Author Archives: Robert Shaw

eBook: Buffers — Navigating New Demands on Downstream Raw Materials

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Bioreactor titers for monoclonal antibody (MAb) processes have increased significantly since the dawn of the biopharmaceutical industry, yet such gains have instigated bottlenecks for critical high-volume raw materials used in downstream processing, such as buffer solutions. As downstream purification is required for most, if not all, biopharmaceutical products, buffers and their preparation are topics that concern nearly every drug company. But those topics rarely receive direct attention. This BPI eBook explores what factors prompted the current buffer bottleneck and what…

March 31, 2021

Business Model Considerations for Development of Cell Therapies

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The cell therapy industry continues to make progress, as measured by increasing numbers of clinical trials and patients treated (1). Although discussions of the differences between “off-the-shelf†(allogeneic) and “patient-specific†(autologous and matched allogeneic) therapies continue, we are confident that both will find success. The best way to approach development for a cell therapy product is to consider these three fundamental drivers that guide development: Speed to market (Which pathway will allow for fastest access to the commercial market?) Operational…

April 1, 2014

Scale-Up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in Single-Use Bioreactors

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Mesenchymal stem cells (MSCs) are an attractive target for clinical study as therapeutic agents. However, current multilayer flatbed culture-expansion paradigms are cumbersome, time consuming, and typically limited in the ability to monitor cell characteristics during the growth process. We have used the Mobius® CellReady 3-L bioreactor in combination with microcarriers and human mesenchymal stem cells (hMSC) as a model. Following expansion, we have comprehensively compared the characteristics of cells grown in the bioreactor with those grown in standard two-dimensional (2D)…

August 1, 2013

Stem-Cell–Based Therapies

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A recent review of therapeutics in clinical development revealed 68 stem cell-based approaches (1). The majority of those leverage a patient’s own hematopoietic stem cells; others are exploring use of mesenchymal, neural, or embryonic stem cells. Here I highlight new therapeutic applications of stem cells and explore advances in the areas of induced pluripotent stem cells (iPS cells) and process-scale production of stem cells. Both should create new opportunities for stem cell-based therapies. Types of Stem Cells Hematopoietic stem cell…

March 1, 2011

Industrializing Stem Cell Production

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Stem cells have potential as a readily available, consistent source of many differentiated cell types. This unique property can be leveraged both for therapeutic purposes and for facilitating and improving a number of drug discovery and development processes. Large-scale, “industrialized” production of human stem cells in tightly controlled conditions will be required to deliver the quantity and quality of cells needed to support clinical trials and drug discovery development activities (Figure 1). Achieving this level of production while meeting rigorous…

October 1, 2010