Clinical cell processing news – part 1

by Alexey Bersenev on May 9, 2012 · 1 comment

in cell separation, clinical lab

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In the new series of posts I’d like to review recent advances in clinical cell processing. In this series I’ll overview a literature and focus on some particular techniques.

1. Production and process of platelet lysate for MSC expansion (Cytotherapy) open access!
Fetal bovine serum replacement by platelet lysate (PL)

PL from whole blood-derived pooled platelet concentrates and apheresis platelet concentrates did not differ significantly in their growth-promoting activity on MSC.

2. Processing of mobilized blood products by counterflow centrifugal elutriation (Stem Cells TM) free full text upon registration

Our data demonstrate that, using standard elutriation procedures, >99% of red blood cells and platelets were removed from apheresis products with high recoveries of total white blood cells and enrichment of CD34+ cells in two of five fractions.
The processes were highly automated and closed from receipt of the apheresis product through formulation of target-enriched cell fractions. Thus, elutriation is a feasible method for the initial manipulations associated with primary blood cell therapy products and supports cGMP and current good tissue practice-compliant cell processing.

3. Sepax validation for bone marrow processing in cardiac cell therapy trial (Transfusion)

Although the Sepax procedure takes only 90 minutes, the total time for processing was approximately 7 hours. Contributing to this were incoming testing and device preparation, release testing, patient randomization, and product delivery.

4. Improvement of CD34+ cell enrichment from cord blood using CliniMACS (Cytotherapy)
Comparison of standard tubing set (TS) versus the larger capacity tubing set (LS):

… LS provided higher post-selection viability and more efficient recovery. In this case, a lower maximum TNC specification of TS was not predictive of better performance. The same may hold for smaller scale enrichment of other cell types with the CliniMACS instrument.

5. Validation of Sepax for adipose tissue processing (Tissue Engineering: Part C)

As compared with the manual process, automation resulted in a 62% higher isolation yield, with 2.6±1.2×105 nucleated cells per mL of liposuction, and a 24% higher frequency of clonogenic progenitors. The variability in the isolation yield and clonogenicity across different preparations was reduced by 18% and 50%, respectively.

Please let me know what do you think about this series.

{ 1 comment… read it below or add one }

Michael An May 10, 2012 at 3:13 pm

Any human blood-derived products possess real risk and high regulatory hurdle. Yes, they are being used if pass the available checks on several commonly-known pathogens. However, these tests are not comprehensive and not 100% accurate. The risk is amplified when using pooled blood for large scale production. Moreover, there is no way to check currently unknown or emerging pathogens for which no test is available. I don’t want to scare people, but no one can guarantee that another HIV-hemophilia saga won’t happen again.
I just don’t see any reason to retrogress to blood products while defined media are readily available.
Michael

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