Lessons Learned: Challenges experienced by the NHLS/SU BIOBANK (NSB), a South African perspective

Transcription

1 Lessons Learned: Challenges experienced by the NHLS/SU BIOBANK (NSB), a South African perspective C Swanepoel, S Isaacs, F Abulfathi, T Reid, M February, J Bell, R Grewal, A Christoffels, EA Abayomi nsb@sun.ac.za Fakulteit Geneeskunde en Gesondheidswetenskappe Faculty of Medicine and Health Sciences

2 Tygerberg : 1,400 bed multi-disciplinary teaching hospital

3 BIOBANKING SCIENCE IN AFRICA Great stride has been made in promoting biobanking science in Africa H3Africa, B3Africa, BCNET, ISBER and ESBB, GET consortia Increased opportunities to engage in international collaborative research efforts Primary research are conducted in Africa Lead to capacity building Reducing the fear of bio-piracy that hindered research and discovery on the continent Implementation of best practices through benchmarking exercises rapidly increasing standardization and harmonization of biobanking practices HOWEVER there is still a lot of work that needs to be done NSB has gained extensive biobanking experience over the years and serve as a tool/link that aid in the collection, processing, and storage of human biospecimens. 3

4 NSB STRATEGIC VISION: TO PROMOTE A GREATER UNDERSTANDING OF BIOBANKING SCIENCE & TECHNOLOGY & THE ASSOCIATED ELSI TROUGH: 4 Managing, process and preservation of high quality biospecimens Maintaining effective biospecimen transport logistics Developing business sustainability program for biobanking operations Implementing cost effective/innovative technology for preservation and transportation. Eg. Room temperature storage and room temperature stabilisers for transportation purposes as sustainable, energy efficient approaches. Focusing on the science of cryopreservation Standardization and harmonization Education & training Integrating Clinical and laboratory information management systems ELSI and CE and PE Adding value via renewable cell line creation (Future development)

5 NSB Overview Registered with SU- HREC as fully functional operated biobank N13/10/157 & N15/10/119 Compliance with NIC and ISBER Best Practices All assays are EQA certified (ISBER PROFICIENCY TEST) IATA and GLCP certified Established Risk Management & Emergency Plans & Sustainability plan Experience Sample Logistics Management (Africa, Europe & USA) CE- Biobank pamphlet & video involvement through centre for medical ethics and law, Stellenbosch University in association with members of ACSR/AMC 5

6 Services Sample Collection Logistics Management: Kit Development Shipping (Permits, MTA s, IATA) Laboratory Services: QC: DNA Extractions RNA Extractions PBMC Isolations Cell culture Nucleic Acid QC Spectroscopy: Nanodrop, Qubit gdna gel electrophoresis β-globin PCR RIN: Bioanalyzer: Agilent Cell Viability (Automated & Flow-based) Mycoplasma Testing (PCR-based Assay) Urine QC Testing (Microalbumin, Ph, PrCr, Ca) via clinical lab Serum/Plasma Hemolysis:Visual Grading & Turbidity Storage: Certified by EQA programme 4 o C, -20 o C, -80 o C, LN2 (-196 o C) & Room temperature (23 o C) *Sample Types -Whole Blood -Plasma/Serum -Cells -NA -Urine -Breast Milk - Saliva LIMS and QA *Training/Workshops - NA Extraction - PBMC Isolations - Shipping - Labeling - Biobanking QMS/QC --Storage --Risk Management - Molecular Techniques

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8 Major outputs since Publications: 10 Biobanking related articles by NSB members Oral Presentations at various meetings (Local and International): 19 (Staff & Students) Poster presentations at various meetings (Local and International): 9 (Staff & Students) Benchmarking and mentoring program to biobanks in SL, Liberia, Guinea, Nigeria Participation in editing and reviewing the Biobanking section in the 2015 DOH Ethics and Health Research guidelines In association with Centre of Medical Law and Ethics & ACSR (Anat Path) - Develop a Biobank & Genetic Pamphlets and video as part of CE initiative 8 Developing/Expanding CE, PE and outreach initiative/program

9 B3Africa Open Forum & Training Week

10 10 PUBLIC ENGAGEMENT 1 st NSB Biobank Scientific Exhibition

11 OUTREACH CE & PE 11

12 12 Lessons Learned: Technical, regulatory and logistical considerations

13 13 Lessons Learned: Technical, regulatory and logistical considerations

14 NATIONAL SCIENTIFIC RESEARCH COLLECTIONS PLATFORM (NSCRP) To address the needs and shortcomings of collections and biobanking, the establishment of a National Scientific Research Collections Platform (NSRCP) is proposed. The overall objectives of the Platform are to: i. Ensure long-term security and access to collections and associated data through the development and implementation of common policies, standards and collection strategies (including human capital and research capacity development) and research infrastructure; ii. Catalyse ground-breaking interdisciplinary research that relies on access to scientific collections and that addresses questions of relevance to SA society; and iii. Explore and drive opportunities for enhancing economic potential of knowledge and products generated through collections-based research. The envisaged Platform is a virtual network with nodes represented by clusters of similar type of collections in SA 14

15 Past & Present collaborators and funders 15