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.
Validation of closed system automated device (CliniMACS Prodigy) for clinical expansion of NK cells (Cytotherapy) FREE
Automatically and manually produced NK cells were comparable in target cell lysis, degranulation and production of interferon-γ and tumor necrosis factor-α and had similar high levels of antibody-dependent cellular cytotoxicity against rituximab-treated leukemic cells. NK cells after automated or manual expansion showed similar gene expression and marker profiles.
Pharmaceutical grade xeno-free cell culture supplement as serum replacement for MSC culture (Stem Cell Res Ther) FREE
The tested human plasma-derived SCC sustains the adequate growth of hMSCs, while preserving their differentiation capacity. SCC can be a potential candidate for cell culture supplement in advanced cell therapies.
The CCS protocol on Prodigy is unrestrictedly functional. It runs fully automatically beyond set-up and thus markedly reduces labour. The quality of the products generated is similar to products generated with CliniMACS Plus. The automatic system is thus suitable for routine clinical application.
2. CliniMACS Prodigy validation for CD34 selection from HPC-A products (Cytotherapy) FREE
The process for CD34 selection with Prodigy is robust and labor-saving but not time-saving. Compared with clinical CD34+ selected products concurrently generated with the predecessor technology, product properties, importantly including CD34+ cell recovery and T-cell contents, were not significantly different. The automatic system is suitable for routine clinical application.
3. Feasibility of CultiSpher®-G microcarriers for MSC expansion (Cell Tiss Res)
We showed that the hHF-MSCs seeded at various densities quickly adhered to and proliferated well on the microspheres, thus generating at least hundreds of millions of hHF-MSCs on 1 g of CultiSpher®-G within 12 days. This resulted in a cumulative cell expansion of greater than 26-fold.
4. Viability and apoptosis assessment of cryopreserved cord blood units (Transfusion)
Postthawing cell viability determined by flow cytometric methods was in the following order: TNCs < MNCs < CD34+ cells. CD34+ cell viability was nearly identical to that of fresh CB 48 hours after collection. Necrosis or apoptosis in cryopreserved CB units did not accelerate during storage.
5. Quantitation of residual trypsin in cell-based therapeutics (J Immunol Meth)
It was demonstrated that an extended range of antigen quantitation could be achieved that covered nearly three orders of magnitude of trypsin concentration. The utility of the assay was demonstrated by its application to samples generated in a cell-based therapeutic manufacturing setting.
These results demonstrated a simpler GMP-compliant method of manufacturing an effective individualized DC vaccine. Such DC vaccine, when in combination with checkpoint inhibition therapies, might provide higher specificity against melanoma.
7. Expansion of MSC on Pall SoloHill® Microcarriers (GEN) FREE
Graft quality affects clinical outcome. Patients receiving grafts with inferior quality had more aGVHD and higher TRM. There is a need for better analyses for assessing graft quality in routine HSCT care; analysis using 7AAD on fresh PBSC grafts is not sufficient.
9. Assessment of CMV-specific CTLs function isolated from HPC-A products (J Transl Med)
CMV-specific CTLs can be efficiently isolated from G-CSF mobilized samples with Streptamers and are able to express activation markers and produce cytokines in response to antigenic stimulation. However, this anti-viral functionality is moderately reduced when compared to non-mobilized products.
10. Filtration of hematopoietic products – YES or NO? (Transfusion)
In the first phase, there was no difference seen in any markers of viability or potency for products after routine filtration. Based on those results, routine filtration was implemented. There was no difference in neutrophil or PLT engraftment. Thus, in this study, routine filtration did not impact the number of viable stem cells and did not delay engraftment.
New products on the market:
Cell Thawing Media (BioLife Solutions)
CytoSMART™ System for real time monitoring of cell health in culture (Lonza)
CryoPod™ – Liquid nitrogen based carrier (BioCision)
Clinical trial to watch:
Impact of DMSO concentration (5%, 7.5% and 10%) on engraftment after auto- HSC transplantation