NDLI: Dermagraft/sup /spl reg// scale-up case study

Content Provider	IEEE Xplore Digital Library
Author	Kemmerrer, S.V. Bagley, D.K.
Copyright Year	2002
Description	Author affiliation: Adv. Tissue Sci., CA, USA (Kemmerrer, S.V.)
Abstract	Dermagraft/sup /spl reg// human fibroblast derived dermal substitute is a fibroblast cell based tissue, grown on a bioresorbable three-dimensional scaffold. At time of application, the product contains viable cells that are important for wound healing. Dermagraft/sup /spl reg// was developed primarily for the treatment of diabetic foot ulcers. The product had been developed for early clinical trials as single units. For commercial launch a scaled-up bioreactor and growth system were needed. It was desired that the bioreactor serve as the final package for delivery. Larger lot sizes were targeted at 1000 units. To achieve these goals, a new bioreactor was developed. This required a new concept to allow for multiple units. Bioreactor systems consisting of flexible plastic have been selected for the scale-up of the Dermagraft product. This system has the advantages of being used as the bioreactor for growth as well as the final container supplied to the customer. Additionally, there is no post-growth handling of the product to minimize the risk of contamination. The final product configuration meets all the customer requirements, including ease of usability, handling and application to the wound. It has been demonstrated that product yields in this scaled-up production system are sufficient to make the product commercially viable.
Starting Page	879
Ending Page	880
File Size	141911
Page Count	2
File Format	PDF
ISBN	0780376129
ISSN	1094687X
DOI	10.1109/IEMBS.2002.1137123
Language	English
Publisher	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Publisher Date	2002-10-23
Publisher Place	USA
Access Restriction	Subscribed
Rights Holder	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Subject Keyword	Bioreactors Fibroblasts Wounds Humans Dermis Diabetes Foot Clinical trials Packaging Plastics
Content Type	Text
Resource Type	Article

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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