Design and operation of a current good manufacturing practices cell-engineering laboratory
Medical centers and biotechnology companies active in cellular and gene therapy increasingly are working to design and build clinical laboratories capable of performing cellular engineering and vector production using current good manufacturing practices (cGMPs). Because cell engineering is a rapidl...
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| Published in | Cytotherapy (Oxford, England) Vol. 2; no. 2; pp. 111 - 122 |
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| Main Author | |
| Format | Journal Article |
| Language | English |
| Published |
England
Elsevier Inc
01.02.2000
Informa UK Ltd |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Medical centers and biotechnology companies active in cellular and gene therapy increasingly are working to design and build clinical laboratories capable of performing cellular engineering and vector production using current good manufacturing practices (cGMPs). Because cell engineering is a rapidly changing field, and definitions for cell engineering cGMPs are still being established, a cGMP cell-engineering laboratory most often should be designed with a broad range of potential applications in mind. While the laboratory facility is the most tangible aspect of cGMP, it represents only part of a larger process, which it must be designed and built to support. |
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| AbstractList | Medical centers and biotechnology companies active in cellular and gene therapy increasingly are working to design and build clinical laboratories capable of performing cellular engineering and vector production using current good manufacturing practices (cGMPs). Because cell engineering is a rapidly changing field, and definitions for cell engineering cGMPs are still being established, a cGMP cell-engineering laboratory most often should be designed with a broad range of potential applications in mind. While the laboratory facility is the most tangible aspect of cGMP, it represents only part of a larger process, which it must be designed and built to support. |
| Author | Burger, Scott R. |
| Author_xml | – sequence: 1 givenname: Scott R. surname: Burger fullname: Burger, Scott R. organization: Cell Therapy Clinical Laboratory, University of Minnesota, Fairview- University Medical Center Minneapolis, MN, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/12042048$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1038/nbt0593-561 10.3109/07853899709007486 10.1046/j.1537-2995.1995.351196110902.x 10.1002/jcb.240580402 |
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| Copyright | 2000 International Society for Cellular Therapy 2000 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted 2000 |
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| References_xml | – volume: 29 start-page: 579 year: 1997 end-page: 583 ident: bib12 article-title: An academiccentre for gene therapy research with clinical grade manufacturing capability publication-title: Ann Med contributor: fullname: Smith – volume: 35 start-page: 955 year: 1995 end-page: 966 ident: bib4 article-title: Current good manufacturing practices publication-title: Transfusion contributor: fullname: Zuck – volume: 1 start-page: 358 year: 1999 end-page: 359 ident: bib2 article-title: FDA's proposed regulatory approach to regulation of hematopoietic stem/progenitor cell products publication-title: Cytotherapy contributor: fullname: Harvath – year: 1991 ident: bib24 article-title: Environmental monitoring: regulatory issues publication-title: Sterile pharmaceutical manufacturing - applications for the 90s contributor: fullname: Sorenson – volume: 11 start-page: 44 year: 1997 end-page: 51 ident: bib5 article-title: Big biotech: designing the plant of the future publication-title: Bio Pharm contributor: fullname: Williams – volume: 51 start-page: 161 year: 1997 end-page: 162 ident: bib19 article-title: Setting alert/action limits for environmentalmonitoring programs publication-title: PDA J Pharm Sci Technol contributor: fullname: Wilson – volume: 91 start-page: 73 year: 1997 end-page: 78 ident: bib20 article-title: In-process testing and limits publication-title: Develop Bio Standard contributor: fullname: Sjoholm – volume: 6 start-page: 42 year: 1993 end-page: 52 ident: bib7 article-title: Building quality into G.M.P. facilities publication-title: BioPharm contributor: fullname: Odum – volume: 11 start-page: 32 year: 1996 end-page: 40 ident: bib11 article-title: Designing an initial gene therapy manufacturing facility publication-title: BioPharm contributor: fullname: Pergolizzi – volume: 61 start-page: 20104 year: 1996 end-page: 20115 ident: bib14 article-title: ProposedAmendment of Certain Requirements for FinishedPharmaceuticals publication-title: Fed Reg – volume: 11 start-page: 561 year: 1993 end-page: 570 ident: bib6 article-title: Multiuse biopharmaceutical manufacturing publication-title: Bio/Technology contributor: fullname: Harriers – volume: 58 start-page: 403 year: 1995 end-page: 409 ident: bib10 article-title: Concept and organization of aclinical gene therapy lab publication-title: J Cell Biochem contributor: fullname: Quesenberry – volume: 51 start-page: 72 year: 1997 end-page: 77 ident: bib22 article-title: Sterility and sterility assurance publication-title: PDA J Pharm Sci Technol contributor: fullname: Agalloco – volume: 51 start-page: 52 year: 1997 end-page: 59 ident: bib23 article-title: Movingtowards a (microbiological) environmental monitoring programme that can be used to release aseptically producedPharmaceuticals: a hypothesis, a practical programme, andsome results publication-title: PDA J Pharm Sci Technol contributor: fullname: Van De Donk – volume: 10 start-page: 20 year: 1989 end-page: 26 ident: bib9 article-title: Biotechnology facility requirements. 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Part I: Facility and systems design publication-title: BioPharm contributor: fullname: Hill – volume: 58 start-page: 403 year: 1995 ident: 10.1080/146532400539116_bib10 article-title: Concept and organization of aclinical gene therapy lab publication-title: J Cell Biochem doi: 10.1002/jcb.240580402 contributor: fullname: Kittler |
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| Title | Design and operation of a current good manufacturing practices cell-engineering laboratory |
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