Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials
ObjectivesAggregation is one of the key critical points limiting the stability of monoclonal antibodies in solution. The present study aimed to investigate the in-use stability of a residual monoclonal antibody solution after withdrawal of most of the filling volume of PF-06439535 (bevacizumab biosi...
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| Veröffentlicht in: | European journal of hospital pharmacy. Science and practice 2022-07, Vol.31 (2), p.135-142 |
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| creator | Abdel-Tawab, Mona Waßmuth, Markus Gegenfurtner, Florian Hawe, Andrea Schefe, Jan H Strunz, Anke M Wübert, Joachim |
| description | ObjectivesAggregation is one of the key critical points limiting the stability of monoclonal antibodies in solution. The present study aimed to investigate the in-use stability of a residual monoclonal antibody solution after withdrawal of most of the filling volume of PF-06439535 (bevacizumab biosimilar), addressing the physical and chemical stability with respect to aggregation and fragmentation.MethodsThe stability of residual PF-06439535 solution (25 mg/mL) after withdrawal of 80% (12.8 mL) filling volume with a 20G needle was monitored over a light-protected storage period of 8 days at 2–8°C and 25°C with measurement time points at D0 (start of storage), D2, D4, and D8 (2, 4, and 8 days of storage after start, respectively). Unopened vials stored under the same conditions served as control. For this purpose, the analytical results from size exclusion chromatography, dynamic light scattering, and micro-flow imaging obtained after the individual measurement time points up to 8 days were compared with those obtained at D0 and with those obtained for unopened vials stored under the same conditions.ResultsNo aggregation or ongoing fragmentation due to partial withdrawal of filling volume could be observed in the residual PF-06439535 solution. Moreover, no changes in the particle size distribution at D8 compared with the D0 values were identified upon storage at either 2–8°C or 25°C (both opened and unopened vials). The total concentration of particles ≥10 µm of all samples was |
| doi_str_mv | 10.1136/ejhpharm-2021-003198 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10895173</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2692070805</sourcerecordid><originalsourceid>FETCH-LOGICAL-b506t-d6ff6df237a927ad5b89ec2f6166ff9c292abc5c9dc6e9c191e77030e972c8bc3</originalsourceid><addsrcrecordid>eNp9kd9LHDEQx0NpqXL6H4gs-NKXtPmxSXaepIi2glChio8hyWa9HLuba7J7YP_6Rk5P7YNPk2Q-883MfBE6ouQrpVx-86vlemnSgBlhFBPCKTQf0D4jtcIAsv64Owu5hw5zDpYIzhuoOXxGe1w0gktg--ju9zKmCU8-DVWe5vahimMVRjxnX-7Ghj5M5a2r4tqPvq2s3xgX_s6DsZUNMYch9CZV1xeYyKItuKg2wfT5AH3qSvCHT3GBbi_Ob85-4qtfPy7Pvl9hK4iccCu7TrYd48oAU6YVtgHvWCepLBlwDJixTjhonfTgKFCvFOHEg2KusY4v0OlWdz3bwbfOj1MyvV6nMJj0oKMJ-m1mDEt9HzeakgYEVbwofHlSSPHP7POkh5Cd73sz-jhnzcqeiCJN2d8CnfyHruKcxjKfLo2CqIVU8l1KAm0ECAWFqreUSzHn5Ltdz5ToR4_1s8f60WO99biUHb-ed1f07GgByBaww-rl43c1_wF-ILNq</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2691859579</pqid></control><display><type>article</type><title>Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials</title><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>Abdel-Tawab, Mona ; Waßmuth, Markus ; Gegenfurtner, Florian ; Hawe, Andrea ; Schefe, Jan H ; Strunz, Anke M ; Wübert, Joachim</creator><creatorcontrib>Abdel-Tawab, Mona ; Waßmuth, Markus ; Gegenfurtner, Florian ; Hawe, Andrea ; Schefe, Jan H ; Strunz, Anke M ; Wübert, Joachim</creatorcontrib><description>ObjectivesAggregation is one of the key critical points limiting the stability of monoclonal antibodies in solution. The present study aimed to investigate the in-use stability of a residual monoclonal antibody solution after withdrawal of most of the filling volume of PF-06439535 (bevacizumab biosimilar), addressing the physical and chemical stability with respect to aggregation and fragmentation.MethodsThe stability of residual PF-06439535 solution (25 mg/mL) after withdrawal of 80% (12.8 mL) filling volume with a 20G needle was monitored over a light-protected storage period of 8 days at 2–8°C and 25°C with measurement time points at D0 (start of storage), D2, D4, and D8 (2, 4, and 8 days of storage after start, respectively). Unopened vials stored under the same conditions served as control. For this purpose, the analytical results from size exclusion chromatography, dynamic light scattering, and micro-flow imaging obtained after the individual measurement time points up to 8 days were compared with those obtained at D0 and with those obtained for unopened vials stored under the same conditions.ResultsNo aggregation or ongoing fragmentation due to partial withdrawal of filling volume could be observed in the residual PF-06439535 solution. Moreover, no changes in the particle size distribution at D8 compared with the D0 values were identified upon storage at either 2–8°C or 25°C (both opened and unopened vials). The total concentration of particles ≥10 µm of all samples was <100 particles/mL. In addition, no variations in the pH values or in the visual appearance were detected over the whole study period in all samples at all storage conditions.ConclusionsConsequently, residual PF-06439535 solution (25 mg/mL) in opened vials may be regarded as stable when stored light-protected over a period of 8 days in the refrigerator (2–8°C) or at 25°C.</description><identifier>ISSN: 2047-9956</identifier><identifier>EISSN: 2047-9964</identifier><identifier>DOI: 10.1136/ejhpharm-2021-003198</identifier><identifier>PMID: 35853692</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>Biological products ; Caustic soda ; Chromatography ; CLINICAL MEDICINE ; Drug Monitoring ; Light ; MEDICAL ONCOLOGY ; Molecular weight ; Monoclonal antibodies ; OPHTHALMOLOGY ; Original Research ; Particle size ; Patient safety ; PHARMACEUTICAL PREPARATIONS ; Vascular endothelial growth factor</subject><ispartof>European journal of hospital pharmacy. Science and practice, 2022-07, Vol.31 (2), p.135-142</ispartof><rights>European Association of Hospital Pharmacists 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.</rights><rights>European Association of Hospital Pharmacists 2022. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.</rights><rights>2022 European Association of Hospital Pharmacists 2022. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2024 European Association of Hospital Pharmacists 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>European Association of Hospital Pharmacists 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b506t-d6ff6df237a927ad5b89ec2f6166ff9c292abc5c9dc6e9c191e77030e972c8bc3</citedby><cites>FETCH-LOGICAL-b506t-d6ff6df237a927ad5b89ec2f6166ff9c292abc5c9dc6e9c191e77030e972c8bc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10895173/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10895173/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35853692$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Abdel-Tawab, Mona</creatorcontrib><creatorcontrib>Waßmuth, Markus</creatorcontrib><creatorcontrib>Gegenfurtner, Florian</creatorcontrib><creatorcontrib>Hawe, Andrea</creatorcontrib><creatorcontrib>Schefe, Jan H</creatorcontrib><creatorcontrib>Strunz, Anke M</creatorcontrib><creatorcontrib>Wübert, Joachim</creatorcontrib><title>Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials</title><title>European journal of hospital pharmacy. Science and practice</title><addtitle>Eur J Hosp Pharm</addtitle><addtitle>Eur J Hosp Pharm</addtitle><description>ObjectivesAggregation is one of the key critical points limiting the stability of monoclonal antibodies in solution. The present study aimed to investigate the in-use stability of a residual monoclonal antibody solution after withdrawal of most of the filling volume of PF-06439535 (bevacizumab biosimilar), addressing the physical and chemical stability with respect to aggregation and fragmentation.MethodsThe stability of residual PF-06439535 solution (25 mg/mL) after withdrawal of 80% (12.8 mL) filling volume with a 20G needle was monitored over a light-protected storage period of 8 days at 2–8°C and 25°C with measurement time points at D0 (start of storage), D2, D4, and D8 (2, 4, and 8 days of storage after start, respectively). Unopened vials stored under the same conditions served as control. For this purpose, the analytical results from size exclusion chromatography, dynamic light scattering, and micro-flow imaging obtained after the individual measurement time points up to 8 days were compared with those obtained at D0 and with those obtained for unopened vials stored under the same conditions.ResultsNo aggregation or ongoing fragmentation due to partial withdrawal of filling volume could be observed in the residual PF-06439535 solution. Moreover, no changes in the particle size distribution at D8 compared with the D0 values were identified upon storage at either 2–8°C or 25°C (both opened and unopened vials). The total concentration of particles ≥10 µm of all samples was <100 particles/mL. In addition, no variations in the pH values or in the visual appearance were detected over the whole study period in all samples at all storage conditions.ConclusionsConsequently, residual PF-06439535 solution (25 mg/mL) in opened vials may be regarded as stable when stored light-protected over a period of 8 days in the refrigerator (2–8°C) or at 25°C.</description><subject>Biological products</subject><subject>Caustic soda</subject><subject>Chromatography</subject><subject>CLINICAL MEDICINE</subject><subject>Drug Monitoring</subject><subject>Light</subject><subject>MEDICAL ONCOLOGY</subject><subject>Molecular weight</subject><subject>Monoclonal antibodies</subject><subject>OPHTHALMOLOGY</subject><subject>Original Research</subject><subject>Particle size</subject><subject>Patient safety</subject><subject>PHARMACEUTICAL PREPARATIONS</subject><subject>Vascular endothelial growth factor</subject><issn>2047-9956</issn><issn>2047-9964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kd9LHDEQx0NpqXL6H4gs-NKXtPmxSXaepIi2glChio8hyWa9HLuba7J7YP_6Rk5P7YNPk2Q-883MfBE6ouQrpVx-86vlemnSgBlhFBPCKTQf0D4jtcIAsv64Owu5hw5zDpYIzhuoOXxGe1w0gktg--ju9zKmCU8-DVWe5vahimMVRjxnX-7Ghj5M5a2r4tqPvq2s3xgX_s6DsZUNMYch9CZV1xeYyKItuKg2wfT5AH3qSvCHT3GBbi_Ob85-4qtfPy7Pvl9hK4iccCu7TrYd48oAU6YVtgHvWCepLBlwDJixTjhonfTgKFCvFOHEg2KusY4v0OlWdz3bwbfOj1MyvV6nMJj0oKMJ-m1mDEt9HzeakgYEVbwofHlSSPHP7POkh5Cd73sz-jhnzcqeiCJN2d8CnfyHruKcxjKfLo2CqIVU8l1KAm0ECAWFqreUSzHn5Ltdz5ToR4_1s8f60WO99biUHb-ed1f07GgByBaww-rl43c1_wF-ILNq</recordid><startdate>20220719</startdate><enddate>20220719</enddate><creator>Abdel-Tawab, Mona</creator><creator>Waßmuth, Markus</creator><creator>Gegenfurtner, Florian</creator><creator>Hawe, Andrea</creator><creator>Schefe, Jan H</creator><creator>Strunz, Anke M</creator><creator>Wübert, Joachim</creator><general>British Medical Journal Publishing Group</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20220719</creationdate><title>Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials</title><author>Abdel-Tawab, Mona ; Waßmuth, Markus ; Gegenfurtner, Florian ; Hawe, Andrea ; Schefe, Jan H ; Strunz, Anke M ; Wübert, Joachim</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b506t-d6ff6df237a927ad5b89ec2f6166ff9c292abc5c9dc6e9c191e77030e972c8bc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Biological products</topic><topic>Caustic soda</topic><topic>Chromatography</topic><topic>CLINICAL MEDICINE</topic><topic>Drug Monitoring</topic><topic>Light</topic><topic>MEDICAL ONCOLOGY</topic><topic>Molecular weight</topic><topic>Monoclonal antibodies</topic><topic>OPHTHALMOLOGY</topic><topic>Original Research</topic><topic>Particle size</topic><topic>Patient safety</topic><topic>PHARMACEUTICAL PREPARATIONS</topic><topic>Vascular endothelial growth factor</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Abdel-Tawab, Mona</creatorcontrib><creatorcontrib>Waßmuth, Markus</creatorcontrib><creatorcontrib>Gegenfurtner, Florian</creatorcontrib><creatorcontrib>Hawe, Andrea</creatorcontrib><creatorcontrib>Schefe, Jan H</creatorcontrib><creatorcontrib>Strunz, Anke M</creatorcontrib><creatorcontrib>Wübert, Joachim</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European journal of hospital pharmacy. Science and practice</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Abdel-Tawab, Mona</au><au>Waßmuth, Markus</au><au>Gegenfurtner, Florian</au><au>Hawe, Andrea</au><au>Schefe, Jan H</au><au>Strunz, Anke M</au><au>Wübert, Joachim</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials</atitle><jtitle>European journal of hospital pharmacy. Science and practice</jtitle><stitle>Eur J Hosp Pharm</stitle><addtitle>Eur J Hosp Pharm</addtitle><date>2022-07-19</date><risdate>2022</risdate><volume>31</volume><issue>2</issue><spage>135</spage><epage>142</epage><pages>135-142</pages><issn>2047-9956</issn><eissn>2047-9964</eissn><abstract>ObjectivesAggregation is one of the key critical points limiting the stability of monoclonal antibodies in solution. The present study aimed to investigate the in-use stability of a residual monoclonal antibody solution after withdrawal of most of the filling volume of PF-06439535 (bevacizumab biosimilar), addressing the physical and chemical stability with respect to aggregation and fragmentation.MethodsThe stability of residual PF-06439535 solution (25 mg/mL) after withdrawal of 80% (12.8 mL) filling volume with a 20G needle was monitored over a light-protected storage period of 8 days at 2–8°C and 25°C with measurement time points at D0 (start of storage), D2, D4, and D8 (2, 4, and 8 days of storage after start, respectively). Unopened vials stored under the same conditions served as control. For this purpose, the analytical results from size exclusion chromatography, dynamic light scattering, and micro-flow imaging obtained after the individual measurement time points up to 8 days were compared with those obtained at D0 and with those obtained for unopened vials stored under the same conditions.ResultsNo aggregation or ongoing fragmentation due to partial withdrawal of filling volume could be observed in the residual PF-06439535 solution. Moreover, no changes in the particle size distribution at D8 compared with the D0 values were identified upon storage at either 2–8°C or 25°C (both opened and unopened vials). The total concentration of particles ≥10 µm of all samples was <100 particles/mL. In addition, no variations in the pH values or in the visual appearance were detected over the whole study period in all samples at all storage conditions.ConclusionsConsequently, residual PF-06439535 solution (25 mg/mL) in opened vials may be regarded as stable when stored light-protected over a period of 8 days in the refrigerator (2–8°C) or at 25°C.</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>35853692</pmid><doi>10.1136/ejhpharm-2021-003198</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Biological products Caustic soda Chromatography CLINICAL MEDICINE Drug Monitoring Light MEDICAL ONCOLOGY Molecular weight Monoclonal antibodies OPHTHALMOLOGY Original Research Particle size Patient safety PHARMACEUTICAL PREPARATIONS Vascular endothelial growth factor |
| title | Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials |
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