Long-Term Stability and Differentiation Potential of Cryopreserved cGMP-Compliant Human Induced Pluripotent Stem Cells

Shafa, Mehdi; Walsh, Tylor; Panchalingam, Krishna M.; Richardson, Thomas; Menéndez, Laura; Tian, Xu; Babu, Sahana Suresh; Dadgar, Saedeh; Beller, Justin; Yang, Fan; Baghbaderani, Behnam Ahmadian

doi:10.3390/ijms21010108

Cited by 18 publications

(12 citation statements)

References 33 publications

(35 reference statements)

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“…Other crucial aspects when cell banking is being designed are the cryopreservation and storage conditions. 21,22 HEK293T MCB and WCB were subjected to a cryopreservation ramp of 1 °C/min. Thawed cryovials showed cell viability over 90% indicating that cryopreservation did not affect the quality of the product.…”

Section: Discussionmentioning

confidence: 99%

Cell Banking of HEK293T Cell Line for Clinical-Grade Lentiviral Particles Manufacturing

Perpiñá

Herranz

Martín‐Ibáñez

et al. 2020

Preprint

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Background: Cell banks have been widely used to preserve cell properties as well as to record and control cell line access in research. However, the generation of cell banks involved in the manufacturing of Advanced therapy medicinal products such as cell or gene therapy products must comply with the current Good Manufacturing Practice regulation. Similarly, the quality of those cell lines used as starting materials in viral-vector manufacturing processes must be also evaluated.Methods: Three batches of both Master Cell Bank and Working Cell Bank of the HEK293T cell line were manufactured under the current Good Manufacturing Practices regulation. Quality control test were performed according to the product specifications. The process validation includes previous qualification of the manufacturing personnel by performing simulation tests as well as the continuous measure of environmental parameters during manufacturing such as air particles and microorganism. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products.Results: All batches of Master Cell Bank and Working Cell Bank fulfilled the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working cell bank maintain the defined viability and cell number 37 months after cryopreservation. Conclusions: Manufacturing cell banks under Good Manufacturing Practices regulation for its use as raw material or final cellular product is feasible. HEK293T cell banks have been used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials.

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Section: Discussionmentioning

confidence: 99%

Cell Banking of HEK293T Cell Line for Clinical-Grade Lentiviral Particles Manufacturing

Perpiñá

Herranz

Martín‐Ibáñez

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…Other crucial aspects of cell banking are cryopreservation and storage conditions. 21,22 The cryopreservation of HEK293T MCB and WCB was obtained using a freezing ramp of 1°C/min. Cell viability after thawing was over 90% indicating that cryopreservation procedure did not affect the quality of the product.…”

Section: Discussionmentioning

confidence: 99%

Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing

Perpiñá

Herranz

Martín‐Ibáñez

et al. 2020

Preprint

View full text Add to dashboard Cite

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.

show abstract

“…Other crucial aspects of cell banking are cryopreservation and storage conditions [21,22]. The cryopreservation of HEK293T MCB and WCB was obtained using a freezing ramp of 1°C/min.…”

Section: Discussionmentioning

confidence: 99%

Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing

et al. 2020

View full text Add to dashboard Cite

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.

show abstract

Long-Term Stability and Differentiation Potential of Cryopreserved cGMP-Compliant Human Induced Pluripotent Stem Cells

Cited by 18 publications

References 33 publications

Cell Banking of HEK293T Cell Line for Clinical-Grade Lentiviral Particles Manufacturing

Cell Banking of HEK293T Cell Line for Clinical-Grade Lentiviral Particles Manufacturing

Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing

Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing

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