Container system for enabling commercial production of cryopreserved cell therapy products.

08:18 EDT 28th March 2015 | BioPortfolio

Summary of "Container system for enabling commercial production of cryopreserved cell therapy products."

Aim: The expansion of cellular therapeutics will require large-scale manufacturing processes to expand and package cell products, which may not be feasible with current blood-banking bag technology. This study investigated the potential for freezing, storing and shipping cell therapy products using novel pharmaceutical-grade Crystal Zenith((R)) (CZ) plastic vials. Materials & methods: CZ vials (0.5, 5 and 30 ml volume) with several closure systems were filled with mesenchymal stem cells and stored at either -85 or -196 degrees C for 6 months. Vials were tested for their ability to maintain cell viability, proliferative and differentiation capacity, as well as durability and integrity utilizing a 1-m drop test. As controls, 2 ml polypropylene vials were investigated under the same conditions. Results: Post-thaw viability utilizing a dye exclusion assay was over 95% in all samples. Stored cells exhibited rapid recovery 2 h post-thaw and cultures were approximately 70% confluent within 5-7 days, consistent with nonfrozen controls and indicative of functional recovery. Doubling times were consistent over all vials. The doubling rate for cells from CZ vials were 2.14 +/- 0.83 days (1 week), 1.84 +/- 0.68 days (1 month) and 1.79 +/- 0.71 days (6 months), which were not significantly different compared with frozen and fresh controls. Cells recovered from the vials exhibited trilineage differentiation consistent with controls. As part of vial integrity via drop testing, no evidence of external damage was found on vial surfaces or on closure systems. Furthermore, the filled vials stored for 6 months were tested for container closure integrity. Vials removed from freezer conditions were transported to the test laboratory on dry ice and tested using pharmaceutical packaging tests, including dye ingress and microbial challenge. The results of all stoppered vials indicated container closure integrity with no failures. Conclusion: Pharmaceutical-grade plastic CZ vials, which are commercially used to package pharmaceutical products, are suitable for low-temperature storage and transport of mesenchymal stem cells, and are a scalable container system for commercial manufacturing and fill-finish operation of cell therapy products.


General BioTechnology, LLC, Indianapolis, IN, USA.

Journal Details

This article was published in the following journal.

Name: Regenerative medicine
ISSN: 1746-076X
Pages: 659-67


PubMed Articles [38415 Associated PubMed Articles listed on BioPortfolio]

Overview of Cell-Free Protein Synthesis: Historic Landmarks, Commercial Systems, and Expanding Applications.

During the early days of molecular biology, cell-free protein synthesis played an essential role in deciphering the genetic code and contributed to our understanding of translation of protein from mes...

Conservation and destruction of autologous and allogeneic cryopreserved cellular products: Recommendations from the SFGM-TC.

Thousands of autologous and at less extent allogeneic hematopoietic stem cells (HSC) bags are cryopreserved in France. The majority of autologous HSC grafts are used within a year after collection. Ho...

Radiosynthesis of 3-indolyl1-(11)Cacetic acid for phyto-PET-imaging: An improved production procedure and formulation method.

An improved production procedure and formulation method for the carbon-11 radiolabeled phytohormone, 3-indolyl-[l-(11)C]acetic acid ([(11)C]IAA), was developed by modifying selected original reaction ...

Segregation and phase inversion of strongly and weakly fluctuating Brownian particle mixtures and a chain of such particle mixtures in spherical containers.

We investigate the segregation pattern formation of strongly and weakly fluctuating Brownian particle mixtures confined in a three-dimensional spherical container. We consider systems where the partic...

3D printed drug/cell carrier enabling effective release of cyclosporin A for xenogeneic cell-based therapy.

Systemic administration of the immunosuppressive drug cyclosporin A (CsA) is frequently associated with a number of side effects; therefore, sometimes it cannot be applied in sufficient dosage after a...

Clinical Trials [6627 Associated Clinical Trials listed on BioPortfolio]

Experimental Human Malaria Infection by PfSPZ

Experimental human malaria infections are generally accepted to be a powerful tool for evaluation of potential malaria vaccine and drug efficacies. Until now, experimental infections have ...

Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers

The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC relativ...

Ziprasidone Pharmacokinetics Using a Reduced Food Effect Formulation Compared to Pharmacokinetics From Commercial Capsules

Commercial ziprasidone capsules show a large increase in bioavailability with food. The formulation tested in this study aims to reduce or eliminate that increase.

Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water

The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the sta...

Biological Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Peripheral stem cell transplantation combined with biological therapy ...

Medical and Biotech [MESH] Definitions

Compressed gases or vapors in a container which, upon release of pressure and expansion through a valve, carry another substance from the container. They are used for cosmetics, household cleaners, and so on. Examples are BUTANES; CARBON DIOXIDE; FLUOROCARBONS; NITROGEN; and PROPANE. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

A process in which peripheral blood is exposed in an extracorporeal flow system to photoactivated 8-methoxypsoralen (METHOXSALEN) and ultraviolet light - a procedure known as PUVA THERAPY. Photopheresis is at present a standard therapy for advanced cutaneous T-cell lymphoma; it shows promise in the treatment of autoimmune diseases.

Specialized cells of the hematopoietic system that have branch-like extensions. They are found throughout the lymphatic system, and in non-lymphoid tissues such as SKIN and the epithelia of the intestinal, respiratory, and reproductive tracts. They trap and process ANTIGENS, and present them to T-CELLS, thereby stimulating CELL-MEDIATED IMMUNITY. They are different from the non-hematopoietic FOLLICULAR DENDRITIC CELLS, which have a similar morphology and immune system function, but with respect to humoral immunity (ANTIBODY PRODUCTION).

Treatment using irradiation with LASER light of low power intensity so that the effects are not due to heat, as in LASER THERAPY. These non-thermal effects are thought to be mediated by a photochemical reaction that alters CELL MEMBRANE PERMEABILITY, leading to increased mRNA synthesis and CELL PROLIFERATION. Low-level laser therapy has been used for a wide variety of conditions, but most frequently for wound healing and pain control.

A fractionated cell extract that maintains a biological function. A subcellular fraction isolated by ultracentrifugation or other separation techniques must first be isolated so that a process can be studied free from all of the complex side reactions that occur in a cell. The cell-free system is therefore widely used in cell biology. (From Alberts et al., Molecular Biology of the Cell, 2d ed, p166)

Search BioPortfolio:

Relevant Topic

Stem Cells
Latest News Clinical Trials Research Drugs Reports Corporate
Track and monitor developments in stem cell research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on stem cells and follow companies active in the stem cell industry.  BioPort...


Searches Linking to this Article