A PIONEER IN QUALITY
AND STANDARDISATION

2017 was marked by four important steps with regard to quality. Internationally, the ISO/DIS 20387 biobanking standard draft was approved and the draft ISO/AWI 21899 norm published. Internally, IBBL successfully passed the recertification audit for ISO 9001:2008 and started preparing to become an authorised GMP storage infrastructure.

“We are delighted that IBBL could contribute to the advancement of biobanking operations.”

Sabine Lehmann

PhD, Quality Manager

International collaboration

Since 2013, IBBL has been working with international experts on the development of dedicated biobanking norms. Specifically, IBBL’s Quality Manager Dr. Sabine Lehmann and project co-leader Dr. Georges Dagher contributed to the elaboration of the official ‘new work item proposal’ (NWIP) for the ISO 20387 biobanking standard. The document, being devised under Working Group 2 of the ISO technical committee TC 276 ‘Biotechnology’, has been conceived as an ‘umbrella standard’ detailing the general requirements for biobanking, under which other more specific standards will be elaborated. The year 2017 saw the collaborative efforts of the working group’s 150 experts pay off, with the Draft International Standard (ISO/DIS 20387) being released in July to the international community for voting and comments. The result of the ballot was an almost unanimous approval. “We could not be more satisfied with this outcome! Not only does the vote highlight the international dimension of the approval of the document, but it also further proves the case for developing a tailored biorepository standard. We are delighted that IBBL could contribute to the advancement of biobanking operations”, comments Dr. Lehmann.

Standards… and more standards!

This strong international cooperation has also been paving the way towards the development of yet another ISO standard. Indeed, Dr. Fay Betsou, Chief Science Officer at IBBL, has brought her experience to the conception of the draft version of ISO/AWI 21899, a complementary norm aiming to establish the general requirements for the validation and verification of processing methods for biological material in biobanks. The draft document was prepared and revised in November 2017, and will undergo a similar ballot once finalised. “The work of the international biorepository community towards the standardisation of its activities must go on. We are making enormous progress in terms of ensuring the quality and fitness-for-purpose of biospecimens through evidence-based experimental method validation. However, being accredited and certified to existing norms is not of itself enough. We would like to see the development of international biobanking technical standards supporting improved reproducibility of research results”, explains Dr. Betsou.

A biobank like no other

Having a solid Quality Management System (QMS) in place pays off in every respect. Not only does it build customer trust, but it also allows IBBL to expand its activities. In 2017, work started on ensuring compliance with Good Manufacturing Practices (GMP), according to the Grand-Ducal Regulation of 30 August 2007 determining technical requirements for the distribution, procurement and control of tissues and cells of human origin (which is in turn based on EU Directive 2004/23/EC). Compliance with this legislation will enable IBBL to offer a new type of service, namely the storage of human cells and tissues to be used in downstream therapeutic purposes (“GMP storage”), adding to the traditional biobanking service of tissue and cell storage for research applications. This will allow IBBL to become an authorised GMP storage infrastructure (known as an authorised “tissue bank”) and be positioned at the interface between research and the clinic. In practical terms, 2017 saw the extension of IBBL’s QMS to address customer needs, as well as the purchase of the relevant equipment and the design of dedicated storage facilities in the new building to fully align with GMP storage requirements.

Quality is particularly critical when it comes to the storage of samples of human origin for therapeutic applications, due to the potential repercussions on human health, therefore requiring the repository room to possess a specific ventilation system to keep it isolated and impeccably clean. “The storage of human cells and tissues according to GMP requires a very complex QMS and is not an activity that biobanks typically pursue. However, our QMS was mature enough, requiring only a few modifications to be compliant, so it felt like a natural progression of our activities”, explains Dominic Allen, Chief Operating Officer at IBBL.

“The storage of human cells and tissues according to Good Manufacturing Practices requires a very complex Quality Management System. However, ours was mature enough, so it felt like a natural progression of our activities.”

Dominic Allen

Chief Operating Officer

Client satisfaction in our DNA!

Finally, the year ended with an additional achievement to put under the belt. In Q3 2017, IBBL successfully passed the recertification audit for ISO 9001:2008 (quality management systems – requirements) at the conclusion of the third surveillance year, with its entire QMS being reassessed. The certification was issued by the TÜV Rheinland group in December 2017. “ISO 9001 is an appropriate standard for the certification of a biobank’s QMS, since it ensures the consistency of its core processes. As a highly customer-oriented institute, IBBL wants to officialise its dedication to client satisfaction and continuous improvement. Obtaining the recertification is therefore an earned recognition of our efforts”, states Dr. Betsou.

The future through the ‘quality lens’

Looking forward, prospects for IBBL in terms of quality are bright, with the Final Draft International Standard (ISO/FDIS 20387) set to be released for voting in Q2/2018. Moreover, in line with the requirements of the national legislation, IBBL will seek authorisation from the Luxembourg Ministry of Health in 2018 to become an authorised GMP storage facility (“établissement de tissus”). Finally, the ISO 17025:2005 reaccreditation audit will take place in Q1 2018.

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