Operations are run under the control of a well-defined Quality Management System (QMS) and certified for the following norms:
ISO 9001:2015 (certification) that specifies the general requirements for quality management systems in client-based organisations
ISO 17025:2017 (accreditation) that specifies the general requirements for the competence of testing and calibration laboratories for the following methods:
DNA Quantification by Spectrofluorometry;
Nucleic Acid Quantification by Spectrophotometry;
RNA Integrity Measurement;
16s rRNA Gene Sequencing.
Finally, operations are also compliant with the principles of ISO 17043:2010 (Proficiency Testing) and with ISO Guide 34:2009 Reference Material Production.
1. Biospecimen Services and Data Generation
1.1. BIOSPECIMEN SCIENCE
Provide direct research support to the Biorefinery team, other research groups within LIH and future TMOH collaborators to address specific biospecimen-related issues that compromise the quality or efficiency of their work.
Carry out research that improves the efficiency by which clinical biospecimens are utilised by the research community and generally, enabling more research to be performed with less clinical material.
Disseminating the expertise of IBBL and LIH by publishing high quality Biospecimen Science Research papers and engaging with the global research community in matters relating to Biospecimen Science.
1.2.BIOREFINERY (ISO 9001:2015 CERTIFICATION)
1.2.1. METHOD VALIDATION AND IMPLEMENTATION
Conducting pre-process/characterisation feasibility and optimisation of new technologies to establish best practices for biospecimen processing
Formal method validations and implementation of novel methods e.g. cfDNA and Exosomes isolations
Scientific Equipment Supervision: Implementation, validation and tracing the complete life cycle of scientific equipment
1.2.2. BIOSPECIMEN PROCESSING
Highly standardised and automated processing of biospecimens from continuous routine and static clinical collections
Highly standardised and automated transformation and derivation of biospecimens
Highly specialised processing and characterisation e.g. 16S Sequencing, Elispot and ddPCR
All operations performed under fully traceable Laboratory Information Management System (LIMS)
1.2.3. PRODUCTION QUALITY & PROFICIENCY
Quality assessment, control and characterisation of biospecimens and derivatives (internal and external) applying ISO-17025 accredited methods
Provision of reference material for biorefinery routine processing
Proficiency testing programme provider: Assessment of participant compliance with international standards and good practices
1.3. NATIONAL CYTOMETRY PLATFORM (ISO 9001:2015 CERTIFICATION)
Technological advice, experimental design and training for flow cytometry, mass cytometry and imaging cytometry and microscopy
Instrument operations and / or realisation of complete experimental pipelines
Multidimensional data analysis from sample analysis to data integration and statistics
1.4. PATHOLOGY TEAM
Histological processing of tissue samples
Digitalisation of microscopic images of samples
Pathological characterisation of tissue samples
As an accredited and certified biobank we operate under a strict quality management system and all our sample logistics and storage activities are carried out by experienced staff following standard operating procedures. We are equipped with 24/7 temperature monitoring and on-call staff, alarm systems, back-up freezers and generators, ensuring the security of your samples.
Study kit design & provision
Logistics of biological samples and study related goods in compliance with IATA regulations
Biological sample receipt, inventory and storage
Storage equipment and related environmental monitoring management
5.3. TRANSLATIONAL BIOMARKER GROUP
Full-fledged or partial technical biomarker validation, encompassing three modules:
pre-analytical validation, to assess the most common pre-analytical variables undermining biomarker robustness
analytical validation, to verify method fitness-for-purpose
clinical verification, to perform a clinical validation on a smaller scale
Each module can be performed individually or in combination with another module. Module sequence can be exchanged on a case-by-case BM scenario.
Consultancy services for studies revolving around biomarker discovery, also in the context of grant applications Biomarker measurements, including platform bridging (ex.: qPCR to ddrPCR, ELISA to capillary Western Blot, etc.)
5.4. BIS – BUSINESS & INTEROPERABILITY SOLUTIONS
Data Governance & Intelligence - providing services related to Data Management, Data Analysis, Data Modelling, Reporting & Dashboarding
Interoperability & Medical Informatics – ensuring data integration & exchange based on medical standards and terminologies
DevOps & Architecture - ensuring Software Engineering & Support Business Applications/Solutions
Project Management & Business Analysis - IT Project Management, Requirement Gathering