Document Detail

Process quality engineering for bioreactor-driven manufacturing of tissue engineered constructs for bone regeneration.
MedLine Citation:
PMID:  23198999     Owner:  NLM     Status:  Publisher    
The incorporation of Quality by Design (QbD) principles in tissue engineering bioprocess development towards clinical use will ensure that manufactured constructs possess prerequisite quality characteristics addressing emerging regulatory requirements and ensuring functional in-vivo behavior. In this work QbD principles were applied on a manufacturing process step for the in vitro production of osteogenic three-dimensional hybrid scaffolds which involves cell matrix deposition on a three dimensional titanium (Ti) alloy scaffold. An osteogenic cell source (human periosteum derived cells, hPDCs) cultured in a bio-instructive medium was used to functionalise regular Ti-scaffolds in a perfusion bioreactor, resulting in an osteogenic 'hybrid' carrier. A two level three factor fractional factorial design of experiments (DoE) was employed to explore a range of production-relevant process conditions by simultaneously changing value levels of the following parameters: flow rate (0.5-2 mL/min), cell culture duration (7-21 days) and cell seeding density (1.5*103-3*103 cells/cm2). This approach allowed to evaluate the individual impact of the aforementioned process parameters upon key quality attributes of the produced hybrids, such as collagen production, mineralization level and cell number. The use of a fractional factorial design approach helped create a 'design space' in which hybrid scaffolds of predefined quality attributes may be robustly manufactured while minimizing the number of required experiments.
Ioannis Papantoniou; Yoke Chin Chai; Frank Prosper Luyten; Jan Schrooten
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-2
Journal Detail:
Title:  Tissue engineering. Part C, Methods     Volume:  -     ISSN:  1937-3392     ISO Abbreviation:  Tissue Eng Part C Methods     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-3     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101466663     Medline TA:  Tissue Eng Part C Methods     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Katholieke Universiteit Leuven, Laboratory for Skeletal Development and Joint Disorders, Bus 813, O&N 1, Herestraat 49, Leuven, Belgium, 3000, +32 16 346169;
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