Copyright 2012 ATMI, Inc. All Rights Reserved. Copyright 2012 ATMI, Inc. All Rights Reserved. Fabien Moncaubeig Sr Application Specialist & Cell Culture Lab Associate Workshop: Industrialization of a stem cell process – How to identify the right strategy? October 21, 2013 – Bethesda, MD IBC - Cell Therapy Bioprocessing
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Industrialization of a stem cell process - How to identify the right Strategy - IBC Oct 2013
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Copyright 2012 ATMI, Inc. All Rights Reserved. Copyright 2012 ATMI, Inc. All Rights Reserved.
Fabien Moncaubeig
Sr Application Specialist & Cell Culture Lab Associate
Workshop:
Industrialization of a stem cell process – How
to identify the right strategy?
October 21, 2013 – Bethesda, MD
IBC - Cell Therapy Bioprocessing
Copyright 2012 ATMI, Inc. All Rights Reserved.
ATMI Lifesciences where we come from
ATMI LIFESCIENCES
Is part of ATMI Inc, a global company market
leader in efficient process solutions for the semi-
conductor and lifesciences industry
ATMI support leading company in the GMP
manufacturing of vaccines, Mabs and protein
production since 10 years
ATMI is expert in clean manufacturing and supply
of integrated technologies for cell culture
ATMI leverage is core competency in cell culture
to develop innovative technologies and efficient
processes
Copyright 2012 ATMI, Inc. All Rights Reserved.
Our know how
ATMI approach combines both Product
development , Process development & optimization
ATMI has two Applications & Development centers:
Fully equipped cell culture clean rooms.
45 experienced team including Engineers &
Bioengineers
Tech transfer to your facility or to your CMO
PD Services / Support implementation of our technologies
PD for New Bioreactor development
Application & Development Center
Brussels Minneapolis
Surface 500m² 100m²
Classification Class 10,000 (ISO
class 7)
Non-classified
Biosafety level BL-2 BL-2
Copyright 2012 ATMI, Inc. All Rights Reserved.
What we want to offer to the cell therapy
industry
Complete solution for cell based product manufacturing
Offer a full solution for cell growth and harvest, based on the best technologies
availables
Leverage our expertise in cell culture and cell therapy process development to streamline industrialization of cell therapy products
Optimize and enable high volume manufacturing of cell based therapy
Develop the future solutions
Copyright 2012 ATMI, Inc. All Rights Reserved.
Different scale-up and manufacturing challenges for
each segment Autologous
Low dose. cells per patient < 108
High dose. cells per patient > 108
Low # passages possible (Adult SC, chondrocytes, ...)
High # passages possible (hES, iPS,...)
Allogeneic
Patient to Patient variability
Multiple parallel batches
Logisitc
Donor reproducibility
Passage limitations
Targeted lot scale
Downstream and formulation
Copyright 2012 ATMI, Inc. All Rights Reserved.
Your process = Your product
Has never been so true !
Parameters impacting product (cell) quality:
Shear stress 1
2D VS 3D growth 2
Growth Surface Material 3
Changing production platform may require
clinical trial bridging
1: Biotechnol Bioeng. 2007 Feb 15;96(3):584-95. - Effects of shear stress on 3-D human mesenchymal stem cell construct development in a perfusion bioreactor
system: Experiments and hydrodynamic modeling. - Zhao F, Chella R, Ma T.
2: Tissue Eng Part A. 2009 Jul;15(7):1763-73. doi: 10.1089/ten.tea.2008.0306. - Phenotype and gene expression of human mesenchymal stem cells in alginate
scaffolds. - Duggal S, Frønsdal KB, Szöke K, Shahdadfar A, Melvik JE, Brinchmann JE.
3: Acta Biomater. 2013 Feb 26. pii: S1742-7061(13)00105-0. doi: 10.1016/j.actbio.2013.02.035. - Why the dish makes a difference: Quantitative comparison of