74. EMA (1997) CPMP position statement on
DNAa nd host cell proteins (HCP) impurities,
routine testing versus validation studies
75. Champion K, Madden H, Dougherty J et al
(2005) Defining your product profile and
maintaining control over it, part 2: challenges
of monitoring host cell protein impurities
76. Wright JF (2014) Product-related impurities
in clinical-grade recombinant AAV vectors:
characterization and risk assessment. Biomedicine 2(1):80–97. https://doi.org/10.3390/
biomedicines2010080
77. Kramberger P, Urbas L, S ˇ trancar A (2015)
Downstream processing and chromatography
based analytical methods for production of
vaccines, gene therapy vectors, and bacteriophages. Hum Vaccin Immunother 11
(4):1010–1021. https://doi.org/10.1080/
21645515.2015.1009817
78. FDA (2018) Chemistry, Manufacturing, and
Control (CMC) information for human gene
therapy Investigational New Drug Applications (INDs): Draft Guidance for Industry
79. Rolda ˜o A, Vicente T, Peixoto C et al (2011)
Quality control and analytical methods for
baculovirus-based products. J Invertebr
Pathol 107(Suppl):S94–S105. https://doi.
org/10.1016/j.jip.2011.05.009
80. Zitzmann J, Sprick G, Weidner T et al (2017)
Process optimization for recombinant protein
expression in insect cells. In: Gowder SJT
(ed) New insights into cell culture technology.
InTechOpen, Rijeka, Croatia
81. Hoffmann D, Leber J, Loewe D et al (2019)
Purification of new biologicals using
membrane-based processes. In: Basile A,
Charcosset C (eds) Current trends and future
developments on (bio-) membranes: membrane processes in the pharmaceutical and
biotechnological field. Elsevier, Amsterdam,
NL, Oxford/Cambridge, USA, pp 123–150
82. Transfiguracion J, Jorio H, Meghrous J et al
(2007) High yield purification of functional
baculovirus vectors by size exclusion chromatography. J Virol Methods 142(1–2):21–28.
https://doi.org/10.1016/j.jviromet.2007.
01.002
83. Barsoum J (1999) Concentration of recombinant baculovirus by cation-exchange chromatography. Biotechniques 26(5):834–836,
838,
840.
https://doi.org/10.2144/
99265bm07
84. Grein TA, Michalsky R, Vega Lo ´ pez M et al
(2012) Purification of a recombinant baculovirus of Autographa californica M nucleopolyhedrovirus by ion exchange membrane
chromatography. J Virol Methods 183
(2):117–124.
https://doi.org/10.1016/j.
jviromet.2012.03.031
85. Wu C, Soh KY, Wang S (2007) Ion-exchange
membrane chromatography method for rapid
and efficient purification of recombinant
baculovirus and baculovirus gp64 protein.
Hum Gene Ther 18(7):665–672. https://
doi.org/10.1089/hum.2007.020
86. Vicente T, Peixoto C, Alves PM et al (2010)
Modeling electrostatic interactions of baculovirus vectors for ion-exchange process development.
J
Chromatogr
A
1217
(24):3754–3764. https://doi.org/10.1016/
j.chroma.2010.03.059
87. Chen G-Y, Chen C-Y, Chang MD-T et al
(2009) Concanavalin A affinity chromatography for efficient baculovirus purification. Biotechnol Prog 25(6):1669–1677. https://doi.
org/10.1002/btpr.253
88. Nasimuzzaman M, Lynn D, van der Loo JC
et al (2016) Purification of baculovirus vectors using heparin affinity chromatography.
Mol Ther Methods Clin Dev 3:16071.
https://doi.org/10.1038/mtm.2016.71
89. Nasimuzzaman M, van der Loo JCM, Malik P
(2018) Production and purification of baculovirus for gene therapy application. J Vis Exp
(134):57019.
https://doi.org/10.3791/
57019
90. Kaikkonen MU, Viholainen JI, N€ arv€ anen A
et al (2008) Targeting and purification of
metabolically biotinylated baculovirus. Hum
Gene Ther 19(6):589–600. https://doi.org/
10.1089/hum.2007.177
91. Lothert K, Sprick G, Beyer F et al (2020)
Membrane-based steric exclusion chromatography for the purification of a recombinant
baculovirus and its application for cell therapy.
J Virol Methods 275:113756. https://doi.
org/10.1016/j.jviromet.2019.113756
92. Michalsky R, Passarelli AL, Pfromm PH et al
(2009) Purification of the baculovirus Autographa californica M nucleopolyhedrovirus
by tangential flow ultrafiltration. Desalination
245(1–3):694–700.
https://doi.org/10.
1016/j.desal.2009.02.039
93. Michalsky R, Passarelli AL, Pfromm PH et al
(2010) Concentration of the baculovirus
Autographa californica M nucleopolyhedrovirus (AcMNPV) by ultrafiltration. Desalination 250(3):1125–1127. https://doi.org/10.
1016/j.desal.2009.09.123
94. Nestola P, Peixoto C, Silva RRJS et al (2015)
Improved virus purification processes for vaccines and gene therapy. Biotechnol Bioeng
112(5):843–857. https://doi.org/10.1002/
bit.25545
Baculovirus-Mediated Gene Transfer to Stem Cells
389
DNAa nd host cell proteins (HCP) impurities,
routine testing versus validation studies
75. Champion K, Madden H, Dougherty J et al
(2005) Defining your product profile and
maintaining control over it, part 2: challenges
of monitoring host cell protein impurities
76. Wright JF (2014) Product-related impurities
in clinical-grade recombinant AAV vectors:
characterization and risk assessment. Biomedicine 2(1):80–97. https://doi.org/10.3390/
biomedicines2010080
77. Kramberger P, Urbas L, S ˇ trancar A (2015)
Downstream processing and chromatography
based analytical methods for production of
vaccines, gene therapy vectors, and bacteriophages. Hum Vaccin Immunother 11
(4):1010–1021. https://doi.org/10.1080/
21645515.2015.1009817
78. FDA (2018) Chemistry, Manufacturing, and
Control (CMC) information for human gene
therapy Investigational New Drug Applications (INDs): Draft Guidance for Industry
79. Rolda ˜o A, Vicente T, Peixoto C et al (2011)
Quality control and analytical methods for
baculovirus-based products. J Invertebr
Pathol 107(Suppl):S94–S105. https://doi.
org/10.1016/j.jip.2011.05.009
80. Zitzmann J, Sprick G, Weidner T et al (2017)
Process optimization for recombinant protein
expression in insect cells. In: Gowder SJT
(ed) New insights into cell culture technology.
InTechOpen, Rijeka, Croatia
81. Hoffmann D, Leber J, Loewe D et al (2019)
Purification of new biologicals using
membrane-based processes. In: Basile A,
Charcosset C (eds) Current trends and future
developments on (bio-) membranes: membrane processes in the pharmaceutical and
biotechnological field. Elsevier, Amsterdam,
NL, Oxford/Cambridge, USA, pp 123–150
82. Transfiguracion J, Jorio H, Meghrous J et al
(2007) High yield purification of functional
baculovirus vectors by size exclusion chromatography. J Virol Methods 142(1–2):21–28.
https://doi.org/10.1016/j.jviromet.2007.
01.002
83. Barsoum J (1999) Concentration of recombinant baculovirus by cation-exchange chromatography. Biotechniques 26(5):834–836,
838,
840.
https://doi.org/10.2144/
99265bm07
84. Grein TA, Michalsky R, Vega Lo ´ pez M et al
(2012) Purification of a recombinant baculovirus of Autographa californica M nucleopolyhedrovirus by ion exchange membrane
chromatography. J Virol Methods 183
(2):117–124.
https://doi.org/10.1016/j.
jviromet.2012.03.031
85. Wu C, Soh KY, Wang S (2007) Ion-exchange
membrane chromatography method for rapid
and efficient purification of recombinant
baculovirus and baculovirus gp64 protein.
Hum Gene Ther 18(7):665–672. https://
doi.org/10.1089/hum.2007.020
86. Vicente T, Peixoto C, Alves PM et al (2010)
Modeling electrostatic interactions of baculovirus vectors for ion-exchange process development.
J
Chromatogr
A
1217
(24):3754–3764. https://doi.org/10.1016/
j.chroma.2010.03.059
87. Chen G-Y, Chen C-Y, Chang MD-T et al
(2009) Concanavalin A affinity chromatography for efficient baculovirus purification. Biotechnol Prog 25(6):1669–1677. https://doi.
org/10.1002/btpr.253
88. Nasimuzzaman M, Lynn D, van der Loo JC
et al (2016) Purification of baculovirus vectors using heparin affinity chromatography.
Mol Ther Methods Clin Dev 3:16071.
https://doi.org/10.1038/mtm.2016.71
89. Nasimuzzaman M, van der Loo JCM, Malik P
(2018) Production and purification of baculovirus for gene therapy application. J Vis Exp
(134):57019.
https://doi.org/10.3791/
57019
90. Kaikkonen MU, Viholainen JI, N€ arv€ anen A
et al (2008) Targeting and purification of
metabolically biotinylated baculovirus. Hum
Gene Ther 19(6):589–600. https://doi.org/
10.1089/hum.2007.177
91. Lothert K, Sprick G, Beyer F et al (2020)
Membrane-based steric exclusion chromatography for the purification of a recombinant
baculovirus and its application for cell therapy.
J Virol Methods 275:113756. https://doi.
org/10.1016/j.jviromet.2019.113756
92. Michalsky R, Passarelli AL, Pfromm PH et al
(2009) Purification of the baculovirus Autographa californica M nucleopolyhedrovirus
by tangential flow ultrafiltration. Desalination
245(1–3):694–700.
https://doi.org/10.
1016/j.desal.2009.02.039
93. Michalsky R, Passarelli AL, Pfromm PH et al
(2010) Concentration of the baculovirus
Autographa californica M nucleopolyhedrovirus (AcMNPV) by ultrafiltration. Desalination 250(3):1125–1127. https://doi.org/10.
1016/j.desal.2009.09.123
94. Nestola P, Peixoto C, Silva RRJS et al (2015)
Improved virus purification processes for vaccines and gene therapy. Biotechnol Bioeng
112(5):843–857. https://doi.org/10.1002/
bit.25545
Baculovirus-Mediated Gene Transfer to Stem Cells
389