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Introduction: Facility Design

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Cell Therapy

Abstract

This chapter provides an introduction to the design of current good manufacturing (cGMP)/good tissue practices (cGTP) facilities in academic institutions. It is followed by separate chapters that provide information on a number of such facilities. In addition, there are chapters on cord blood banks and on a vector production facility.

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References

  1. Code of Federal Regulations. Human cells, tissues, and cellular and tissue-based products, Part 1271. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271. Last accessed 13 July 2020.

  2. Code of Federal Regulations. Drug good manufacturing practices (GMP). Title 21, Parts 210 and 211. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211 Last accessed 13 July 2020.

  3. European Commission (2017) Good manufacturing practice guidelines on good manufacturing practice specific to advanced therapy medicinal products. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf. Last accessed 13 July 2020.

  4. International Standards Organization. Cleanrooms and associated controlled environments. International Standards ISO 14644-1 https://zoser.com.co/wp-content/uploads/2015/10/ISO%2014644-1%20Version%202015.pdf. Last accessed 13 July 2020.

  5. United States Pharmacopoeia <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments. http://ftp.uspbpep.com/v29240/usp29nf24s0_c1116.html/. Last accessed 13 July 2020.

  6. Mecart Cleanrooms Website: Cleanroom Classifications (ISO8, ISO7, ISO6, ISO5). https://www.mecart-cleanrooms.com/learning-center/cleanroom-classifications-iso-8-iso-7-iso-6-iso-5/. Last accessed 13 July 2020.

  7. High-Tech Conversions Website. Cleanroom gowning requirements. https://high-techconversions.com/cleanroom-gowning-requirements/. Last accessed 13 July 2020.

  8. European Medicines Agency. human regulatory, good manufacturing practice. https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice . Last accessed 13 July 2020.

  9. European Medicines Agency. Eudra GMDP Website. Compliance with good manufacturing practice. http://eudragmdp.ema.europa.eu/inspections/gmpc/index.do. Last accessed 13 July 2020.

  10. Food and Drug Administration. Pre-operational reviews of manufacturing facilities. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/field-management-directives/pre-operational-reviews-manufacturing-facilities. Last accessed 13 July 2020.

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Acknowledgments

This work was supported in part by a Core grant (RP180785) from the Cancer Research and Prevention Institute of Texas.

I would like to thank Sara Richman of the Center for Cell and Gene Therapy for reviewing this chapter.

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Correspondence to Adrian P. Gee .

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Gee, A.P. (2022). Introduction: Facility Design. In: Gee, A.P. (eds) Cell Therapy. Springer, Cham. https://doi.org/10.1007/978-3-030-75537-9_15

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