A model proposal for preservation process validation in microbial biobanks

Purpose – Microbial biobanks (mBb) are considered a key element in driving the growth of biotechnology. The Organisation for Economic Cooperation and Development (OECD) recommended mBb to ensure an effective and consistent preservation of microorganism biodiversity by validating its preservation process. As it does not exist any guidance for this endeavour, our goal is to develop a model for the preservation process validation and provide guidance on implementation.
Methodology – The model for the preservation process validation was developed based in the pharmaceutical process validation. Guidance on implementation was developed based in fungi cryopreservation procedures.
Findings –  Current quality management in mBb follows a quality by testing approach which is not sufficient to ensure an effective microorganism preservation. Validation of tests and assays is not sufficient to ensure an effective microorganism preservation as well. At least theoretically, it is possible to embrace a process validation in mBb based on scientific approaches such as risk assessment, quality by design and formal experimental design.

Practical implications – The achievement of preservation process validation will enable mBb to consistently preserve the world microbial diversity making it available for further developments which are expected to drive major developments in biotechnology and foster bioeconomy.
Originality/value: Original paper

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validation, biobank, BRC, quality-by-design