High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products

Excipients are critical components of a biotherapeutic product as they have a direct impact on the product's stability and hence on its safety and efficacy. A typical biotherapeutic drug product has a variety of excipients and these need to be maintained within very tight specifications in orde...
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Autor*in:	Hebbi, Vishwanath [verfasserIn] Chattopadhyay, Soumili [verfasserIn] Rathore, Anurag S. [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Schlagwörter:	Excipient Ion exclusion chromatography Ion pairing chromatography Monoclonal antibodies

Übergeordnetes Werk:	Enthalten in: Journal of chromatography / B - New York, NY [u.a.] : Science Direct, 1977, 1117, Seite 118-126
Übergeordnetes Werk:	volume:1117 ; pages:118-126

DOI / URN:	10.1016/j.jchromb.2019.04.022

Katalog-ID:	ELV002156415

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245	1	0	\|a High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products
264		1	\|c 2019
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520			\|a Excipients are critical components of a biotherapeutic product as they have a direct impact on the product's stability and hence on its safety and efficacy. A typical biotherapeutic drug product has a variety of excipients and these need to be maintained within very tight specifications in order to ensure consistency in product quality. Hence, there is always a need for estimation of excipient concentration in the drug product. Deviations can occur during formulation process either due to inaccurate buffer preparation or during ultrafiltration/diafiltration of high protein concentration solutions. This paper reports on development of two high performance liquid chromatography (HPLC) based methods for direct and simultaneous estimation of excipients in biopharmaceutical products. Both the methods are modified such that protein is retained in the guard column resulted in clear separation of excipients without any baseline drifts. Ion exclusion chromatography (IEC) and ion pairing chromatography (IPC) have been successfully optimized for analysing 17 commonly used excipients. Operating conditions such as temperature, type of ion pairing agent, and mobile phase strength have been optimized. The proposed methods have been successfully validated as per regulatory guidelines with respect to linearity, accuracy, matrix interference, precision, limit of detection (LOD), and limit of quantification (LOQ). The methods have been successfully used for analysing excipients in a variety of biotherapeutics including insulin, granulocyte colony stimulating factor, rituximab, and ranibizumab. Further, utility of the proposed methods for process development has been demonstrated for designing an ultrafiltration/diafiltration process for one of the mAb products.
650		4	\|a Excipient
650		4	\|a Ion exclusion chromatography
650		4	\|a Ion pairing chromatography
650		4	\|a Monoclonal antibodies
700	1		\|a Chattopadhyay, Soumili \|e verfasserin \|4 aut
700	1		\|a Rathore, Anurag S. \|e verfasserin \|4 aut
773	0	8	\|i Enthalten in \|t Journal of chromatography / B \|d New York, NY [u.a.] : Science Direct, 1977 \|g 1117, Seite 118-126 \|h Online-Ressource \|w (DE-627)302467505 \|w (DE-600)1491259-4 \|w (DE-576)094950261 \|x 1873-376X \|7 nnns
773	1	8	\|g volume:1117 \|g pages:118-126
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912			\|a GBV_ILN_32
912			\|a GBV_ILN_40
912			\|a GBV_ILN_60
912			\|a GBV_ILN_62
912			\|a GBV_ILN_63
912			\|a GBV_ILN_65
912			\|a GBV_ILN_69
912			\|a GBV_ILN_70
912			\|a GBV_ILN_73
912			\|a GBV_ILN_74
912			\|a GBV_ILN_90
912			\|a GBV_ILN_95
912			\|a GBV_ILN_100
912			\|a GBV_ILN_101
912			\|a GBV_ILN_105
912			\|a GBV_ILN_110
912			\|a GBV_ILN_150
912			\|a GBV_ILN_151
912			\|a GBV_ILN_165
912			\|a GBV_ILN_224
912			\|a GBV_ILN_370
912			\|a GBV_ILN_602
912			\|a GBV_ILN_702
912			\|a GBV_ILN_2003
912			\|a GBV_ILN_2004
912			\|a GBV_ILN_2005
912			\|a GBV_ILN_2011
912			\|a GBV_ILN_2014
912			\|a GBV_ILN_2015
912			\|a GBV_ILN_2020
912			\|a GBV_ILN_2021
912			\|a GBV_ILN_2025
912			\|a GBV_ILN_2027
912			\|a GBV_ILN_2034
912			\|a GBV_ILN_2038
912			\|a GBV_ILN_2044
912			\|a GBV_ILN_2048
912			\|a GBV_ILN_2049
912			\|a GBV_ILN_2050
912			\|a GBV_ILN_2056
912			\|a GBV_ILN_2059
912			\|a GBV_ILN_2061
912			\|a GBV_ILN_2064
912			\|a GBV_ILN_2065
912			\|a GBV_ILN_2068
912			\|a GBV_ILN_2111
912			\|a GBV_ILN_2112
912			\|a GBV_ILN_2113
912			\|a GBV_ILN_2118
912			\|a GBV_ILN_2122
912			\|a GBV_ILN_2129
912			\|a GBV_ILN_2143
912			\|a GBV_ILN_2147
912			\|a GBV_ILN_2148
912			\|a GBV_ILN_2152
912			\|a GBV_ILN_2153
912			\|a GBV_ILN_2190
912			\|a GBV_ILN_2336
912			\|a GBV_ILN_2360
912			\|a GBV_ILN_2507
912			\|a GBV_ILN_2522
912			\|a GBV_ILN_4035
912			\|a GBV_ILN_4037
912			\|a GBV_ILN_4112
912			\|a GBV_ILN_4125
912			\|a GBV_ILN_4126
912			\|a GBV_ILN_4242
912			\|a GBV_ILN_4251
912			\|a GBV_ILN_4305
912			\|a GBV_ILN_4313
912			\|a GBV_ILN_4323
912			\|a GBV_ILN_4324
912			\|a GBV_ILN_4325
912			\|a GBV_ILN_4326
912			\|a GBV_ILN_4333
912			\|a GBV_ILN_4334
912			\|a GBV_ILN_4335
912			\|a GBV_ILN_4338
912			\|a GBV_ILN_4393
936	b	k	\|a 35.29 \|j Chromatographische Analyse \|j Elektrophorese
936	b	k	\|a 44.46 \|j Klinische Pathologie
951			\|a AR
952			\|d 1117 \|h 118-126

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matchkey_str	article:1873376X:2019----::ihefraclqicrmtgahhlbsdietnsmlaeuetmtooecpe
hierarchy_sort_str	2019
bklnumber	35.29 44.46
publishDate	2019
allfields	10.1016/j.jchromb.2019.04.022 doi (DE-627)ELV002156415 (ELSEVIER)S1570-0232(19)30241-7 DE-627 ger DE-627 rda eng 540 DE-600 35.29 bkl 44.46 bkl Hebbi, Vishwanath verfasserin aut High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products 2019 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Excipients are critical components of a biotherapeutic product as they have a direct impact on the product's stability and hence on its safety and efficacy. A typical biotherapeutic drug product has a variety of excipients and these need to be maintained within very tight specifications in order to ensure consistency in product quality. Hence, there is always a need for estimation of excipient concentration in the drug product. Deviations can occur during formulation process either due to inaccurate buffer preparation or during ultrafiltration/diafiltration of high protein concentration solutions. This paper reports on development of two high performance liquid chromatography (HPLC) based methods for direct and simultaneous estimation of excipients in biopharmaceutical products. Both the methods are modified such that protein is retained in the guard column resulted in clear separation of excipients without any baseline drifts. Ion exclusion chromatography (IEC) and ion pairing chromatography (IPC) have been successfully optimized for analysing 17 commonly used excipients. Operating conditions such as temperature, type of ion pairing agent, and mobile phase strength have been optimized. The proposed methods have been successfully validated as per regulatory guidelines with respect to linearity, accuracy, matrix interference, precision, limit of detection (LOD), and limit of quantification (LOQ). The methods have been successfully used for analysing excipients in a variety of biotherapeutics including insulin, granulocyte colony stimulating factor, rituximab, and ranibizumab. Further, utility of the proposed methods for process development has been demonstrated for designing an ultrafiltration/diafiltration process for one of the mAb products. Excipient Ion exclusion chromatography Ion pairing chromatography Monoclonal antibodies Chattopadhyay, Soumili verfasserin aut Rathore, Anurag S. verfasserin aut Enthalten in Journal of chromatography / B New York, NY [u.a.] : Science Direct, 1977 1117, Seite 118-126 Online-Ressource (DE-627)302467505 (DE-600)1491259-4 (DE-576)094950261 1873-376X nnns volume:1117 pages:118-126 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_150 GBV_ILN_151 GBV_ILN_165 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2360 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 35.29 Chromatographische Analyse Elektrophorese 44.46 Klinische Pathologie AR 1117 118-126
spelling	10.1016/j.jchromb.2019.04.022 doi (DE-627)ELV002156415 (ELSEVIER)S1570-0232(19)30241-7 DE-627 ger DE-627 rda eng 540 DE-600 35.29 bkl 44.46 bkl Hebbi, Vishwanath verfasserin aut High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products 2019 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Excipients are critical components of a biotherapeutic product as they have a direct impact on the product's stability and hence on its safety and efficacy. A typical biotherapeutic drug product has a variety of excipients and these need to be maintained within very tight specifications in order to ensure consistency in product quality. Hence, there is always a need for estimation of excipient concentration in the drug product. Deviations can occur during formulation process either due to inaccurate buffer preparation or during ultrafiltration/diafiltration of high protein concentration solutions. This paper reports on development of two high performance liquid chromatography (HPLC) based methods for direct and simultaneous estimation of excipients in biopharmaceutical products. Both the methods are modified such that protein is retained in the guard column resulted in clear separation of excipients without any baseline drifts. Ion exclusion chromatography (IEC) and ion pairing chromatography (IPC) have been successfully optimized for analysing 17 commonly used excipients. Operating conditions such as temperature, type of ion pairing agent, and mobile phase strength have been optimized. The proposed methods have been successfully validated as per regulatory guidelines with respect to linearity, accuracy, matrix interference, precision, limit of detection (LOD), and limit of quantification (LOQ). The methods have been successfully used for analysing excipients in a variety of biotherapeutics including insulin, granulocyte colony stimulating factor, rituximab, and ranibizumab. Further, utility of the proposed methods for process development has been demonstrated for designing an ultrafiltration/diafiltration process for one of the mAb products. Excipient Ion exclusion chromatography Ion pairing chromatography Monoclonal antibodies Chattopadhyay, Soumili verfasserin aut Rathore, Anurag S. verfasserin aut Enthalten in Journal of chromatography / B New York, NY [u.a.] : Science Direct, 1977 1117, Seite 118-126 Online-Ressource (DE-627)302467505 (DE-600)1491259-4 (DE-576)094950261 1873-376X nnns volume:1117 pages:118-126 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_150 GBV_ILN_151 GBV_ILN_165 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2360 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 35.29 Chromatographische Analyse Elektrophorese 44.46 Klinische Pathologie AR 1117 118-126
allfields_unstemmed	10.1016/j.jchromb.2019.04.022 doi (DE-627)ELV002156415 (ELSEVIER)S1570-0232(19)30241-7 DE-627 ger DE-627 rda eng 540 DE-600 35.29 bkl 44.46 bkl Hebbi, Vishwanath verfasserin aut High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products 2019 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Excipients are critical components of a biotherapeutic product as they have a direct impact on the product's stability and hence on its safety and efficacy. A typical biotherapeutic drug product has a variety of excipients and these need to be maintained within very tight specifications in order to ensure consistency in product quality. Hence, there is always a need for estimation of excipient concentration in the drug product. Deviations can occur during formulation process either due to inaccurate buffer preparation or during ultrafiltration/diafiltration of high protein concentration solutions. This paper reports on development of two high performance liquid chromatography (HPLC) based methods for direct and simultaneous estimation of excipients in biopharmaceutical products. Both the methods are modified such that protein is retained in the guard column resulted in clear separation of excipients without any baseline drifts. Ion exclusion chromatography (IEC) and ion pairing chromatography (IPC) have been successfully optimized for analysing 17 commonly used excipients. Operating conditions such as temperature, type of ion pairing agent, and mobile phase strength have been optimized. The proposed methods have been successfully validated as per regulatory guidelines with respect to linearity, accuracy, matrix interference, precision, limit of detection (LOD), and limit of quantification (LOQ). The methods have been successfully used for analysing excipients in a variety of biotherapeutics including insulin, granulocyte colony stimulating factor, rituximab, and ranibizumab. Further, utility of the proposed methods for process development has been demonstrated for designing an ultrafiltration/diafiltration process for one of the mAb products. Excipient Ion exclusion chromatography Ion pairing chromatography Monoclonal antibodies Chattopadhyay, Soumili verfasserin aut Rathore, Anurag S. verfasserin aut Enthalten in Journal of chromatography / B New York, NY [u.a.] : Science Direct, 1977 1117, Seite 118-126 Online-Ressource (DE-627)302467505 (DE-600)1491259-4 (DE-576)094950261 1873-376X nnns volume:1117 pages:118-126 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_150 GBV_ILN_151 GBV_ILN_165 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2360 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 35.29 Chromatographische Analyse Elektrophorese 44.46 Klinische Pathologie AR 1117 118-126
allfieldsGer	10.1016/j.jchromb.2019.04.022 doi (DE-627)ELV002156415 (ELSEVIER)S1570-0232(19)30241-7 DE-627 ger DE-627 rda eng 540 DE-600 35.29 bkl 44.46 bkl Hebbi, Vishwanath verfasserin aut High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products 2019 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Excipients are critical components of a biotherapeutic product as they have a direct impact on the product's stability and hence on its safety and efficacy. A typical biotherapeutic drug product has a variety of excipients and these need to be maintained within very tight specifications in order to ensure consistency in product quality. Hence, there is always a need for estimation of excipient concentration in the drug product. Deviations can occur during formulation process either due to inaccurate buffer preparation or during ultrafiltration/diafiltration of high protein concentration solutions. This paper reports on development of two high performance liquid chromatography (HPLC) based methods for direct and simultaneous estimation of excipients in biopharmaceutical products. Both the methods are modified such that protein is retained in the guard column resulted in clear separation of excipients without any baseline drifts. Ion exclusion chromatography (IEC) and ion pairing chromatography (IPC) have been successfully optimized for analysing 17 commonly used excipients. Operating conditions such as temperature, type of ion pairing agent, and mobile phase strength have been optimized. The proposed methods have been successfully validated as per regulatory guidelines with respect to linearity, accuracy, matrix interference, precision, limit of detection (LOD), and limit of quantification (LOQ). The methods have been successfully used for analysing excipients in a variety of biotherapeutics including insulin, granulocyte colony stimulating factor, rituximab, and ranibizumab. Further, utility of the proposed methods for process development has been demonstrated for designing an ultrafiltration/diafiltration process for one of the mAb products. Excipient Ion exclusion chromatography Ion pairing chromatography Monoclonal antibodies Chattopadhyay, Soumili verfasserin aut Rathore, Anurag S. verfasserin aut Enthalten in Journal of chromatography / B New York, NY [u.a.] : Science Direct, 1977 1117, Seite 118-126 Online-Ressource (DE-627)302467505 (DE-600)1491259-4 (DE-576)094950261 1873-376X nnns volume:1117 pages:118-126 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_150 GBV_ILN_151 GBV_ILN_165 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2360 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 35.29 Chromatographische Analyse Elektrophorese 44.46 Klinische Pathologie AR 1117 118-126
allfieldsSound	10.1016/j.jchromb.2019.04.022 doi (DE-627)ELV002156415 (ELSEVIER)S1570-0232(19)30241-7 DE-627 ger DE-627 rda eng 540 DE-600 35.29 bkl 44.46 bkl Hebbi, Vishwanath verfasserin aut High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products 2019 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Excipients are critical components of a biotherapeutic product as they have a direct impact on the product's stability and hence on its safety and efficacy. A typical biotherapeutic drug product has a variety of excipients and these need to be maintained within very tight specifications in order to ensure consistency in product quality. Hence, there is always a need for estimation of excipient concentration in the drug product. Deviations can occur during formulation process either due to inaccurate buffer preparation or during ultrafiltration/diafiltration of high protein concentration solutions. This paper reports on development of two high performance liquid chromatography (HPLC) based methods for direct and simultaneous estimation of excipients in biopharmaceutical products. Both the methods are modified such that protein is retained in the guard column resulted in clear separation of excipients without any baseline drifts. Ion exclusion chromatography (IEC) and ion pairing chromatography (IPC) have been successfully optimized for analysing 17 commonly used excipients. Operating conditions such as temperature, type of ion pairing agent, and mobile phase strength have been optimized. The proposed methods have been successfully validated as per regulatory guidelines with respect to linearity, accuracy, matrix interference, precision, limit of detection (LOD), and limit of quantification (LOQ). The methods have been successfully used for analysing excipients in a variety of biotherapeutics including insulin, granulocyte colony stimulating factor, rituximab, and ranibizumab. Further, utility of the proposed methods for process development has been demonstrated for designing an ultrafiltration/diafiltration process for one of the mAb products. Excipient Ion exclusion chromatography Ion pairing chromatography Monoclonal antibodies Chattopadhyay, Soumili verfasserin aut Rathore, Anurag S. verfasserin aut Enthalten in Journal of chromatography / B New York, NY [u.a.] : Science Direct, 1977 1117, Seite 118-126 Online-Ressource (DE-627)302467505 (DE-600)1491259-4 (DE-576)094950261 1873-376X nnns volume:1117 pages:118-126 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_150 GBV_ILN_151 GBV_ILN_165 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2360 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 35.29 Chromatographische Analyse Elektrophorese 44.46 Klinische Pathologie AR 1117 118-126
language	English
source	Enthalten in Journal of chromatography / B 1117, Seite 118-126 volume:1117 pages:118-126
sourceStr	Enthalten in Journal of chromatography / B 1117, Seite 118-126 volume:1117 pages:118-126
format_phy_str_mv	Article
bklname	Chromatographische Analyse Elektrophorese Klinische Pathologie
institution	findex.gbv.de
topic_facet	Excipient Ion exclusion chromatography Ion pairing chromatography Monoclonal antibodies
dewey-raw	540
isfreeaccess_bool	false
container_title	Journal of chromatography / B
authorswithroles_txt_mv	Hebbi, Vishwanath @@aut@@ Chattopadhyay, Soumili @@aut@@ Rathore, Anurag S. @@aut@@
publishDateDaySort_date	2019-01-01T00:00:00Z
hierarchy_top_id	302467505
dewey-sort	3540
id	ELV002156415
language_de	englisch
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author	Hebbi, Vishwanath
spellingShingle	Hebbi, Vishwanath ddc 540 bkl 35.29 bkl 44.46 misc Excipient misc Ion exclusion chromatography misc Ion pairing chromatography misc Monoclonal antibodies High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products
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topic_title	540 DE-600 35.29 bkl 44.46 bkl High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products Excipient Ion exclusion chromatography Ion pairing chromatography Monoclonal antibodies
topic	ddc 540 bkl 35.29 bkl 44.46 misc Excipient misc Ion exclusion chromatography misc Ion pairing chromatography misc Monoclonal antibodies
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title	High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products
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title_full	High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products
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title_sort	high performance liquid chromatography (hplc) based direct and simultaneous estimation of excipients in biopharmaceutical products
title_auth	High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products
abstract	Excipients are critical components of a biotherapeutic product as they have a direct impact on the product's stability and hence on its safety and efficacy. A typical biotherapeutic drug product has a variety of excipients and these need to be maintained within very tight specifications in order to ensure consistency in product quality. Hence, there is always a need for estimation of excipient concentration in the drug product. Deviations can occur during formulation process either due to inaccurate buffer preparation or during ultrafiltration/diafiltration of high protein concentration solutions. This paper reports on development of two high performance liquid chromatography (HPLC) based methods for direct and simultaneous estimation of excipients in biopharmaceutical products. Both the methods are modified such that protein is retained in the guard column resulted in clear separation of excipients without any baseline drifts. Ion exclusion chromatography (IEC) and ion pairing chromatography (IPC) have been successfully optimized for analysing 17 commonly used excipients. Operating conditions such as temperature, type of ion pairing agent, and mobile phase strength have been optimized. The proposed methods have been successfully validated as per regulatory guidelines with respect to linearity, accuracy, matrix interference, precision, limit of detection (LOD), and limit of quantification (LOQ). The methods have been successfully used for analysing excipients in a variety of biotherapeutics including insulin, granulocyte colony stimulating factor, rituximab, and ranibizumab. Further, utility of the proposed methods for process development has been demonstrated for designing an ultrafiltration/diafiltration process for one of the mAb products.
abstractGer	Excipients are critical components of a biotherapeutic product as they have a direct impact on the product's stability and hence on its safety and efficacy. A typical biotherapeutic drug product has a variety of excipients and these need to be maintained within very tight specifications in order to ensure consistency in product quality. Hence, there is always a need for estimation of excipient concentration in the drug product. Deviations can occur during formulation process either due to inaccurate buffer preparation or during ultrafiltration/diafiltration of high protein concentration solutions. This paper reports on development of two high performance liquid chromatography (HPLC) based methods for direct and simultaneous estimation of excipients in biopharmaceutical products. Both the methods are modified such that protein is retained in the guard column resulted in clear separation of excipients without any baseline drifts. Ion exclusion chromatography (IEC) and ion pairing chromatography (IPC) have been successfully optimized for analysing 17 commonly used excipients. Operating conditions such as temperature, type of ion pairing agent, and mobile phase strength have been optimized. The proposed methods have been successfully validated as per regulatory guidelines with respect to linearity, accuracy, matrix interference, precision, limit of detection (LOD), and limit of quantification (LOQ). The methods have been successfully used for analysing excipients in a variety of biotherapeutics including insulin, granulocyte colony stimulating factor, rituximab, and ranibizumab. Further, utility of the proposed methods for process development has been demonstrated for designing an ultrafiltration/diafiltration process for one of the mAb products.
abstract_unstemmed	Excipients are critical components of a biotherapeutic product as they have a direct impact on the product's stability and hence on its safety and efficacy. A typical biotherapeutic drug product has a variety of excipients and these need to be maintained within very tight specifications in order to ensure consistency in product quality. Hence, there is always a need for estimation of excipient concentration in the drug product. Deviations can occur during formulation process either due to inaccurate buffer preparation or during ultrafiltration/diafiltration of high protein concentration solutions. This paper reports on development of two high performance liquid chromatography (HPLC) based methods for direct and simultaneous estimation of excipients in biopharmaceutical products. Both the methods are modified such that protein is retained in the guard column resulted in clear separation of excipients without any baseline drifts. Ion exclusion chromatography (IEC) and ion pairing chromatography (IPC) have been successfully optimized for analysing 17 commonly used excipients. Operating conditions such as temperature, type of ion pairing agent, and mobile phase strength have been optimized. The proposed methods have been successfully validated as per regulatory guidelines with respect to linearity, accuracy, matrix interference, precision, limit of detection (LOD), and limit of quantification (LOQ). The methods have been successfully used for analysing excipients in a variety of biotherapeutics including insulin, granulocyte colony stimulating factor, rituximab, and ranibizumab. Further, utility of the proposed methods for process development has been demonstrated for designing an ultrafiltration/diafiltration process for one of the mAb products.
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title_short	High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products
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up_date	2024-07-06T23:48:07.050Z
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High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products

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