Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing
Background Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Perpiñá, Unai [verfasserIn] Herranz, Cristina [verfasserIn] Martín-Ibáñez, Raquel [verfasserIn] Boronat, Anna [verfasserIn] Chiappe, Felipe [verfasserIn] Monforte, Verónica [verfasserIn] Orpella-Aceret, Gemma [verfasserIn] González, Ester [verfasserIn] Olivé, Myriam [verfasserIn] Castella, María [verfasserIn] Suñé, Guillermo [verfasserIn] Urbano-Ispizua, Álvaro [verfasserIn] Delgado, Julio [verfasserIn] Juan, Manel [verfasserIn] Canals, Josep M. [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2020 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Translational medicine communications - [London] : BioMed Central, 2016, 5(2020), 1 vom: 19. Nov. |
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| Übergeordnetes Werk: |
volume:5 ; year:2020 ; number:1 ; day:19 ; month:11 |
| Links: |
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| DOI / URN: |
10.1186/s41231-020-00075-w |
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| Katalog-ID: |
SPR042083990 |
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| 024 | 7 | |a 10.1186/s41231-020-00075-w |2 doi | |
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| 100 | 1 | |a Perpiñá, Unai |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing |
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| 520 | |a Background Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials. | ||
| 650 | 4 | |a ATMP |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Good Manufacturing Practices |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Cell therapy |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Gene therapy |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a HEK293T |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a CAR-T |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a lentivirus |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Herranz, Cristina |e verfasserin |4 aut | |
| 700 | 1 | |a Martín-Ibáñez, Raquel |e verfasserin |4 aut | |
| 700 | 1 | |a Boronat, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Chiappe, Felipe |e verfasserin |4 aut | |
| 700 | 1 | |a Monforte, Verónica |e verfasserin |4 aut | |
| 700 | 1 | |a Orpella-Aceret, Gemma |e verfasserin |4 aut | |
| 700 | 1 | |a González, Ester |e verfasserin |4 aut | |
| 700 | 1 | |a Olivé, Myriam |e verfasserin |4 aut | |
| 700 | 1 | |a Castella, María |e verfasserin |4 aut | |
| 700 | 1 | |a Suñé, Guillermo |e verfasserin |4 aut | |
| 700 | 1 | |a Urbano-Ispizua, Álvaro |e verfasserin |4 aut | |
| 700 | 1 | |a Delgado, Julio |e verfasserin |4 aut | |
| 700 | 1 | |a Juan, Manel |e verfasserin |4 aut | |
| 700 | 1 | |a Canals, Josep M. |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Translational medicine communications |d [London] : BioMed Central, 2016 |g 5(2020), 1 vom: 19. Nov. |w (DE-627)866576657 |w (DE-600)2866853-4 |x 2396-832X |7 nnns |
| 773 | 1 | 8 | |g volume:5 |g year:2020 |g number:1 |g day:19 |g month:11 |
| 856 | 4 | 0 | |u https://dx.doi.org/10.1186/s41231-020-00075-w |z kostenfrei |3 Volltext |
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2020 |
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10.1186/s41231-020-00075-w doi (DE-627)SPR042083990 (SPR)s41231-020-00075-w-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE Perpiñá, Unai verfasserin aut Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials. ATMP (dpeaa)DE-He213 Good Manufacturing Practices (dpeaa)DE-He213 Cell therapy (dpeaa)DE-He213 Gene therapy (dpeaa)DE-He213 HEK293T (dpeaa)DE-He213 CAR-T (dpeaa)DE-He213 lentivirus (dpeaa)DE-He213 Herranz, Cristina verfasserin aut Martín-Ibáñez, Raquel verfasserin aut Boronat, Anna verfasserin aut Chiappe, Felipe verfasserin aut Monforte, Verónica verfasserin aut Orpella-Aceret, Gemma verfasserin aut González, Ester verfasserin aut Olivé, Myriam verfasserin aut Castella, María verfasserin aut Suñé, Guillermo verfasserin aut Urbano-Ispizua, Álvaro verfasserin aut Delgado, Julio verfasserin aut Juan, Manel verfasserin aut Canals, Josep M. verfasserin aut Enthalten in Translational medicine communications [London] : BioMed Central, 2016 5(2020), 1 vom: 19. Nov. (DE-627)866576657 (DE-600)2866853-4 2396-832X nnns volume:5 year:2020 number:1 day:19 month:11 https://dx.doi.org/10.1186/s41231-020-00075-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 5 2020 1 19 11 |
| spelling |
10.1186/s41231-020-00075-w doi (DE-627)SPR042083990 (SPR)s41231-020-00075-w-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE Perpiñá, Unai verfasserin aut Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials. ATMP (dpeaa)DE-He213 Good Manufacturing Practices (dpeaa)DE-He213 Cell therapy (dpeaa)DE-He213 Gene therapy (dpeaa)DE-He213 HEK293T (dpeaa)DE-He213 CAR-T (dpeaa)DE-He213 lentivirus (dpeaa)DE-He213 Herranz, Cristina verfasserin aut Martín-Ibáñez, Raquel verfasserin aut Boronat, Anna verfasserin aut Chiappe, Felipe verfasserin aut Monforte, Verónica verfasserin aut Orpella-Aceret, Gemma verfasserin aut González, Ester verfasserin aut Olivé, Myriam verfasserin aut Castella, María verfasserin aut Suñé, Guillermo verfasserin aut Urbano-Ispizua, Álvaro verfasserin aut Delgado, Julio verfasserin aut Juan, Manel verfasserin aut Canals, Josep M. verfasserin aut Enthalten in Translational medicine communications [London] : BioMed Central, 2016 5(2020), 1 vom: 19. Nov. (DE-627)866576657 (DE-600)2866853-4 2396-832X nnns volume:5 year:2020 number:1 day:19 month:11 https://dx.doi.org/10.1186/s41231-020-00075-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 5 2020 1 19 11 |
| allfields_unstemmed |
10.1186/s41231-020-00075-w doi (DE-627)SPR042083990 (SPR)s41231-020-00075-w-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE Perpiñá, Unai verfasserin aut Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials. ATMP (dpeaa)DE-He213 Good Manufacturing Practices (dpeaa)DE-He213 Cell therapy (dpeaa)DE-He213 Gene therapy (dpeaa)DE-He213 HEK293T (dpeaa)DE-He213 CAR-T (dpeaa)DE-He213 lentivirus (dpeaa)DE-He213 Herranz, Cristina verfasserin aut Martín-Ibáñez, Raquel verfasserin aut Boronat, Anna verfasserin aut Chiappe, Felipe verfasserin aut Monforte, Verónica verfasserin aut Orpella-Aceret, Gemma verfasserin aut González, Ester verfasserin aut Olivé, Myriam verfasserin aut Castella, María verfasserin aut Suñé, Guillermo verfasserin aut Urbano-Ispizua, Álvaro verfasserin aut Delgado, Julio verfasserin aut Juan, Manel verfasserin aut Canals, Josep M. verfasserin aut Enthalten in Translational medicine communications [London] : BioMed Central, 2016 5(2020), 1 vom: 19. Nov. (DE-627)866576657 (DE-600)2866853-4 2396-832X nnns volume:5 year:2020 number:1 day:19 month:11 https://dx.doi.org/10.1186/s41231-020-00075-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 5 2020 1 19 11 |
| allfieldsGer |
10.1186/s41231-020-00075-w doi (DE-627)SPR042083990 (SPR)s41231-020-00075-w-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE Perpiñá, Unai verfasserin aut Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials. ATMP (dpeaa)DE-He213 Good Manufacturing Practices (dpeaa)DE-He213 Cell therapy (dpeaa)DE-He213 Gene therapy (dpeaa)DE-He213 HEK293T (dpeaa)DE-He213 CAR-T (dpeaa)DE-He213 lentivirus (dpeaa)DE-He213 Herranz, Cristina verfasserin aut Martín-Ibáñez, Raquel verfasserin aut Boronat, Anna verfasserin aut Chiappe, Felipe verfasserin aut Monforte, Verónica verfasserin aut Orpella-Aceret, Gemma verfasserin aut González, Ester verfasserin aut Olivé, Myriam verfasserin aut Castella, María verfasserin aut Suñé, Guillermo verfasserin aut Urbano-Ispizua, Álvaro verfasserin aut Delgado, Julio verfasserin aut Juan, Manel verfasserin aut Canals, Josep M. verfasserin aut Enthalten in Translational medicine communications [London] : BioMed Central, 2016 5(2020), 1 vom: 19. Nov. (DE-627)866576657 (DE-600)2866853-4 2396-832X nnns volume:5 year:2020 number:1 day:19 month:11 https://dx.doi.org/10.1186/s41231-020-00075-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 5 2020 1 19 11 |
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10.1186/s41231-020-00075-w doi (DE-627)SPR042083990 (SPR)s41231-020-00075-w-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE Perpiñá, Unai verfasserin aut Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials. ATMP (dpeaa)DE-He213 Good Manufacturing Practices (dpeaa)DE-He213 Cell therapy (dpeaa)DE-He213 Gene therapy (dpeaa)DE-He213 HEK293T (dpeaa)DE-He213 CAR-T (dpeaa)DE-He213 lentivirus (dpeaa)DE-He213 Herranz, Cristina verfasserin aut Martín-Ibáñez, Raquel verfasserin aut Boronat, Anna verfasserin aut Chiappe, Felipe verfasserin aut Monforte, Verónica verfasserin aut Orpella-Aceret, Gemma verfasserin aut González, Ester verfasserin aut Olivé, Myriam verfasserin aut Castella, María verfasserin aut Suñé, Guillermo verfasserin aut Urbano-Ispizua, Álvaro verfasserin aut Delgado, Julio verfasserin aut Juan, Manel verfasserin aut Canals, Josep M. verfasserin aut Enthalten in Translational medicine communications [London] : BioMed Central, 2016 5(2020), 1 vom: 19. Nov. (DE-627)866576657 (DE-600)2866853-4 2396-832X nnns volume:5 year:2020 number:1 day:19 month:11 https://dx.doi.org/10.1186/s41231-020-00075-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 5 2020 1 19 11 |
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Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing |
| abstract |
Background Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials. |
| abstractGer |
Background Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials. |
| abstract_unstemmed |
Background Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials. |
| collection_details |
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| container_issue |
1 |
| title_short |
Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing |
| url |
https://dx.doi.org/10.1186/s41231-020-00075-w |
| remote_bool |
true |
| author2 |
Herranz, Cristina Martín-Ibáñez, Raquel Boronat, Anna Chiappe, Felipe Monforte, Verónica Orpella-Aceret, Gemma González, Ester Olivé, Myriam Castella, María Suñé, Guillermo Urbano-Ispizua, Álvaro Delgado, Julio Juan, Manel Canals, Josep M. |
| author2Str |
Herranz, Cristina Martín-Ibáñez, Raquel Boronat, Anna Chiappe, Felipe Monforte, Verónica Orpella-Aceret, Gemma González, Ester Olivé, Myriam Castella, María Suñé, Guillermo Urbano-Ispizua, Álvaro Delgado, Julio Juan, Manel Canals, Josep M. |
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866576657 |
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c |
| isOA_txt |
true |
| hochschulschrift_bool |
false |
| doi_str |
10.1186/s41231-020-00075-w |
| up_date |
2024-07-04T00:45:03.620Z |
| _version_ |
1803607242044342272 |
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The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. 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7.4013157 |