Validation of the MacoPress SMART for Volume Reduction of Cord Blood Units at Héma-Québec’s Cord Blood Bank
Bibliographic record
Abstract
Cord blood (CB) dedicated for long-term storage is volume reduced prior to cryopreservation. One benefit of volume reduction is the reduction of costs related to storage space. Cord blood volume reduction also increases the security of the products by significantly reducing the number of red blood cells (RBCs) and the amount of dimethyl sulfoxide (DMSO) needed to protect stem cells from cryopreservation. Since the beginning of the operations at Héma-Québec’s cord blood bank (CBB) in 2005, the “top and bottom” blood extractor Optipress (Baxter Healthcare, Deerfield, IL, USA) has been used for CB volume reduction. Because the Optipress will no longer be supported by the supplier, the MacoPress SMART (MacoPharma, Tourcoing, France) was first tested by our applied research group to make sure that it could meet, after cord blood volume reduction, predetermined technical specifications such as consistency in the volume obtained (24 ± 2 ml), total nucleated cell count (TNC) recovery (≥60%), and hematocrit (≤0.5 l/l). The objective of this work was to perform a process validation after the completion of the installation qualification and operation qualification of the MacoPress SMART. Cord blood was collected in utero according to Héma-Québec CBB procedure after obtaining consent from donating mothers. On the basis of the binomial probabilities, it was established that 60 cord blood units (CBUs) had to be processed to meet the predetermined satisfactory level of confidence. To process 60 CBUs with the shortest delay possible, both qualified and nonqualified CBUs were used. After processing and quality control analysis, nonqualified CBUs were discarded and qualified units were electronically blocked to prevent any possible release from quarantine until the approval of the report. Table 1 summarizes the results of the validation. Performance of the MacoPress SMART (n = 60) All cord blood units exhibited post-thaw colony-forming unit growth. Abbreviations: SD, standard deviation; TNC, total nucleated cell count. Validation results show that the MacoPress SMART consistently produced CBUs within the specified volume range, hematocrit, TNC, and viable CD34+ recoveries and RBC percentage reduction. All CBUs met viability specifications and exhibited post-thaw potency. Thus, the MacoPress SMART was implemented into our operations.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.013 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".