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.
GMP-compliant protocol for rapid generation of antiviral T-cells (J Transl Med) FREE
The generation of antiviral CD4+ and CD8+ T cells by CliniMACS CCS can be extended to a broad spectrum of common pathogen-derived peptide pools in single or multiple applications to facilitate and enhance the efficacy of adoptive T-cell immunotherapy.
How to deal with critical reagent shortages in stem cell lab (Telegraft) FREE
The shortage of critical reagents utilized for the processing of cellular therapy products creates a challenging situation for Cellular Therapy Facilities. Most recently, we have encountered the shortages of Dextran, Normosol-R and Plasma-Lyte A, creating technically challenging and stressful situations for cellular therapy facilities without qualified sources for critical reagents.
Review: Towards a commercial process for the manufacture of genetically modified T cells (Cancer Gene Ther) FREE
A decentralized manufacturing model is proposed, where in the future patients’ cells could be processed at the point-of-care in the hospital.
1. Minimal quality requirements for clinical cultures of MSC (Stem Cells Dev)
The objective of this document is to provide the minimal quality requirements for the MSC production and its delivery for clinical use, so that the safety of the final cell therapy product will not be compromised. For this purpose, the document evaluates the most important steps of GMP-compliant MSC production…
2. Impact of cord blood processing methods on transplantation outcomes (Biol Blood Marrow Transplant)
In conclusion, CBB processing has no significant effect on early (day 100) survival despite differences in kinetics of neutrophil recovery.
Our data indicate that bacterial 16S rDNA PCR is a useful alternative for rapid sterility testing, not only for blood products used in transfusion medicine but also for stem-cell products used in regenerative medicine.
This study indicates that post-thawed UCB HPCs are preserved for less than 30 minutes at room temperature; thus, the optimal length of time of cryopreserved cord blood infusion should be no more than 20 minutes after thawing.
The combination of CD3 and CD28 with IL-7 and IL-15 gave the best balance of CAR T-cell expansion and potent GD2-specific effector functions while retaining a stem/memory phenotype, and these growth conditions will therefore be used to manufacture CAR T cells for our phase I clinical trial.
In conclusion, XN-2000 can provide more accurate HPC-related data than XE-2100, providing more accurate information to clinicians in terms of the timing of stem cell collection for SCT.
7. Plasma-depleted versus red cell-reduced umbilical cord blood (Cell Transplant) FREE
These findings suggest that PD units not only have more TNCs, CD34+ cells, and CFU than RCR units but also have high engraftment rates and may be more effective for treating certain conditions such as β-thalassemia.
8. A protocol for manufacture of CAR T-cells using the Sleeping Beauty system (Cancer Gene Ther)
Here, we outline our approach to nonviral gene transfer using the Sleeping Beauty system and the selective propagation of CD19-specific CAR+ T cells on AaPCs.
Increased cell concentrations in CB do not limit the recovery of CD34-positive leukocytes nor the viability of leukocytes or the number of CFUs after thawing. On the contrary, CB units with high cell concentrations show a better outcome than units with low cell concentrations. Only RBCs seem to have a negative influence on CB quality.
We proved that human blood components are suitable substitution for FCS in cultivation media for long-term DPSC cultivation.