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BSI PAS 84:2008

BSI PAS 84:2008

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Regenerative medicine. Glossary

Published By Publication Date Number of Pages
BSI 2008 38
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PDF Pages PDF Title
3 Contents
Introduction 1
1 Scope 2
2 General 2
3 Cell and tissue components 6
4 Non-cellular components 10
5 Cell and tissue procurement 10
6 Measurement and analysis 11
7 Manufacturing and production 14
8 Clinical trials 18
Annexes
Annex A (informative) Regulatory terms 22
Bibliography 26
List of tables
Table A.1 – Regulatory terms for clinical trials 22
Table A.2 – Regulatory terms for products and therapies 23
4 Foreword
5 a) Human Tissue Act 2004 [1].
b) European Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [2].
c) Human Fertilisation and Embryology Act 1990 [3].
d) European Directive 2001/83/EC relating to medicinal products for human use [4] as amended by European Directives 2002/98/EC [5], 2003/63/EC [6], 2004/24/EC [7], 2004/27/EC [8] and European Regulations No. 1901/2006 [9] and No. 1394/2007 [10].
7 Introduction
8 1 Scope
a) associated with the naming of types of regenerative medicine products and therapies;
b) that describe materials, processes, methodologies and applications within regenerative medicine.
2 General
2.1 allogeneic
2.2 allograft
2.3 apoptosis
2.4 autograft
2.5 autologous
2.6 bioaesthetics
9 2.7 cancer vaccine
2.8 cell based medicinal product (CBMP)
2.9 cell culture
2.10 cell therapy
2.11 cloning
2.12 cosmesis
2.13 drug substance
2.14 ex vivo
2.15 extracorporeal
2.16 gene therapy
10 2.17 genotype
2.18 heterologous use
2.19 heterotopic
2.20 homologous use
2.21 homotopic
2.22 in vitro
2.23 in vivo
2.24 informed consent
2.25 intermediate
2.26 minimal manipulation
2.27 necrosis
2.28 organ
11 2.29 passage
2.30 passage number
2.31 phenotype
2.32 plating efficiency
2.33 population doubling
2.34 products
2.35 raw material
2.36 regen
2.37 regenerative medicine
2.38 reproductive cloning
2.39 seeding density
2.40 senescence
12 2.41 substantial manipulation
2.42 syngeneic
2.43 therapeutic cloning
2.44 therapy
2.45 tissue
2.46 tissue engineering
2.47 transplantation
2.48 xenogeneic
2.49 xenograft
3 Cell and tissue components
3.1 admixed embryo
3.2 adult stem cell
13 3.3 adventitious
3.4 blastocyst
3.5 cell expansion
3.6 cell line
3.7 cell migration
3.8 contaminant
3.9 continuous cell line
3.10 cord blood stem cell
3.11 cryopreservation
3.12 cryoprotectant
3.13 culture medium
3.14 cytokine
14 3.15 cytoplasmic hybrid embryos (cybrid)
3.16 de-differentiation
3.17 defined medium
3.18 differentiation
3.19 embryonic stem cell
3.20 embryonic stem cell line
3.21 extracellular matrix (ECM)
3.22 feeder cell
3.23 fetal stem cell
3.24 finite cell line
3.25 haematopoiesis
3.26 haematopoietic stem cells (HSC)
3.27 immortal
3.28 induced pluripotent stem (IPS) cells
15 3.29 inner cell mass (ICM)
3.30 major histocompatibility complex
3.31 marrow stromal cell
3.32 mesenchymal stem cell
3.33 multipotent
3.34 mycoplasma
3.35 nullipotent
3.36 pathogen
3.37 pluripotent
3.38 precursor cell
3.39 primary cell culture
3.40 somatic stem cell
3.41 stromal cells
16 3.42 stem cell
3.43 somatic cell nuclear transfer (SCNT)
3.44 totipotent
3.45 trophoblast
3.46 vitrification
4 Non-cellular components
4.1 bioactive agent
4.2 biomaterial
4.3 excipient
4.4 growth factor
4.5 scaffold
5 Cell and tissue procurement
5.1 cell bank
5.2 current Good Clinical Practice (cGCP)
17 5.3 donation
5.4 provenance
5.5 serious adverse event
5.6 tissue bank
5.7 tissue establishment
5.8 traceability
6 Measurement and analysis
6.1 cell authenticity
6.2 biocompatibility
6.3 biomarker
6.4 cell morphology
6.5 cell viability
18 6.6 comparative genomic hybridization (CGH)
6.7 contamination
6.8 current Good Cell Culture Practice (cGCCP)
6.9 DNA profiling
6.10 epigenetic
6.11 gene expression profile (transcriptome)
6.12 flow cytometry
6.13 fluorescence activated cell sorting (FACS)
6.14 haemocytometer
6.15 histocompatability
6.16 histology
6.17 immunocytochemistry
6.18 immunohistochemistry
6.19 impurity
19 6.20 karyotyping
6.21 magnetic activated cell sorting (MACS)
6.22 microarray
6.23 polymerase chain reaction (PCR)
6.24 porosity
6.25 protein expression
6.26 purity
6.27 safety
6.28 surface marker
6.29 tissue typing
6.30 toxicology
6.31 tumour
6.32 tumourigenicity
20 7 Manufacturing and production
7.1 aseptic
7.2 batch (or lot)
7.3 bioprocessing
7.4 bioreactor
7.5 cleanroom (or clean facility)
7.6 cost benefit analysis
7.7 current Good Laboratory Practice (cGLP)
7.8 current Good Manufacturing Practice (cGMP)
7.9 current Good Tissue Practice (cGTP)
21 7.10 dose
7.11 in-process control
7.12 investigational medicinal product (IMP)
7.13 manufacture
7.14 marketing authorization
7.15 post market surveillance
7.16 potency
7.17 preservation
22 7.18 process analytical technology (PAT)
7.19 processing
7.20 qualification
7.21 qualified person (QP)
7.22 qualified person responsible for pharmacovigilance (QPPV)
7.23 quality
7.24 quality assurance (QA)
7.25 quality control (QC)
7.26 quality system
23 7.27 release criteria
7.28 risk
7.29 risk analysis
7.30 risk management
7.31 scale out (or scale horizontally)
7.32 scale up (or scale vertically)
7.33 specification
7.34 stability testing
7.35 standard operating procedure (SOP)
7.36 sterile
7.37 translation
24 7.38 validation
7.39 whole bioprocessing
8 Clinical trials
8.1 adverse event
8.2 adverse event reporting
8.3 adverse reaction
8.4 arm
8.5 baseline
8.6 chief investigator
8.7 clinical investigator
8.8 clinical translation
25 8.9 clinical trial
8.10 control
8.11 dose finding study
8.12 double blind study
8.13 eligibility criteria (or inclusion and exclusion criteria)
8.14 endpoint
8.15 ethics committee
8.16 immunorejection
8.17 immunosuppression
8.18 minimum effect dose
8.19 non-clinical study
8.20 pharmacodynamics
26 8.21 pharmacokinetics
8.22 pharmacology
8.23 pharmacovigilance
8.24 phase 0 trial
8.25 phase I/II trial
8.26 phase II trial
8.27 phase III trial
8.28 phase IV trial
8.29 placebo controlled study
8.30 principle investigator
27 8.31 protocol
8.32 randomized trial
8.33 sham procedure
8.34 side effect
8.35 single blind
8.36 subject
28 Annex A (informative) Regulatory terms
Table A.1 Regulatory terms for clinical trials
29 Table A.2 Regulatory terms for products and therapies
30 Table A.2 Regulatory terms for products and therapies (continued)
32 Bibliography
[1] GREAT BRITAIN. Human Tissue Act 2004. London: The Stationery Office.
[2] EUROPEAN COMMUNITIES. 2004/23/EC. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on set…
[3] GREAT BRITAIN. Human Fertilisation and Embryology Act 1990. London: The Stationery Office.
[4] EUROPEAN COMMUNITIES. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community…
[5] EUROPEAN COMMUNITIES. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standard…
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[8] EUROPEAN COMMUNITIES. Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004 amending Directive 20…
[9] EUROPEAN COMMUNITIES. Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on med…
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BSI PAS 84:2008
$9.75