Clinical Cell Processing News – part 5, 2015

by Alexey Bersenev on October 21, 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.

Video protocol: Enrichment of CMV-specific T cells for clinical applications using the cytokine-capture system (JoVE) FREE

Validation of CellEffic CB filter device for cord blood processing (Cell Prolif) FREE

Processing using the novel filter yielded high quality RBC depletion while maintaining good recovery of TNC, MNC, CD34+, HPCs and colony forming unit (CFU) output. The filter performed equally well using HES or SALINE. Gravity-led flow provided gentle cell movement and protection of the stem cell compartment. Post-thaw CFU output was maintained particularly, an important indicator for CB banking.

1. Validation of GentleMax for umbilical cord tissue dissociation and banking protocol (Transfusion)

In this study, we have established a reliable and standardized protocol to isolate UCT-MSCs from UCT for cell banking purposes. Processing the whole umbilical tissue with GMP-graded enzymes using a semiautomatic dissociator allowed us to obtain a single-cell suspension product with a known number of isolated cells that can be cryopreserved right after isolation and thawed as needed for expansion and clinical use.

2. Generation and flow cytometric quality control of clinical TCRαβ/CD19-depleted hematopoietic grafts (Cytometry B)

In clinical use this method may help to improve transplantation outcome, due to the correct application of the desired stem cell and the limited T cell dose. The panel is designed for the quality control following TCRαβ/CD19-depletion but is adaptable to other depletion strategies as well.

3. Analysis of quality control tests in GMP production of dendritic cells (Stem Cells TM) FREE

From 2010 to 2014, 54 patients were enrolled in the studies and 54 batches of DCs were prepared. We retrospectively analyzed the results of the quality control tests carried out on each produced batch, evaluating yield of mDCs and their quality in terms of microbiological safety and immunological efficacy.

4. Review: Manufacturing of dental pulp cell-based products from human third molars (Front Physiol) FREE

This article focuses on current manufacturing strategies of dental pulp cell-based medicinal products and proposes a new protocol to improve efficiency, reproducibility and safety of these strategies.

5. GMP protocol for generation of T-regs from leukapheresis (Cytotherapy)

Results suggest that functional CD25+ products can be isolated with a GMP-ready method, and good recovery can be obtained with the use of an optimized cryopreservation protocol. These data and methods show the potential, possibilities and future work needed to isolate target cell populations in a reproducible, time-efficient and cost-efficient manner for clinical applications.

6. Manufacture of clinical-grade human clonal MSC products (Tis Eng C)

We have previously developed an alternative isolation and culture protocol for establishing a population of clonal MSCs (cMSCs) from single colony forming unit (CFU)-derived colonies. In this study, we established a good manufacturing practice (GMP)-compatible procedure for the clinical-grade production of human bone marrow-derived cMSCs based on the subfractionation culturing method (SCM). We optimized the culture procedures to expand and obtain a clonal population of final MSC products from single CFU-derived colonies in a GMP facility.

7. Training practices of cell processing laboratory staff – AHCTA survey results (Cytotherapy)

Survey data showed the use of a variety of training and competency methods but some methods predominated, suggesting their utility. These results could help new and established facilities in making decisions for their own training and competency programs.

8. Special issues: Enabling Cell Therapy Manufacturing and Manufacturing Strategies for Regenerative Medicine Success (Bioprocess International supplements) FREE

9. New products on a market:
Serum Replacement for T-cell expansion – CTS Immune Cell SR (Gibco – Thermo Fisher) product
FDA DMF for PLUS™ Human Platelet Lysate (Compass Biomedical)

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