Cell Therapies

Strategies for Microcarrier Culture Optimization

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…

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

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).

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

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…

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

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…

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

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).

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

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,…

Cell-line/Process Development – BPI Theater @ BIO 2015

Ray Price (senior director of business development, DiscoveRx) 3:30–3:55 pm Advances in Research Tools to Accelerate Drug Development Price introduced the BioSeek drug-discovery platform with examples. The technology is built on three pillars: primary human cells; models that use growth factors or cytokines to model a disease environment and then predict how drugs change biomarker responses in those systems; and comparisons of generated profiles with a reference database of more than 4,000 compounds. DiscoveRx uses that database and informatics tools…

Are You Ready for a Tech Transfer? Part 2: Overcoming Obstacles and Implementing Best Practices for Cell Therapy Technology Transfer

In part 1 of this two-part series, we outlined common challenges of technology transfer that are unique to the cell therapy industry and discussed strategies for success (1). Here, we delve even further into best practices and highlight key strategies for technology transfer that should be considered along the path to success. Creating a strong foundation for technology transfer will streamline clinical manufacturing processes and help position therapeutic products for long-term success. Below are key criteria for success. Confirm Transfer…

ISCT Special Report: Advancing Cell Therapy Manufacturing at the 2015 Annual Meeting

The International Society for Cellular Therapy (ISCT) will host its 21st Annual Meeting at Caesars Palace Hotel and Convention Center, Las Vegas, NV, 27–30 May 2015. More than 1,200 industry and regulatory professionals, clinicians, scientists, and laboratory professionals are expected to attend. The program covers six plenary sessions, six workshops, three technical sessions, and more than 20 total track sessions covering such topics as advances in cell therapy research, commercialization strategies, quality and operations, and regulatory issues. BPI spoke with…

Accelerating Affordable Growth: Careful Planning Can Pave the Way for Commercial-Scale Manufacturing

As this special issue of BioProcess International goes to press, an increasing number of cell-based therapies are advancing through preclinical investigation into clinical development and on toward commercialization. Although clinical efficacy will be the primary metric for product approval, the ability to manufacture these therapeutic products consistently, reliably, and cost-effectively will continue to be a key driver and predictor of commercial success. Several articles presented herein describe major issues and challenges facing developers of cell-based therapies. Although some of the…