Clinical cell processing news – part 6, 2015

by Alexey Bersenev on December 17, 2015 · 0 comments

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Clinical Cell Processing News is a series about new protocols, products and techniques for clinical-grade cell processing and manufacturing. Cell processing devices, cultureware, bioreactors, GMP-grade reagents, cell separation techniques. This series is posted every 2 months.

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Perspective: Use of ancillary materials in cell therapy manufacturing (Cytotherapy) FREE

The key message we wish to emphasize is that in order to most effectively mitigate risk around cell therapy development and patient safety, users must work with their suppliers and regulators to qualify each AM to assess source, purity, identity, safety, and suitability in a given application.

Packed bed bioreactor for expansion of placenta-derived MSC (PLoS ONE) FREE

We demonstrated that placental derived MSCs could be isolated directly within the bioreactor and subsequently expanded. Our results demonstrate that the closed system large-scale packed bed bioreactor is an effective and scalable tool for large-scale isolation and expansion of MSCs.

1. Validation of Spectra Optia for volume reduction and RBC depletion of bone marrow (Transfusion)

This study demonstrates that the Spectra Optia can effectively volume reduce and RBC deplete human BM before transplantation. Time in transit should be as short as possible but may be extended up to 24 hours if the donation is refrigerated during transit.

2. GMP-grade protocol for expansion of angiogenic CD34+ cells from HPC(A) products (Cytotherapy)

We successfully scaled up the expansion process with the use of culture bags because there is the need to move toward a dynamic and fully controlled bioreactor system to meet Good Manufacturing Practice (GMP) standards and attain clinically meaningful cell doses in a time- and cost-effective way.

3. Head-to-head comparison of CliniMACS Prodigy and CliniMACS Plus for CD34+ cells isolation (Transfusion)

CD34+ cells can be effectively selected from mobilized PBSC concentrates with the CliniMAC Prodigy, but the recovery of CD34+ cells and depletion of CD3+ cells was lower than with the semiautomated CliniMACS Plus Instrument.

4. Post-thaw recovery of lymphocyte subpopulations in cryopreserved apheresis products (ASH 2015, Abstract 4307)

G-CSF mobilization and longer liquid storage time do not impair post-thaw recovery of lymphocyte subpopulations when compared to products from non-mobilized donors. However there is a slight decrease of viability with longer liquid storage time. Our results further suggest that T lymphocytes exhibit a higher sensitivity toward freezing and thawing than B lymphocytes, which may have clinical implications for cellular therapies using frozen products.

5. Validation of BacT/ALERT for sterility testing of cord blood (Transfusion)

In Phase 1, bacteria failed to grow in CB units containing antibiotics. Thus, antibiotic-free units were used for the other phases. C. albicans was not always captured in plasma, but using a mix of RBCs and plasma, all organisms were detected. The use of pentastarch or hetastarch did not affect microbial recovery. C. albicans and A. brasiliensis were preferentially recovered in RBCs and BC. Cryopreservation did not affect microbial survival during CB processing.

6. Impact of duration and temperature of storage on cord blood cell viability (Clin Lab)

The temperature prior to processing has little yet sometimes significant effects on cell viability in stem cell concentrates prepared from cord blood. However, the absolute differences in cell viabilities are quite small. Therefore, the effect is clinically negligible in a range from 4 degrees C to 28 degrees C if cryopreservation is done within 48 hours.

7. Development of point-of-care HSC gene therapy platform (ASH 2015, Abstract 4307)

Current state-of-the-art requires ex vivo HSPC gene transfer in dedicated Good Manufacturing Practices (GMP) facility infrastructure, limiting treatment to highly developed countries. A patient point-of-care strategy would therefore make HSPC gene therapy available to patients worldwide. We developed a short, semi-automated, mostly-closed platform for ex vivo isolation and lentivirus (LV) gene modification of CD34+ HSPCs from either bone marrow or mobilized peripheral blood sources using the CliniMACS Prodigy.

8. Establishing of clinical Master Cell Bank and Working Cell Bank for umbilical cord Wharton’s jelly-derived MSC (Cytotherapy)

This works demonstrates the feasibility of the derivation and large-scale expansion of UC-MSCs from small and relatively old fragments of UC typically discarded from public cord blood banking programs.

9. Protocol for simultaneous measurement of human hematopoietic stem and progenitor cells subsets in blood by flow cytometry (Cytometry: part B)

The goal of this study is to simultaneously measure HSCs and HSPCs in normal human venous blood using multi-color flow cytometry. Our secondary aim is to determine how G-CSF mobilization alters the quantity of each HSC and HSPC population.

10. Depletion of allo- reactive T-cells by adenosine – GMP-compliant method to prevent GVHD in haploidentical stem cell transplant (ASH 2015, Abstract 380)

This novel SD technique employing adenosine as a pharmacological agent satisfies the requirements of allodepletion with preservation of viral and leukemia-specific immune responses and thus presents a potentially economical method to deplete alloreacting T cells in SCT products for clinical applications.

11. Comparison of different cryoprotectants for controlled rate freezing of Wharton’s Jelly-derived MSC (Int J Stem Cells) FREE

Although 10% DMSO has shown higher post-thaw cell viability compare to 10% PVP and cocktail solution, the present study indicates the feasibility of developing a well-defined DMSO free cryosolution which can improve storage and future broad range applications of WJMSCs in regenerative medicine without losing their basic stem cell characteristics.

12. Comparison of output from MarrowStim P.A.D. Kit versus ficoll bone marrow cell separation (Biores OA) FREE

CFU assays demonstrated that the MarrowStim P.A.D. Kit output a significantly greater number of mesenchymal stem cells and hematopoietic stem cells compared with cells output by Ficoll separation. There was no significant difference in the number of endothelial progenitor cells output by the two separation techniques.

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