Good Manufacturing Practice-grade fibronectin for hollow-fiber bioreactor cell manufacture: a mesenchymal stromal cell case study.

Background Aims: The need for large-scale production of mesenchymal stromal cell (MSC)-based cellular therapeutics continues to grow around the globe. Manual cell expansion processes can be highly variable between operators, require significant hands-on time from skilled staff and, because of the large number of open manipulation steps required to produce cells in dose-relevant quantities, be prone to greater risk of contamination relative to automated processes. All of these can increase overall production costs and risks to the patient.

An optimized HEK293T cell expansion protocol using a hollow-fiber bioreactor system.

Viral vectors are commonly used to introduce genetic material into cells to modify cell function for a variety of purposes. Manufacture of those modified viruses may use a variety of cell types to generate high titers of viral particles; one of the most common being HEK293 cells. These cells have been modified into different lines aimed at satisfying specific use cases.

The monoculture of cord-blood-derived CD34 cells by an automated, membrane-based dynamic perfusion system with a novel cytokine cocktail.

Human leukocyte antigen (HLA)-matched cord blood (CB) transplantation is a procedure for the treatment of certain hematological malignancies, hemoglobinopathies, and autoimmune disorders. However, one of the challenges is to provide a sufficient number of T cell-depleted hematopoietic stem and progenitor cells. Currently, only 4%-5% of the CB units stored in CB banks contain enough CD34 cells for engrafting 70-kg patients.

Stem-like memory T cells are generated during hollow fiber perfusion-based expansion and enriched after cryopreservation in an automated modular cell therapy manufacturing process.

Background Aims: Modular automation is a flexible and reliable option to build the foundation of a new or evolving process or to introduce automation to a process that is already established. Herein the authors demonstrate that modular automation provides both high-quality and high-yield T-cell products.

Methods: Cells from three individual donors collected on an automated continuous flow centrifugation system were successfully expanded in a functionally closed, automated, perfusion-based hollow fiber bioreactor.

An infrared 3D scanning device as a novel limb volume measurement tool in breast cancer patients.

Background: Lymphedema is a common complication of breast cancer treatment that affects one in five breast cancer survivors, yet there is no reliable method to detect lymphedema in the subclinical range. The objective of this study was to determine the feasibility and reliability of using an infrared 3D scanning device (ISD) as a peri-operative limb volume measurement tool.

Methods: Fifteen patients were analyzed based on inclusion criteria.

Assessing Arm Volume in People During and After Treatment for Breast Cancer: Reliability and Convergent Validity of the LymphaTech System.

Background: There are challenges related to the accurate and efficient measurement of lymphedema in people with breast cancer. The LymphaTech 3D Imaging System (LymphaTech, Atlanta, GA, USA) is a mobile, noninvasive platform that provides limb geometry measurements.

Objective: The objective of this study was to estimate the reliability and validity of the LymphaTech for measuring arm volume in the context of women seeking care in a specialty breast cancer rehabilitation clinic.

Monitoring Leg Lymphedema Over the Course of Therapy Using an Infrared System.

There are many techniques of monitoring leg lymphedema during physical therapy. Taking volumetric measurements with a tape measure is among the most common clinically, and changes in volume are typically used to measure therapy efficacy. This study shows how the Kinect infrared (IR) sensor with custom algorithms can assess leg circumferences and volumes comparable with tape measurements taken by a trained therapist while exploring regional leg changes to determine uniformity of change.

Evaluation of reagents used to coat the hollow-fiber bioreactor membrane of the Quantum® Cell Expansion System for the culture of human mesenchymal stem cells.

The addition of a coating reagent to promote cell adherence is necessary to prepare the membrane surface of the Quantum® Cell Expansion System hollow-fiber bioreactor for the culture of mesenchymal stem cells. In this study, the efficacy of 8 potential coating reagents has been compared in terms of the doubling times of their cell populations, cell morphology, characterization via flow cytometry, and capacity for trilineage differentiation. Human fibronectin (FN), pooled human cryoprecipitate (CPPT), and recombinant human vitronectin (VN) were successful as coating reagents, and each product has advantages in different cell culture contexts.

Genetic stability of bone marrow-derived human mesenchymal stromal cells in the Quantum System.

Background Aims: The Quantum® Cell Expansion System (Quantum; Terumo BCT, Inc, Lakewood, CO, USA) is a novel hollow fiber-based device that automates and closes the cell culture process, reducing labor intensive tasks such as manual cell culture feeding and harvesting. The manual cell selection and expansion processes for the production of clinical-scale quantities of bone marrow-derived human mesenchymal stromal cells (BM-hMSCs) have been successfully translated onto the Quantum platform previously. The formerly static, manual, in vitro process performed primarily on tissue culture polystyrene substrates may raise the question of whether BM-hMSCs cultured on a hollow fiber platform yields comparable cell quality.

Tampering by office-based methadone maintenance patients with methadone take home privileges: a pilot study.

Methadone Maintenance Treatment (MMT) is among the most widely studied treatments for opiate dependence with proven benefits for patients and society. When misused, however, methadone can also be lethal. The issue of methadone diversion is a major concern for all MMT programs.