biobanco del sspa en isciii y ebisc - jsi2016
TRANSCRIPT
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BIOBANCO SSPAPROYECTOS EUROPEOS
Y PRB2
Málaga Noviembre 2016
Financiado por
Integrado en
Certificado por
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STEM CELL LINES NATIONAL BANK
PRB2
Financiado por
Integrado en
Certificado por
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1.Background2. Available sample collections
3. Quality control measures
4. Additional services
5. Training courses
6. Dissemination activities and publications
7. International projects
REPORT OF ACTIVITIES
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BACKGROUND
ISCIII
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Banco Nacional de Líneas Celulares: BNLC
• Cuatro nodos: Catalunya, Euskadi, C Valenciana y Andalucía (Nodo Coordinador)
• Dirección: ISCIII
• Actividades (mandato legal): Preservación, expansión y cesión de líneas celulares troncales
• Actividad dependiente de la revisión de solicitudes y autorización previa de la Comisión de Garantías y la Comisión Técnica del Banco
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Banco Nacional de Líneas Celulares. BNLC. Depósito y Acceso a las Líneas
• Proyectos que pueden llegar a desarrollar lineas celulares pluripotentes: Comisión de Garantías
• Proyectos que necesitan usar líneas del BNLC: Comisión de Garantías y Comisión Técnica del BNLC
• En Andalucía: ComisiónHomóloga
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Banco Nacional de Líneas Celulares
Oportunidades de Progresión dentro de la plataforma PRB2
• Interconexión y cooperación• Protocolización y sistemática común de trabajo• Ampliación de la cartera de servicios. Apoyo a la
Investigación biomédica• Contactos con otras plataformas/unidades/consorcios• Participación conjunta en proyectos
(nacionales/Internacionales)
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1. Background
2. Available sample collections3. Quality control measures
4. Additional services
5. Training courses
6. Dissemination activities and publications
7. International projects
REPORT OF ACTIVITIES
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AVAILABLE SAMPLE COLLECTIONS
NormalDystrophiesExostosis37
2 1
hESCs (n = 39)
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AVAILABLE SAMPLE COLLECTIONS
hiPSCs (n = 83)
NormalParkinsonDiabetesAutismMultiple sclerosisKidney disorderMetabolic diseaseRetinitis pigmentosaAlzheimerFanconi anemiaDyshtrophies
7
6
3 7
1 1 2
3
38
114
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AVAILABLE SAMPLE COLLECTIONS
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 201602468
101214161820
hESCs hiPSC s
DEPOSITED CELL LINES
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2010 2011 2012 2013 2014 2015 201602468
101214161820
hESCs hiPSCs
AVAILABLE SAMPLE COLLECTIONS
REQUESTED CELL LINES
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1. Background
2. Available sample collections
3.Quality control measures4. Additional services
5. Training courses
6. Dissemination activities and publications
7. International projects
REPORT OF ACTIVITIES
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QUALITY CONTROL MEASURES
1. QUALITY CONTROL FOR CELL LINES
- Mycoplasma detection
- Cell line authentication
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QUALITY CONTROL MEASURES
2. QUALITY CONTROL FOR STORED SAMPLES
• Local and remote alarms for Tº, humidity, O2 and CO2.
• Back-up systems: o CO2 bottleso Empty freezers
• Continuous temperature controls (24-7)
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QUALITY CONTROL MEASURES
3. QUALITY MANAGEMENT SYSTEM CERTIFICATION
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1. Background
2. Available sample collections
3. Quality control measures
4.Additional services5. Training courses
6. Dissemination activities and publications
7. International projects
REPORT OF ACTIVITIES
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Banco Nacional de Líneas Celulares
Cartera de Servicios
• Depósito de líneas• Identificación y codificación• Preservación• Expansión y cesión de líneas• Trazabilidad• Seguimiento de la producción científica
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Banco Nacional de Líneas Celulares
Cartera de Servicios (II)
Banco Nacional Líneas Celulares
Investigadores
Asesoramiento y/o Gestión de un proyecto
Generación de líneas pluripotentes
Caracterización de las líneas
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Banco Nacional de Líneas Celulares
Cartera de Servicios (II)
Banco Nacional Líneas Celulares
Investigadores
Asesoramiento y/o Gestión de un proyecto x
Generación de líneas pluripotentes x
Caracterización de las líneas x
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Banco Nacional de Líneas Celulares
Cartera de Servicios (II)
Banco Nacional Líneas Celulares
Investigadores
Asesoramiento y/o Gestión de un proyecto x
Generación de líneas pluripotentes x
Caracterización de las líneas x
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Banco Nacional de Líneas Celulares
Cartera de Servicios (II)
Banco Nacional Líneas Celulares
Investigadores
Asesoramiento y/o Gestión de un proyecto
x
Generación de líneas pluripotentes X
Caracterización de las líneas x
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ADDITIONAL SERVICES
1. MANAGEMENT OF PLURIPOTENT STEM CELLS PROJECTS
2. PLURIPOTENT STEM CELL LINE GENERATION
• 34 total requests from 2014
Integrative systems
Non integrative systems
Retrovirus mRNA Episomal vectors Sendai virus
Fibroblasts 20 2 2 4
Adipose mesenquimal stem cells
3
CD133+ (SCU) 3
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ADDITIONAL SERVICES
3. PLURIPOTENT STEM CELL LINE CHARACTERIZATION
2015 2016
Karyotyping 34 21
Microsatellite genotyping 28 127
In vivo differentiation 10 4
Immunohistochemistry 7 1
TOTAL 79 152
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1. Background
2. Available sample collections
3. Quality control measures
4. Additional services
5.Training courses6. Dissemination activities and publications
7. International projects
REPORT OF ACTIVITIES
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TRAINING COURSES
1. POSTGRADUATED TRAINING COURSES
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TRAINING COURSES
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TRAINING COURSES
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TRAINING COURSES
2. PRACTICAL COURSES FOR UNDERGRADUATED AND GRADUATED STUDENTS
3. MASTER’S DEGREE
• Biobanks and human sample management in biomedical research (UCV)• Transfusion medicine and advanced cell therapies (UAB)• Regenerative biomedicine (UGR)• Biotechnology (UCV)
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1. Background
2. Available sample collections
3. Quality control measures
4. Additional services
5. Training courses
6.Dissemination activities and publications7. International projects
REPORT OF ACTIVITIES
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DISSEMINATION ACTIVITIES AND PUBLICATIONS
1. DISSEMINATION ACTIVITIES
• European Researchers night
• Science’s week
• Dissemination seminars
• Patients associations meetings
• Interviews in media
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DISSEMINATION ACTIVITIES AND PUBLICATIONS
2. PARTICIPATION IN CONFERENCES• European Society for Biopreservation and Biobanking (ESBB)
• Internatinoal Society for Biological and Environmental Repositories (ISBER)
• National Biobanks Platform (PNB)
• European Society of gene and cell therapy
• International Society for Stem Cell Research (ISSCR)
• Spanish Society for Gene and Cell Therapy (SETGyC)
• International Congress on Neuropathic Pain
• Mediterranean Society for Reproductive Medicine (MSRM)
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DISSEMINATION ACTIVITIES AND PUBLICATIONS
3. PUBLICATIONS
2010 2011 2012 2013 2014 2015 20160
5
10
15
20
25
16
7
14 15
1113
22
Nº
of p
ublic
ation
sYEAR 2010 2011 2012 2013 2014 2015 2016
Nº of publications per year 16 7 14 15 11 13 22
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1. Background
2. Available sample collections
3. Quality control measures
4. Additional services
5. Training courses
6. Dissemination activities and publications
7.International projects
REPORT OF ACTIVITIES
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INTERNATIONAL PROJECTS
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Compañías FPAPfizer (UK)Astra Zeneca (Sw)H Lundbeck (Dk)
Janssen P (be)Novo Nordisk (Dk)UCB Ph. (Be)
Academias y Non for Profit (14 grupos)UK: 5DK:1Ge:6Sp:1 Ned:1
Coord. Adm.Fr
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Mile
sto
nes
Demonstrates alignment between EBiSC and usersStrategic Plan and Vision in White Paper & Business PlanM61
Demonstrates end-to-end capacity of EBiSC operationSOPs for banking and distribution leading to 1st distribution of cell linesM122
Demonstrates capacity to distribute samples to customersOver 200 cell line samples supplied to usersM243
EBiSC actively developing its iPSC line catalogueGap analysis of available iPSC lines leading to commissioning of new lines with standard SOPsM364
Shows impact of the development activities of the EBiSC project
Integration of all development activities into mainstream operationsM365
Shows EBiSC is operating in mature operation modeBabraham facility fully operationalM366
Shows EBiSC is in operating at scale1,000 iPS cell lines availableM367
WhyWhatWhenNo
Banco Europeo de lineas celulares iPSEjecución 36 mDos sedes (UK y Ge)1000 líneas celularesColección basal a partir de las existentes en los centros participantesAportación de 50-100 líneas anuales de cada laboratorio participanteArmonización de prácticas y tecnología de derivación, conservación y expansión
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EBiSC - GA meeting no. 2, Granta Park/UK, 23-24 April 2015
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EBiSC - GA meeting no. 2, Granta Park/UK, 23-24 April 2015
Description
The document compiles standardized instructions for all the process, from the identification and evaluation of the donor (source of the primary tissue) to the shipment
of this material to the processing laboratory facilities.
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OBTENTION OF SAMPLES (SKIN AND BLOOD) as primary tissue for iPSC derivation
This Standard Operating Procedure (SOP) can be adapted for any other alternative primary source of cells for iPSC generation (. Ie. Peripheral or cord blood, urine, bone marrow by amendment of section 3.2.4.1 Protocol for retrieval/biopsy.
Skin
Fat
PROTOCOL FOR EXTRACTION OF SKIN BIOPSIES & VENIPUNCTION
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OBTENTION OF SAMPLES (SKIN AND BLOOD) as primary tissue for iPSC derivation
REPORT OF THE EXTRACTION
LABELED AND SHIPPING TO EACH DESTINATION
Accompanying documentation• Copy of Informed Consent (1) • Copy of Report of donor identification and evaluation
(1)• F_Clinical and social information • F_Check list form the evaluation of donors• F_Physical exam• Copy of report extraction (1) • Copy Request form of serological determinations (if
applicable) (2) • Copy Request form of pathological studies (if
applicable) (2) • Copy of the form for microbiological studies (if
applicable) (2)
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Transport of Samples
• Comply with current regulations and do not present any risk to humans during handling.
• The packaging must be secure and robust enough, depending on the size and weight of the package
• Proper labelling to identify potentially infectious samples and to alert that those samples require special precautions in case of accidental leakage.
REQUIREMENTS PACKAGING, LABELLING AND DOCUMENTATION
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Transport of Samples
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Reception of Samples
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Banco Nacional de Líneas Celulares: BNLC
• Proceso de autorización de derivación y uso muy
complicado. / No se realiza seguimiento
• Asimilación de células embrionarias e iPS como
iguales: Obligatoriedad de depósito. Participación
en proyectos Internacionales.
Desobediencia/Rebeldía
• Proliferación de nodos. Financiación /
Supervivencia
• Otros usos de las líneas: Docencia. Puesta a punto
de técnicas. Validación
• Pre-embriones donados a la ciencia
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WP2 Samples & Biobanking
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Cross-Sectional Study
WP Structure of PRECISESADS
Preclinical Study
WP1 - Coordination
WP9 – Knowledge dissemination & training
WP2 – Samples & Biobanking
WP3 – Clinical Data Management
WP4 – Genomics
WP5 – Cellular & Cytometry
WP6 – Proteome & Metabolome
WP7 – Tissue Taxonomy
WP8 – Bioinformatics & Biostatistics
ValidatedDiseaseClusters
CandidateDiseaseClusters
ValidationInception
cohort
PRECISESADS
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Flow of Biological Samples.
Collection of Samples and Clinical Data
Clinical Data Registry
Flow Cytometry & cell separation
Biobank/Centers Processing: NNAA, Serum,
Plasma, Urine
Cytokines(serum)
Metabolomics (plasma)
Transcriptomics (RNA)
Methylation(DNA)
Phenotyping(Cells)
Biobank Storage: NNAA, Serum, Plasma, Urine
Project & Biobank DataBase
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Flow of Biological Samples. Collection Centre / Local Lab
Biobank
Reference Lab.
Project & Biobank DataBase
Tasks done in the collection centers or local laboratories
Tasks done in Biobank
Tasks done in Reference’s Laboratory
Data Transfer
Local Sample’s shipment
External Sample’s shipment
Biobank / Collection Centre
Tasks done in the collection centers and in Biobank
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N WP and Tasks Time-lines S1 S2 S3 S4 S5 S6 S7 S8 S9 S10
2 Sample Collection and Biobanking 1-60
2.1 Establishment of a protocol for the enrollment of patients and their samples (cross-sectional cohort) 1-6
2.2 Full recruitment of the first288 SADs patients and healthy controls + collection of biological samples 3-12
2.3 Establishment for a protocol for the recruitment of the inception cohort, and recruitment. 1-52
2.4 Procurement of ethical approval (ETHICS TASK) 1-52
2.5 Full recruitment of the complete set of 2000 SAD patients and 666 controls + biological samples 8-24
2.6 Protocols for sample’s package preparation, labelling and shipment 1-6
2.7 Organize the centralized preservation and banking management of biological samples. 1-60
2.8 Maintenance and sampling of the pre-clinical models 6-60
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PHASE 1ª CROSS-SECTIONAL COHORT
PHASE 2 CROSS-SECTIONAL COHORT
INCEPTION COHORT
DONATIONS 302 2921 626
PROCESSING
SAMPLE EXTRACTION x x x
CYTOMETRY / CELL SEPARAT. x x x
CITRATE PLASMA x x x
SERUM x x xPLASMA/DNA x x x
URINE x x xRNA x x xTEMPORAL STORE x x x
SENDING TO BIOBANCK DOCUMENTS AND SAMPLES DOCUMENTS AND SAMPLES DOCUMENTS AND SAMPLES
General steps on WP2: Biobanking and samples
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DO NOT USE THE KITS AFTER THE EXPIRATION DATE PRINTED ON THE LABEL ON TOP. STORE THE KITS AT (18-25)ºC.
SENDING THE KITS FROM BIOBANK
PHASE 1 A CROSS SECTIONAL COHORT
PHASE 2 CROSS SECTIONAL COHORT
INCEPTION COHORT
TIME ELAPSED FROM EXTRACTION TO THE STORAGE OF THE ALIQUOTS CAN NOT EXCEED
2 HOURS.
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The kit contains Necessary tubes in two bags for samples collection and processing with their labels (OMIC code). DO NOT USE OTHER CODES - DO NOT USE OTHER LABELS
DO NOT USE IT AND OPEN A NEW KIT (THIS POINT WILL BE NOTICED TO BIOBANK).
Documentation
ONE KIT, ONE DONATION!!! WE WILL SEND KITS WITH TUBES AND LABELS JUST IN CASE OF REPLACEMENT.
IF ANY INCIDENT IS DETECTED TO
ONE KIT COMPLETE THE KIT CHECKLIST
SENDING THE KITS FROM BIOBANK
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Collecting the samples COLLECTING THE SAMPLES
BAG CONTAINING OBTENTION MATERIAL.
YOU NEED THIS BAG
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Flow of Biological Samples.
Collection of Samples and Clinical Data
Clinical Data Registry
Flow Cytometry & cell separation
Biobank/Centers Processing: NNAA, Serum,
Plasma, Urine
Cytokines(serum)
Metabolomics (plasma)
Transcriptomics (RNA)
Methylation(DNA)
Phenotyping(Cells)
Biobank Storage: NNAA, Serum, Plasma, Urine
Project & Biobank DataBase
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Extracción de ácidos nucleicos y
biología molecular
FenotipadoCitogenética
Almacén ysoporte técnico
Estabilización de muestras
Preservación y conservación de
muestrasCultivos celulares
ST
Biobanco del Sistema Sanitario Público de AndalucíaProcesamiento y preservación centralizada de muestras
AN
Experimentación animal
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PHASE 1ª CROSS-SECTIONAL COHORT
PHASE 2 CROSS-SECTIONAL COHORT
INCEPTION COHORT
DONATIONS 302 2921 626
PROCESSING
SENT KITS 302 2112 469
EDTA PLASMA302 206 0
CITRATE PLASMA 302 18 0
SERUM 302 228 19DNA 302 278 47
URINE 302 232 2RNA 302 491 0
DOCUMENTS AND SAMPLES1497 DOCUMENTS AND SAMPLES RECEIVED IN
BIOBANK
253 DOCUMENTS AND SAMPLES RECEIVED IN
BIOBANK
CURRENT STATE: Biobanking and samples
COM
PLET
ED
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www.juntadeandalucia.es/salud/biobanco
Financiado por
Integrado en
Certificado por
NODO GRANADA
THANKS