Is Your Biobank Truly Functional? The Case for Independent PBMC Quality Audits
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At Accelevir, we focus on ultra-rare target detection and have become hyper-vigilant about incoming PBMC Quality which includes viability, recovery and Flow based immuno-profiling. As expected we find that PBMC quality is one of the most critical elements of end-point readouts and triage decisions for clinical trial design and outcome measurements.
Sponsors frequently discover—too late—that the “viable” cells in their biobank are functionally compromised. Our decade of experience has led us to understand not only the monetary loses due to poor PBMC recovery but subsequent delays in Clinical Studies , and often unusable datasets following expensive assays and readouts.
The “Black Box” of Biobanking
When a clinical site freezes a sample, many processing conditions can drastically affect interpretability. Variables include:
- The Isolation Method: Did the site use a standard Ficoll Density Gradient or a SepMate tube?
- The Freezing Rate: Was a Controlled-Rate Freezer used, or a Passive Freezing Container (Mr. Frosty)?
- The Medium: Are samples frozen in 10% DMSO + FBS or a Commercial Cryomedium?
According to best practices outlined by the International Society for Biological and Environmental Repositories (ISBER), standardization is critical. A sample might look fine immediately after thaw but fail to perform in complex downstream applications.
Introducing: The Independent PBMC Evaluation
To solve this, Accelevir is now pleased to offer comprehensive PBMC Processing & Functional Validation Services as a “turn-key” program that can be defined at your desired frequency.
Our indpendent PBMC assesment has enabled Sponsors to identify sites that might require further training and implement a independent Quality Assurance program to keep track of PBMC quality. This gives clinical operations teams a mechanism for onboarding new sites, training new operators or just having confidence that the input samples are meeting the intended standards.
Audit Your Bank Today Ensure your biobank is truly functional. Start your project by requesting a custom PBMC QC quote today to initiate your independent evaluation.
At Accelevir, we focus on ultra-rare target detection and have become hyper-vigilant about incoming PBMC Quality which includes viability, recovery and Flow based immuno-profiling. As expected we find that PBMC quality is one of the most critical elements of end-point readouts and triage decisions for clinical trial design and outcome measurements.
Sponsors frequently discover—too late—that the “viable” cells in their biobank are functionally compromised. Our decade of experience has led us to understand not only the monetary loses due to poor PBMC recovery but subsequent delays in Clinical Studies , and often unusable datasets following expensive assays and readouts.
The “Black Box” of Biobanking
When a clinical site freezes a sample, many processing conditions can drastically affect interpretability. Variables include:
- The Isolation Method: Did the site use a standard Ficoll Density Gradient or a SepMate tube?
- The Freezing Rate: Was a Controlled-Rate Freezer used, or a Passive Freezing Container (Mr. Frosty)?
- The Medium: Are samples frozen in 10% DMSO + FBS or a Commercial Cryomedium?
According to best practices outlined by the International Society for Biological and Environmental Repositories (ISBER), standardization is critical. A sample might look fine immediately after thaw but fail to perform in complex downstream applications.
Introducing: The Independent PBMC Evaluation
To solve this, Accelevir is now pleased to offer comprehensive PBMC Processing & Functional Validation Services as a “turn-key” program that can be defined at your desired frequency.
Our indpendent PBMC assesment has enabled Sponsors to identify sites that might require further training and implement a independent Quality Assurance program to keep track of PBMC quality. This gives clinical operations teams a mechanism for onboarding new sites, training new operators or just having confidence that the input samples are meeting the intended standards.
Audit Your Bank Today Ensure your biobank is truly functional. Start your project by requesting a custom PBMC QC quote today to initiate your independent evaluation.