At the NSW Health Statewide Biobank (NSWHSB), as part of our quality management system, in accordance with our ISO-9001 accreditation, any new procedure or equipment must first be validated as fit-for-purpose prior to implementation into our workflows. Developing this validation pipeline posed a challenge, as although standards and guidelines like ISO-20387, ISO-21899, and the ISBER best practices are available, there are limited published examples of method validations.
Recently, we validated and implemented an alternative method for isolating peripheral blood mononuclear cells (PBMCs). We conducted a comparative study between this new protocol and our existing method, documenting our findings in our internal electronic lab notebooks and performance qualification templates. Given that this new bead-based method is faster and compatible with automation, it attracted interest from other PBMC processing laboratories within our network.
We invited interested parties to our laboratory and shared our comparative data. While effective, this approach was repetitive, time-consuming, and limited to local groups who could make on-site visits. To streamline this process and broaden our reach, we submitted our method and representative data to the Journal of Visualized Experiments (JOVE), with our journal selection criteria being open access and ideally offering a video of the protocol. Our manuscript was accepted in July 2024 (1) and the laboratory protocol was filmed in August. Not only is this open access material now accessible to any interested PBMC processing laboratory, it can also be utilised as an internal and external training resource, improving efficiency in our laboratory procedures.
The lack of validated, published biospecimen processing protocols is a significant gap in our field. By sharing our experience at NSWHSB, from performance qualification to publication, we hope to inspire other biobanks to publish their methods. This would enhance transparency and standardization, benefiting the broader scientific community.
(1) Villalva, M., Macphail, S., Li, Y., Caruana, B. Isolating Human Peripheral Blood Mononuclear Cells from Buffy Coats via High Throughput Immunomagnetic Bead Separation. J. Vis. Exp. (209), e66887, doi:10.3791/66887 (2024).)