Optimization of a recombinant human growth hormone purification process using quality by design

Carolina Ortiz-Enriquez; Alexis de Jesús Romero-Díaz; Ana V. Hernández-Moreno; Hugo F. Cueto-Rojas; Mariana P. Miranda-Hernández; Carlos A. López-Morales; Néstor O. Pérez; Rodolfo Salazar-Ceballos; Norberto Cruz-García; Luis F. Flores-Ortiz; Emilio Medina-Rivero

doi:10.1080/10826068.2015.1135467

Optimization of a recombinant human growth hormone purification process using quality by design

Carolina Ortiz-Enriquez, Alexis de Jesús Romero-Díaz, Ana V. Hernández-Moreno, Hugo F. Cueto-Rojas, Mariana P. Miranda-Hernández, Carlos A. López-Morales, Néstor O. Pérez, Rodolfo Salazar-Ceballos, Norberto Cruz-García, Luis F. Flores-Ortiz, Emilio Medina-Rivero

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3 Scopus citations

Abstract

This work describes a strategy to optimize a downstream processing of a recombinant human growth hormone (rhGH) by incorporating a quality by design approach toward meeting higher quality specifications. The optimized process minimized the presence of impurities and degradation by-products during manufacturing by the establishment of in-process controls. Capillary zone electrophoresis, reverse phase, and size-exclusion chromatographies were used as analytical techniques to establish new critical process parameters for the solubilization, capture, and intermediate purification steps aiming to maintain rhGH quality by complying with pharmacopeial specifications. The results indicated that the implemented improvements in the process allowed the optimization of the specific recovery and purification of rhGH without compromising its quality. In addition, this optimization facilitated the stringent removal of the remaining impurities in further polishing stages, as demonstrated by the analysis of the obtained active pharmaceutical ingredient.

Original language	English
Pages (from-to)	815-821
Number of pages	7
Journal	Preparative Biochemistry and Biotechnology
Volume	46
Issue number	8
DOIs	https://doi.org/10.1080/10826068.2015.1135467
State	Published - 16 Nov 2016
Externally published	Yes

Keywords

Critical process parameters
critical quality attributes
process optimization
purification process
quality by design
recombinant human growth hormone

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10.1080/10826068.2015.1135467

Cite this

Ortiz-Enriquez, C., Romero-Díaz, A. D. J., Hernández-Moreno, A. V., Cueto-Rojas, H. F., Miranda-Hernández, M. P., López-Morales, C. A., Pérez, N. O., Salazar-Ceballos, R., Cruz-García, N., Flores-Ortiz, L. F., & Medina-Rivero, E. (2016). Optimization of a recombinant human growth hormone purification process using quality by design. Preparative Biochemistry and Biotechnology, 46(8), 815-821. https://doi.org/10.1080/10826068.2015.1135467

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title = "Optimization of a recombinant human growth hormone purification process using quality by design",

abstract = "This work describes a strategy to optimize a downstream processing of a recombinant human growth hormone (rhGH) by incorporating a quality by design approach toward meeting higher quality specifications. The optimized process minimized the presence of impurities and degradation by-products during manufacturing by the establishment of in-process controls. Capillary zone electrophoresis, reverse phase, and size-exclusion chromatographies were used as analytical techniques to establish new critical process parameters for the solubilization, capture, and intermediate purification steps aiming to maintain rhGH quality by complying with pharmacopeial specifications. The results indicated that the implemented improvements in the process allowed the optimization of the specific recovery and purification of rhGH without compromising its quality. In addition, this optimization facilitated the stringent removal of the remaining impurities in further polishing stages, as demonstrated by the analysis of the obtained active pharmaceutical ingredient.",

keywords = "Critical process parameters, critical quality attributes, process optimization, purification process, quality by design, recombinant human growth hormone",

author = "Carolina Ortiz-Enriquez and Romero-D{\'i}az, {Alexis de Jes{\'u}s} and Hern{\'a}ndez-Moreno, {Ana V.} and Cueto-Rojas, {Hugo F.} and Miranda-Hern{\'a}ndez, {Mariana P.} and L{\'o}pez-Morales, {Carlos A.} and P{\'e}rez, {N{\'e}stor O.} and Rodolfo Salazar-Ceballos and Norberto Cruz-Garc{\'i}a and Flores-Ortiz, {Luis F.} and Emilio Medina-Rivero",

note = "Publisher Copyright: {\textcopyright} 2016, Copyright {\textcopyright} Taylor & Francis Group, LLC.",

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doi = "10.1080/10826068.2015.1135467",

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Ortiz-Enriquez, C, Romero-Díaz, ADJ, Hernández-Moreno, AV, Cueto-Rojas, HF, Miranda-Hernández, MP, López-Morales, CA, Pérez, NO, Salazar-Ceballos, R, Cruz-García, N, Flores-Ortiz, LF & Medina-Rivero, E 2016, 'Optimization of a recombinant human growth hormone purification process using quality by design', Preparative Biochemistry and Biotechnology, vol. 46, no. 8, pp. 815-821. https://doi.org/10.1080/10826068.2015.1135467

TY - JOUR

T1 - Optimization of a recombinant human growth hormone purification process using quality by design

AU - Ortiz-Enriquez, Carolina

AU - Romero-Díaz, Alexis de Jesús

AU - Hernández-Moreno, Ana V.

AU - Cueto-Rojas, Hugo F.

AU - Miranda-Hernández, Mariana P.

AU - López-Morales, Carlos A.

AU - Pérez, Néstor O.

AU - Salazar-Ceballos, Rodolfo

AU - Cruz-García, Norberto

AU - Flores-Ortiz, Luis F.

AU - Medina-Rivero, Emilio

PY - 2016/11/16

Y1 - 2016/11/16

N2 - This work describes a strategy to optimize a downstream processing of a recombinant human growth hormone (rhGH) by incorporating a quality by design approach toward meeting higher quality specifications. The optimized process minimized the presence of impurities and degradation by-products during manufacturing by the establishment of in-process controls. Capillary zone electrophoresis, reverse phase, and size-exclusion chromatographies were used as analytical techniques to establish new critical process parameters for the solubilization, capture, and intermediate purification steps aiming to maintain rhGH quality by complying with pharmacopeial specifications. The results indicated that the implemented improvements in the process allowed the optimization of the specific recovery and purification of rhGH without compromising its quality. In addition, this optimization facilitated the stringent removal of the remaining impurities in further polishing stages, as demonstrated by the analysis of the obtained active pharmaceutical ingredient.

AB - This work describes a strategy to optimize a downstream processing of a recombinant human growth hormone (rhGH) by incorporating a quality by design approach toward meeting higher quality specifications. The optimized process minimized the presence of impurities and degradation by-products during manufacturing by the establishment of in-process controls. Capillary zone electrophoresis, reverse phase, and size-exclusion chromatographies were used as analytical techniques to establish new critical process parameters for the solubilization, capture, and intermediate purification steps aiming to maintain rhGH quality by complying with pharmacopeial specifications. The results indicated that the implemented improvements in the process allowed the optimization of the specific recovery and purification of rhGH without compromising its quality. In addition, this optimization facilitated the stringent removal of the remaining impurities in further polishing stages, as demonstrated by the analysis of the obtained active pharmaceutical ingredient.

KW - Critical process parameters

KW - critical quality attributes

KW - process optimization

KW - purification process

KW - quality by design

KW - recombinant human growth hormone

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DO - 10.1080/10826068.2015.1135467

M3 - Artículo

SN - 1082-6068

VL - 46

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EP - 821

JO - Preparative Biochemistry and Biotechnology

JF - Preparative Biochemistry and Biotechnology

IS - 8

ER -

Optimization of a recombinant human growth hormone purification process using quality by design

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Keywords

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