Automated, serum-free production of CTX0E03: a therapeutic clinical grade human neural stem cell line

被引：32

作者：

Thomas, R. J. ^{[1
,1
]}

Hope, A. D. ^{[2
]}

Hourd, P. ^{[1
]}

Baradez, M. ^{[2
]}

Miljan, E. A. ^{[2
]}

Sinden, J. D. ^{[2
]}

Williams, D. J. ^{[1
]}

机构：

[1] Univ Loughborough, Wolfson Sch Mech & Mfg Engn, Healthcare Engn Grp, Loughborough LE11 3TU, Leics, England

[2] ReNeuron Ltd, Surrey GU2 7AF, England

来源：

BIOTECHNOLOGY LETTERS | 2009年 / 31卷 / 08期

基金：

英国工程与自然科学研究理事会;

关键词：

Automation; Bioprocess; Cell; Scalability; Stem; Therapy;

D O I：

10.1007/s10529-009-9989-1

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

Automation of cell culture processes is necessary to achieve scalable and reproducible manufacture of cell-based therapies. CTX0E03 is a near-clinic neural stem cell line for stroke therapy. The transfer of the CTX0E03 manufacture process from a manual to a completely automated process is demonstrated by (a) adapting the manual process to conform to the automated platform and (b) conducted a large scale (20 x T175 flasks) automated CTX0E03 expansion in accordance with the working bank to drug substance lot manufacture schedule. The automated lot was within the GMP release specification for viability, growth rate, nestin immunoreactivity and transcriptome equivalence.

引用

页码：1167 / 1172

页数：6

共 10 条

[1] Why tissue engineering needs process engineering [J].

Archer, R ;

Williams, DJ .

NATURE BIOTECHNOLOGY, 2005, 23 (11) :1353-1355

[2] Automated mechanical passaging:: A novel and efficient method for human embryonic stem cell expansion [J].

Joannides, Alexis ;

Fiore-Heriche, Christelle ;

Westmore, Kristine ;

Caldwell, Maeve ;

Compston, Alastair ;

Allen, Nicholas ;

Chandran, Siddharthan .

STEM CELLS, 2006, 24 (02) :230-235

[3] Great expectations: Private sector activity in tissue engineering, regenerative medicine, and stem cell therapeutics [J].

Lysaght, Michael J. ;

Jaklenec, Ana ;

Deweerd, Elizabeth .

TISSUE ENGINEERING PART A, 2008, 14 (02) :305-U57

[4] Commercial considerations in tissue engineering [J].

Mansbridge, Jonathan .

JOURNAL OF ANATOMY, 2006, 209 (04) :527-532

[5] Regenerative medicine 2.0 [J].

Mason, Chris .

REGENERATIVE MEDICINE, 2007, 2 (01) :11-18

[6] A conditionally immortal clonal. stem cell line from human cortical neuroepithelium for the treatment of ischemic stroke [J].

Pollock, Kenneth ;

Stroemer, Paul ;

Patel, Sara ;

Stevanato, Lara ;

Hope, Andrew ;

Miljan, Erik ;

Dong, Ziping ;

Hodges, Helen ;

Price, Jack ;

Sinden, John D. .

EXPERIMENTAL NEUROLOGY, 2006, 199 (01) :143-155

[7] Automated maintenance of embryonic stem cell cultures [J].

Terstegge, Stefanie ;

Laufenberg, Iris ;

Pochert, Joerg ;

Schenk, Sabine ;

Itskovitz-Eldor, Joseph ;

Endl, Ehnar ;

Bruestle, Oliver .

BIOTECHNOLOGY AND BIOENGINEERING, 2007, 96 (01) :195-201

[8] Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use [J].

Thomas, R. J. ;

Hourd, P. C. ;

Williams, D. J. .

JOURNAL OF BIOTECHNOLOGY, 2008, 136 (3-4) :148-155

[9]

THOMAS RJ, 2008, BIOTECH BIOENG

[10] Accurate normalization of real-time quantitative RT-PCR data by geometric averaging of multiple internal control genes [J].

Vandesompele, Jo ;

De Preter, Katleen ;

Pattyn, Filip ;

Poppe, Bruce ;

Van Roy, Nadine ;

De Paepe, Anne ;

Speleman, Frank .

GENOME BIOLOGY, 2002, 3 (07)

← 1 →