| CODE | PAT5604 | ||||||||||||||||
| TITLE | Cell and Tissue Banking | ||||||||||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||||||||||||
| MQF LEVEL | 7 | ||||||||||||||||
| ECTS CREDITS | 6 | ||||||||||||||||
| DEPARTMENT | Pathology | ||||||||||||||||
| DESCRIPTION | This study-unit is intended to cover all aspects of tissue and cell banking from procurement to final release for clinical transplantation. It will cover the significant differences that apply in tissue establishments in contrast to blood or organ ones. The unit will cover all aspects of tissue and cell banking from consenting to procurement, processing and testing options as well as other safety measures. The clinical indications for tissue replacement will also be covered. Study-unit Aims: The study-unit aims to provide a good overview of how tissue and cell establishments work and the regulatory environments in which they operate. Students will be taught the clinical aspects of tissues and cells and their utilization. Learning Outcomes: 1. Knowledge & Understanding: By the end of the study-unit the student will be able to: - Discuss the requirements of GMP facilities; - Describe how tissue and cellular establishments work and the regulatory environments in which they operate; - Provide a detailed account of the overall quality system and the importance of clean room working; - Describe the importance of safety of tissue and cellular products and the interventions at various stages to keep them as safe as possible, from donor screening to final product testing; - Explain the balance between tissue and cell processes utilised and the efficacy of the final product; - Discuss collection and retrieval methodology and banking of different tissues and cells; - Describe the principles of screening and testing of potential donors; - Describe the clinical aspects of tissue and cell transplantation. 2. Skills: By the end of the study-unit the student will be able to: - Employ internationally recognized standards for Tissue and Cell Banking. - Deal with Consent and Data Protection issues. - Perform tissue and cell processing including aseptic techniques, disinfection and sterilisation techniques depending on tissue/cell type. - Operate clean room working practices and apply environmental screening and testing. - Organise and manage tissue and cell storage. Main Text/s and any supplementary readings: Main Texts: - Galea, G. (2010). Essentials of Tissue banking. 1st Edition. Springer. - Essential guides Ed, Warwick RM Fehily D Brubaker S Wiley 鈥� Blackwell 2012. Tissue and Cell Donation; Cell and Tissue Processing; Tissue and cell Clinical use. Supplementary Readings: - Standards for Tissue Banking. American Association for Tissue Banking. 13th Ed 2013. - Rules and Guidance for Pharmaceutical Manufacturers and Distributors (2015). http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medicines/CON203091 - The new Guide to the Quality and safety of Tissues and cells for Human Application EDQM 2015 CoE 2nd Ed. https://www.edqm.eu/en/organ-tissues-cells-transplantation-guides-1607.html Reference: - Appelbaum, F.R., Forman, S.J., Negrin, R.S., Blume, K.G. (2011) Thomas鈥� Hematopoietic Cell Transplantation. 4th Edition. Wiley-Blackwell. To be provided by lecturer: - Reviews and papers from Journals. - EU Directive on Setting Standards of Quality and Safety for the Donation,Procurement, Testing, Processing, Preservation, Storage and distribution of Human Tissues and Cells. http://www.ebmt.org/8TransplantGuidelines/tguide8.html. - FACT-JACIE International Standards for Cellular Therapy Product Collection,Processing and Administration (current edition). http://www.jacie.org/. |
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| ADDITIONAL NOTES | Co-requisite Study-unit: ANA5604 | ||||||||||||||||
| STUDY-UNIT TYPE | Lecture and Independent Study | ||||||||||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | George Galea |
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The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2025/6. It may be subject to change in subsequent years. |
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