Cell/Gene Therapies

Meeting Lot-Size Challenges of Manufacturing Adherent Cells for Therapy

by , , , and

Adherent cells such as adult primary cell lines and human multipotent (MSCs) and pluripotent stem cells (hPSCs) present a manufacturing challenge as lot sizes increase from 109 (billions) to 1012 (trillions) cells (1). Typically, manufacturing platforms are good for one log of expansion. So new methods will be required to achieve commercially relevant lot sizes. Traditional two-dimensional culture methods have been used to grow anchorage-dependent cell types. Although such methods are reliable and well defined, they are very labor intensive…

September 16, 2015

T-Cell Suspension Culture in a 24-Well Microbioreactor: High-Throughput Screening of Operating Conditions

by , and

Cell therapy promises revolutionary new therapeutic treatments for cancer and other serious diseases and injuries. For example, T-cell therapy response rates of >50% and durable complete response rates of 20% have been reported in patients with metastatic melanoma who had failed other therapies (1). In another example, sustained remissions of up to a year were achieved among a small group of advanced chronic lymphocytic leukemia patients upon treatment with autologous T-cells expressing an anti-CD19 chimeric antigen receptor (2). Numerous other…

September 16, 2015

Scaling Up Stem Cells: Moving from Laboratory to Commercial Production with a Single-Use Multiplate Bioreactor

by , and

Cell-based products are becoming increasingly important as potential biotherapies. Cell therapy is predicted to have a huge impact on the healthcare sector over the coming decades. Stem cells, in particular, are investigated as potential treatments for a diverse range of applications (such as heart disease and metabolic and inflammatory disorders) in which they might be used to restore lost biological functions. Read the full text of this article in the PDF (Login required).

September 16, 2015

Expansion and Characterization of Mesenchymal Stem Cells on Pall SoloHill® Microcarriers

by , and

Mesenchymal stem cells (MSCs) are self-renewing cells that differentiate into several terminally differentiated cell types. These cells have been isolated from multiple sources such as bone marrow, adipose tissue, peripheral blood, and other adult tissues(1–6). The interest in these cells is that they hold the potential to cure disease and are being pursued in clinical trials. Three emerging fields of interest for stem cells are cell therapy, regenerative medicine and screening of candidate drugs. In many cases, poor correlation between…

September 16, 2015

Strategies for Microcarrier Culture Optimization

by and

The process of delivering an allogeneic stem-cell therapy to patients requires isolation and expansion of rare tissue-specific stem cells, which are subsequently delivered to individual patients for treatment. One type of cell used for such therapies is commonly known as human mesenchymal stem cells (hMSCs). They have been isolated from a number of tissues: e.g., bone marrow, heart, brain, placenta, and umbilical cord. And they have been shown to be immune-privileged in that hMSCs elicit no graft-versus-host (GvH) response such…

September 16, 2015

Designing the Most Cost-Effective Manufacturing Strategy for Allogeneic Cell-Based Therapies

by , and

Rapid progress is occurring in the field of stem cell therapy research, and increasing numbers of products will begin reaching the market in the near future. But new cell therapy treatments must fit into a competitive and highly regulated healthcare environment. Succeeding in that environment requires alignment between a company’s business model and its manufacturing strategy. Read the full text of this article in the PDF (Login required).

September 16, 2015

Production of Viral Vectors Using the iCELLis® Fixed-Bed Bioreactor System: Beyond Mesenchymal Stem Cells — Gene-Modified Cell Therapy, Gene Therapy, and Exosomes

by

In the past few years, the resurgence of cell-based immunotherapies — and, by extension, gene therapies — has accelerated as products move rapidly from academic research laboratories into commercial development. A successful clinical trial by St. Jude Children’s Research and the University College London of a gene therapy for hemophilia B was a seminal translational event (1), as was the licensing of the University of Pennsylvania’s gene-modified chimeric antigen receptor T-cell technology (CAR-T) for leukemia by Novartis (2). CAR-T cells…

September 16, 2015

Single-Use Bioreactors and Microcarriers: Scalable Technology for Cell-Based Therapies

by , , and

Cell-based therapies hold promise for treating many acute and chronic diseases (1). Optimism surrounding that therapeutic potential has driven the initiation of multiple clinical trials in pursuit of such treatments. Procedures for preparing these therapeutic agents begin with selective isolation of cells from desired tissues. That is followed by ex vivo expansion of cells of desired phenotype and functionality. Once expanded to acceptable levels, cells are stored to preserve their viability during transportation to treatment facilities. The final step in…

September 16, 2015

Ask the Experts: Core Technologies Expand Opportunities for Cell Therapy Manufacturing

by

Pall Life Sciences has long been known for its expertise in processing and filtration equipment for the biopharmaceutical industry. In recent years, the company has broadened its offerings in upstream manufacturing by expanding its core capabilities in the single-use, bioreactor, and microcarrier arenas, with unique and innovative technologies for cultivation of cells to be used as therapies. Read the full text of this article in the PDF (Login required).

September 16, 2015

Positioning Tools, Technologies, and Talents for Cell Therapies: An Interview with Harvey Brandwein

by

On 12 March 2015, BPI publisher Brian Caine and editor in chief Anne Montgomery spoke with Harvey Brandwein, Pall’s vice president of business development, at the company’s Port Washington, NY, facility. Pall’s director of marketing for cell therapies, Alain Fairbank, also provided her thoughts on the evolution of tools and technologies for this market sector. Knowing that this interview would become one of the concluding chapters in Pall’s special issue with BPI, we reviewed a number of topics covered earlier,…

September 16, 2015