCH-LOGICAL-c1059-c45c65c2584fe4ca1b774b662a775420880bb85fddcfa97903fd2a3b637636643</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33750229$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mitra, Arpit</creatorcontrib><creatorcontrib>Chakraborty, Avik</creatorcontrib><creatorcontrib>Gaikwad, Sujay</creatorcontrib><creatorcontrib>Tawate, Megha</creatorcontrib><creatorcontrib>Upadhye, Trupti</creatorcontrib><creatorcontrib>Lad, Sangita</creatorcontrib><creatorcontrib>Sahoo, Sudip</creatorcontrib><creatorcontrib>Jagesia, Poonam</creatorcontrib><creatorcontrib>Parghane, Rahul</creatorcontrib><creatorcontrib>Menon, Sreeja</creatorcontrib><creatorcontrib>Basu, Sandip</creatorcontrib><creatorcontrib>Dhami, Prem Singh</creatorcontrib><creatorcontrib>Banerjee, Sharmila</creatorcontrib><title>On the Separation of Yttrium-90 from High-Level Liquid Waste: Purification to Clinical-Grade Radiochemical Precursor, Clinical Translation in Formulation of 90 Y-DOTATATE Patient Dose</title><title>Cancer biotherapy & radiopharmaceuticals</title><addtitle>Cancer Biother Radiopharm</addtitle><description>The quality control parameters of in-house-produced
Y-Acetate from high-level liquid waste (HLLW) using supported liquid membrane (SLM) technology were validated and compared with the pharmacopeia standard. The radiolabeling of DOTATATE yielding
Y-DOTATATE in acceptable radiochemical purity (RCP), with expected pharmacological behavior in
models, establish the quality of
Y-Acetate. Clinical translation of
Y-Acetate in formulation of
Y-DOTATATE adds support toward its use as clinical-grade radiochemical.
Quality control parameters of
Y-Acetate, namely radionuclide purity (RNP), were evaluated using β
spectrometry, γ-spectroscopy, and liquid scintillation counting. RCP and metallic impurities were established using high-performance liquid chromatography and inductively coupled plasma optical emission spectrometry, respectively. The suitability of
Y-Acetate as an active pharmaceutical ingredient radiochemical was ascertained by radiolabeling with DOTATATE.
biodistribution of
Y-DOTATATE was carried out in nude mice bearing AR42J xenografted tumor. Clinical efficacy of
Y-DOTATATE was established after using in patients with large-volume neuroendocrine tumors (NET). Bremsstrahlung imaging was carried out in dual-head gamma camera with a wide energy window setting (100-250 keV).
In-house-produced
Y-Acetate was clear, colorless, and radioactive concentration (RAC) in the range of 40-50 mCi/mL. RCP was >98%.
Sr content was <0.85 μCi/Ci of
Y. Gross λ content was <0.8 nCi/Ci of
Y and no γ peak was observed. Fe
, Cu
, Zn
, Cd
, and Pb
contents were <1.7 μg/Ci. The radiolabeling yield (RLY) of
Y-DOTATATE was >94%, RCP was >98%. The
stability of
Y-DOTATATE was up to 72 h postradiolabeling, upon storage at -20°C. Post-therapy (24 h) Bremsstrahlung image of patients with large NET exhibit complete localization of
Y-DOTATATE in tumor region.
This study demonstrates that the in-house-produced
Y-Acetate from HLLW can be used for the formulation of various therapeutic
Y-based radiopharmaceuticals. Since
Y is an imported radiochemical precursor available at a high cost in India, this study which demonstrates the suitability of indigenously sourced
Y, ideally exemplifies the recovery of "wealth from waste." The Clinical Trial Registration number: (P17/FEB/2019).</description><issn>1084-9785</issn><issn>1557-8852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNo9UctOwzAQtBCIR-HIFfkDcNk48SPcUIGCVKkVFCFOkePY1CiJi50g8WX8HqkK1R52dzSzu9pB6DyBcQIyv9JlGFOgMM4gp3voOGFMECkZ3R9qkBnJhWRH6CTGDwDgwMUhOkpTwYDS_Bj9zFvcrQx-NmsVVOd8i73Fb10XXN-QHLANvsEP7n1FZubL1HjmPntX4VcVO3ONF31w1umtsPN4Urt2aGsyDaoy-ElVzuuVaTYYXgSj-xB9uNzx8DKoNtZbvWvxvQ9NX-_uGPa_kdv58maIO7wYcNN2-NZHc4oOrKqjOfvLI_Ryf7ecPJDZfPo4uZkRnQDLic6Y5kxTJjNrMq2SUois5JwqIVhGQUooS8lsVWmrcpFDaiuq0pKngqecZ-kIke1cHXyMwdhiHVyjwneRQLExoBgMKDYGFBsDBv7Flr_uy8ZUO_b_x9NfPRCCNQ</recordid><startdate>202103</startdate><enddate>202103</enddate><creator>Mitra, Arpit</creator><creator>Chakraborty, Avik</creator><creator>Gaikwad, Sujay</creator><creator>Tawate, Megha</creator><creator>Upadhye, Trupti</creator><creator>Lad, Sangita</creator><creator>Sahoo, Sudip</creator><creator>Jagesia, Poonam</creator><creator>Parghane, Rahul</creator><creator>Menon, Sreeja</creator><creator>Basu, Sandip</creator><creator>Dhami, Prem Singh</creator><creator>Banerjee, Sharmila</creator><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>202103</creationdate><title>On the Separation of Yttrium-90 from High-Level Liquid Waste: Purification to Clinical-Grade Radiochemical Precursor, Clinical Translation in Formulation of 90 Y-DOTATATE Patient Dose</title><author>Mitra, Arpit ; Chakraborty, Avik ; Gaikwad, Sujay ; Tawate, Megha ; Upadhye, Trupti ; Lad, Sangita ; Sahoo, Sudip ; Jagesia, Poonam ; Parghane, Rahul ; Menon, Sreeja ; Basu, Sandip ; Dhami, Prem Singh ; Banerjee, Sharmila</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1059-c45c65c2584fe4ca1b774b662a775420880bb85fddcfa97903fd2a3b637636643</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mitra, Arpit</creatorcontrib><creatorcontrib>Chakraborty, Avik</creatorcontrib><creatorcontrib>Gaikwad, Sujay</creatorcontrib><creatorcontrib>Tawate, Megha</creatorcontrib><creatorcontrib>Upadhye, Trupti</creatorcontrib><creatorcontrib>Lad, Sangita</creatorcontrib><creatorcontrib>Sahoo, Sudip</creatorcontrib><creatorcontrib>Jagesia, Poonam</creatorcontrib><creatorcontrib>Parghane, Rahul</creatorcontrib><creatorcontrib>Menon, Sreeja</creatorcontrib><creatorcontrib>Basu, Sandip</creatorcontrib><creatorcontrib>Dhami, Prem Singh</creatorcontrib><creatorcontrib>Banerjee, Sharmila</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Cancer biotherapy & radiopharmaceuticals</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mitra, Arpit</au><au>Chakraborty, Avik</au><au>Gaikwad, Sujay</au><au>Tawate, Megha</au><au>Upadhye, Trupti</au><au>Lad, Sangita</au><au>Sahoo, Sudip</au><au>Jagesia, Poonam</au><au>Parghane, Rahul</au><au>Menon, Sreeja</au><au>Basu, Sandip</au><au>Dhami, Prem Singh</au><au>Banerjee, Sharmila</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>On the Separation of Yttrium-90 from High-Level Liquid Waste: Purification to Clinical-Grade Radiochemical Precursor, Clinical Translation in Formulation of 90 Y-DOTATATE Patient Dose</atitle><jtitle>Cancer biotherapy & radiopharmaceuticals</jtitle><addtitle>Cancer Biother Radiopharm</addtitle><date>2021-03</date><risdate>2021</risdate><volume>36</volume><issue>2</issue><spage>143</spage><epage>159</epage><pages>143-159</pages><issn>1084-9785</issn><eissn>1557-8852</eissn><abstract>The quality control parameters of in-house-produced
Y-Acetate from high-level liquid waste (HLLW) using supported liquid membrane (SLM) technology were validated and compared with the pharmacopeia standard. The radiolabeling of DOTATATE yielding
Y-DOTATATE in acceptable radiochemical purity (RCP), with expected pharmacological behavior in
models, establish the quality of
Y-Acetate. Clinical translation of
Y-Acetate in formulation of
Y-DOTATATE adds support toward its use as clinical-grade radiochemical.
Quality control parameters of
Y-Acetate, namely radionuclide purity (RNP), were evaluated using β
spectrometry, γ-spectroscopy, and liquid scintillation counting. RCP and metallic impurities were established using high-performance liquid chromatography and inductively coupled plasma optical emission spectrometry, respectively. The suitability of
Y-Acetate as an active pharmaceutical ingredient radiochemical was ascertained by radiolabeling with DOTATATE.
biodistribution of
Y-DOTATATE was carried out in nude mice bearing AR42J xenografted tumor. Clinical efficacy of
Y-DOTATATE was established after using in patients with large-volume neuroendocrine tumors (NET). Bremsstrahlung imaging was carried out in dual-head gamma camera with a wide energy window setting (100-250 keV).
In-house-produced
Y-Acetate was clear, colorless, and radioactive concentration (RAC) in the range of 40-50 mCi/mL. RCP was >98%.
Sr content was <0.85 μCi/Ci of
Y. Gross λ content was <0.8 nCi/Ci of
Y and no γ peak was observed. Fe
, Cu
, Zn
, Cd
, and Pb
contents were <1.7 μg/Ci. The radiolabeling yield (RLY) of
Y-DOTATATE was >94%, RCP was >98%. The
stability of
Y-DOTATATE was up to 72 h postradiolabeling, upon storage at -20°C. Post-therapy (24 h) Bremsstrahlung image of patients with large NET exhibit complete localization of
Y-DOTATATE in tumor region.
This study demonstrates that the in-house-produced
Y-Acetate from HLLW can be used for the formulation of various therapeutic
Y-based radiopharmaceuticals. Since
Y is an imported radiochemical precursor available at a high cost in India, this study which demonstrates the suitability of indigenously sourced
Y, ideally exemplifies the recovery of "wealth from waste." The Clinical Trial Registration number: (P17/FEB/2019).</abstract><cop>United States</cop><pmid>33750229</pmid><doi>10.1089/cbr.2020.4092</doi><tpages>17</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Cancer biotherapy & radiopharmaceuticals, 2021-03, Vol.36 (2), p.143-159 |
| issn | 1084-9785 1557-8852 |
| language | eng |
| recordid | cdi_crossref_primary_10_1089_cbr_2020_4092 |
| source | Alma/SFX Local Collection |
| title | On the Separation of Yttrium-90 from High-Level Liquid Waste: Purification to Clinical-Grade Radiochemical Precursor, Clinical Translation in Formulation of 90 Y-DOTATATE Patient Dose |
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