Dedication to quality

Quality has always been a key focus for IBBL, whose mission is to provide biospecimen-related services and a robust biobanking infrastructure. In 2016, IBBL successfully pursued this mission by extending the scope of its ISO 17025 accreditation, passing follow-up audits for its certifications and providing an objective quality assessment to 94 laboratories working with biospecimens worldwide.

ISO 9001:2008 and NF S96-900:2011 certified

ISO 17025:2005 accredited

NGS 16s rRNA accredited

ISO technical committee TC 276 “Biotechnology”

2016 biospecimen PT programme

Making history in the biobanking world

IBBL’s continuous efforts in increasing the quality of its operations were again recognised in 2016 as the end of the year came along with marvelous news: not only did the biobank pass the follow-up audit for ISO 17025 (general requirements for the competence of testing and calibration laboratories), but it also extended the scope of the accreditation to four additional testing methods developed in house:

  • DNA Cross-Linking Assessment
  • Long-Range PCR
  • Human sCD40L Quantification in Serum
  • Next-Generation 16S rRNA Gene Sequencing

Whereas the first three assays were developed for the purpose of biospecimen quality control, the latter, unique for biobanks, is a characterisation method dedicated to provide accurate microbiome profiling data. As good news always come in pairs, this major achievement came after successful follow-up audits for ISO 9001 (general quality management) and NF S96-900 (quality of biological resource centres and biological resources).

« The next-generation 16S rRNA gene sequencing consists in identifying the whole set of bacteria within a given sample of any kind, be it saliva or stool to name a few. It provides scientists with a reliable full-length insight of an individual’s bacterial profile. »
Lorieza Neuberger-Castillo
IBBL’s Microbiome & Sequencing Assistant Scientist

Bringing its expertise to ISO

Reaching those three milestones would have never been possible without the commitment of the staff and exemplary management to the quality system set up by Dr Sabine Lehmann, Quality Manager at IBBL. Trusted as a biotech leader in Luxembourg, IBBL has been bringing its expertise to the ISO technical committee TC 276 “Biotechnology” in the persons of Dr Lehmann and Dr Betsou. Under this committee, delegates from 28 countries are currently developing 11 ISO standards in the field of biotechnology, including biobanking. For its part, IBBL has been actively involved in the ongoing development of two standards: ISO 20387 to define the general requirements for biobanking, and ISO 21899 to establish the general requirements for the validation and verification of processing methods for biological material in biobanks.

« Our quality management system is key in our strategy to maintain our status as an international centre of excellence in biobanking and to provide bioservices of high quality to our clients. »

Sabine Lehmann
IBBL’s Quality Manager

Providing an objective quality assessment

IBBL’s biospecimen proficiency testing (PT) programme is a cornerstone of its dedication to quality. Endorsed by the International Society for Biological and Environmental Repositories (ISBER), the global scientific society in the biobanking world, the PT programme is an external quality assessment tool that enables laboratories working with biospecimens worldwide to verify and benchmark the precision, accuracy and efficiency of their laboratory methods. In 2016, the programme drew 94 participating laboratories from 26 countries, which registered for a total of 354 PT schemes. IBBL also expanded this year’s edition to 18 testing and processing schemes by adding the following five:

  • Microbial DNA Extraction from Saliva
  • Microbiol DNA Extraction from Stool
  • Cell Free DNA Extraction from Whole Blood
  • DNA Extraction from Frozen Tissue
  • RNA Extraction from Frozen Tissue

To develop schemes that are fit for biobank processing laboratories, IBBL collaborated with European partners. The scheme for Cell Free DNA Extraction from Whole Blood was initiated within the CANCER-ID consortium for example.

« The PT programme is an integral part of a biobank laboratory’s quality management system. All laboratories working with biospecimens should regularly monitor their performance to guarantee the best outcomes from downstream scientific research. »

Olga Kofanova
IBBL’s Team Leader Biospecimen Quality

Acting ahead of time

In 2017, three elements will trigger further advances of IBBL’s quality management system (QMS): the implementation of an electronic document management system for the administration of quality documents, the move to a permanent building in Dudelange with adaptations of building-related processes, as well as the modernisation of the QMS according to the new version of ISO 9001.

Keep on reading our 2016 annual report: