Clinical Cell Processing News – part 4, 2016

by Alexey Bersenev on August 31, 2016 · 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.

Identification and validation of multiple cell surface markers of adipose-derived MSCs for GMP manufacturing (Stem Cell Res Ther) FREE

Our study establishes that clinical-grade AMSCs expanded in hPL represent a homogeneous cell culture population according to classical markers,. Additionally, we validated new biomarkers for further AMSC characterization that may provide novel information guiding the development of new release criteria.

1. A rapid sonication based method for preparation of stromal vascular fraction (Bioimpacts) FREE

The current protocol based on the sonication-mediated cavitation is a rapid, safe and cost-effective method, which is proposed for isolation of SVF and of course ADSCs cultures in a large scale for the clinical trials or therapeutic purposes.

2. Validation of Quantum Cell Expansion system for clinical-scale production of human periosteum derived stem cells (Cytotherapy):

The data show that the hollow fiber bioreactor is capable of robustly expanding autologous hPDCs on a clinical scale (yield between 316 million and 444 million cells starting from 20 million after ± 8 days of culture) while maintaining their in vitro quality attributes compared with the standard flask-based culture.

3. Protocol for GMP manufacturing of ADV-specific T-cells using G-Rex flasks (Cytotherapy):

Thirty-eight of 40 products (95%) met all release criteria. Median purity of the cell product was 88.3% CD3+ cells with a median yield of 2.9 × 107 CD3+ cells. Potency analyses showed a median ADV-specific interferon (IFN)γ response of 5.9% of CD3+ and 2345 IFNγ spot-forming cells/million.

4. Development of potency assay for immunomodulatory function of MSC (Immunol Lett):

The aims of this study were to develop an optimised rapid turnaround, flow cytometry-based whole-blood assay to monitor MSC potency and to validate its application to MSC immunomodulation. A protocol for short-term LPS stimulation of anti-coagulated whole blood samples followed by combined surface CD45/CD14 and intracellular TNF-α staining was initially developed for analysis on a 4 colour desktop cytometer.

5. A novel method for adipose-derived cell isolation with increased cell yield (Plast Reconstr Surg):

We have developed a protocol that maximizes the yield of ASCs derived from lipoaspirate. We demonstrate that NM-ASCs have increased osteogenic and adipogenic potential in vitro and are non-inferior to CM-ASCs in terms of their ability to generate bone and fat in vivo.

6. Feasibility of manufactturing CAR-CD171 cells for cell therapy of neuroblastoma (Clin Cancer Res)

Manufacturing of lentivirally transduced CD4+ and CD8+ CE7-CAR T cell products under GMP was successful in 4 out of 5 consecutively enrolled neuroblastoma patients in a phase I study. All four CE7-CAR T cell products demonstrated in vitro and in vivo anti-tumor activity. Conclusion: Our preclinical assessment of the CE7 epitope on CD171 supports its utility and safety as a CAR T cell target for neuroblastoma immunotherapy.

7. Clinical-scale production of T-regs from ALS patients (Cytotherapy)

In vitro expansion of Tregs for 4 weeks in the presence of GMP-grade anti-CD3/CD28 beads, interleukin (IL)-2 and rapamcyin resulted in a 25- to 200-fold increase in their number and restored their immunoregulatory activity. Collectively, our data facilitate and support the implementation of clinical trials of adoptive therapy with ex vivo expanded and highly suppressive Tregs in patients with ALS.

8. Validation of MyStem EVO kit for cell purification of the fluid portion of lipospirates (Plast Reconstr Surg):

The alternative procedures enabled comparable yields; the kit rapidly isolated lipoaspirate fluid comprising a homogenous cell population with adipose stem cell immunophenotype, bilineage potential, and efficient osteoinductive and angioinductive features.

9. Review: Scalable microcarrier-based manufacturing of mesenchymal stem/stromal cells (J Biotechnol)

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