Cell Therapies

Characterization of Human Mesenchymal Stem Cells

Human mesenchymal stem cells (hMSCs) are a self-renewing population of adherent, multipotent progenitor cells that can differentiate into several lineages. The current definition of MSCs includes adherence to standard tissue culture plastic ware, expression of various surface antigens, and multilineage in vitro differentiation potential (osteogenic, chondrogenic, and adipogenic). hMSCs hold great promise as therapeutic agents because of their potential ability to replace damaged tissue and their immunomodulatory properties. Consequently, many clinical trials using hMSCs are currently under way in a…

Downstream Technology Landscape for Large-Scale Therapeutic Cell Processing

The cell therapy industry (CTI) is poised to grow rapidly over the next decade, treating millions of patients and generating annual revenues into the tens of billions of US dollars (1, 2). To meet that high-growth demand, large CTI system manufacturers (e.g., Corning, Nunc/Nalgene, and GE Healthcare) and leading contract manufacturing organizations (CMOs, such as Lonza) are developing and integrating new upstream technology platforms such as gas-permeable membranes and microcarrier-based bioreactors to significantly increase therapeutic cell culture productivity. As those…

Advocating an Evolution

In a 2006 report, the US Department of Health and Human Services hailed regenerative medicine as “the vanguard of 21st century healthcare” and “the first truly interdisciplinary field that utilizes and brings together nearly every field in science” (1). To fuel support for regulatory, legislative, and reimbursement initiatives in this new therapeutic class, a small group of scientists, life science business executives, patient advocates, and other experts formed the Alliance for Regenerative Medicine (ARM, http://alliancerm.org). Starting with 17 charter members,…

Culture of Normal Human Dermal Fibroblast Cells in a Functionally Closed Automated Cell Expansion System

The Quantum Cell Expansion System is a functionally closed and automated hollow-fiber bioreactor system that is designed to expand both adherent and suspension cells in a reproducible manner. The hollow-fiber membrane requires a coating agent to help facilitate cellular adherence when culturing an adherent cell type such as MSCs. Pooled human cryoprecipitate (CPPT, Bonfils Blood Center) was examined as an alternative to FN because it is a rich source of extracellular matrix components, including fibrinogen (Freedman, 2010), and also because…

Regenerative Medicine

    The year 2011 may be seen as one in which regenerative medicine entered its adolescence. Public attention — from investors to desperate patients — finally turned toward this nascent industry with something other than skepticism or unrealistic expectations. The FDA’s approval of Dendreon’s Provenge cellular immunotherapy switched on the spotlight, and cell therapy companies suddenly faced a barrage of questions about cost, manufacturing issues, product development, and patient access. US Policy: In May 2011, US representatives Brian Bilbray…

Cell Therapies Roundtable: Building the Pillars to Success

In order to deliver cell-based therapies on a commercial scale, cell therapy companies and suppliers must form partnerships in order to overcome existing manufacturing, regulatory, and analytical challenges. Four leading cell therapy experts discuss what is and what has to be done in order to accomplish this objective.