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Titlebook: Cell Therapy; cGMP Facilities and Adrian Gee Book 2009 Springer-Verlag US 2009 cancer.cell.gene.gene therapy.genes.regulation.research.ste

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Maritta Heisel,Jeanine Souquières to the building which is being expanded from 12 to 20 stories (Figs. 7.1a and b). This has given us the opportunity to redesign the space based on our experience working in the present facility. This chapter describes what changes have been made based on lessons learned from working in the previous facility for nearly 10 years.
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or tenet of GMP/GTP is “if an activity was not documented, it was not done.” Both quality oversight and documentation are largely facilitated by use of Standard Operating Procedures (SOPs). This chapter reviews the structure and development of SOPs.
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- Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Labot and manufacturing of biological products required for University investigator-initiated research protocols, external partnerships, and contracts for cellular product manufacturing. This chapter describes the design features of these two laboratories.
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