March 2011 Supplement

Meeting the Challenges in Manufacturing Autologous Cellular Therapies

Personalized medicine is a promising new approach to disease treatment. The ultimate in personalized medicine is a cellular therapy manufactured specifically for an individual patient using his or her own cells. But this autologous approach to generating immunotherapies has unique manufacturing challenges. Each patient receives an individual product batch, which needs to be manufactured, tested, and released. So thousands to tens of thousands of batches could be made for each indication every year. Given the personalized nature of these therapies,…

Therapies of Tomorrow Require More Than Factories from the Past

Live cells are being incorporated as active agents and delivery vehicles for a broad range of emerging therapeutic strategies. Successful commercialization of a cell therapy requires more than proving its safety and efficacy to regulators. Ultimately a therapy must be commercially viable, allowing enough patients to be treated with an adequate financial margin to justify investment in it as a product. “Whether the cells used are universal (allogeneic) or patient-specific (autologous), it is unlikely to be wholly one or the…

Working Together for the Future

Most individuals who choose to pursue a career in healthcare would say they do so because they are driven by a fundamental desire to help people. If you ask people why they decided to work in the field of regenerative medicine, many will tell you it’s because they believe it is the most exciting area of medical research and that it holds the greatest potential to transform medicine as we know it. The transformational potential of stem cells and regenerative…

Technologies on the Cutting Edge

    On the brink of bringing exciting new therapies to commercialization, cell therapy developers are taking notice of how other companies are addressing processing and technical challenges. Here, leaders from Dendreon, Advanced BioHealing, and Pluristem describe their current cell therapy programs. And two organizations —the Alliance for Regenerative Medicine (ARM) and McLaughlin–Rotman Center for Global Health —provide details on the promises of regenerative medicine.   Cellular Immunotherapy   Dendreon’s Provenge (sipuleucel-T) cell therapy induces an immune response to aid…

Successful Commercialization Through Industry Collaboration

    Nearly a year ago, the International Society for Cell Therapies (ISCT) decided to integrate industry into its organization to build a stronger platform for commercializing therapies. Robert Deans, vice president of regenerative medicine at Athersys, was invited to serve as a leader of ISCT’s Industry Task Force, which aimed to identify industry roles in its organization. Within two months, the task force invited industry members and chartered a white paper (1) that described how ISCT should go forward.…

Stem-Cell–Based Therapies

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…

Opportunities in Regenerative Medicine

Capitol Hill fly-in days (see the last page of this issue) … A focus of Google Ventures (www.google.com/ventures) … A favored new investment arena for GE’s CEO Jeffrey Immelt, the recently named head of President Obama’s economic recovery advisory panel, and Life Technologies’ Greg Lucier … Hardly a day skipped without a major news publication covering some exciting aspect of the science … The provocative cover of Wired magazine’s (www.wired.com/magazine) November 2010 issue … It all sounds like the stuff…

Industry Educational Platforms Drive Commercialization Objectives

    Within the International Society for Cellular Therapy’s (ISCT’s) Industry Commercialization committee, Tracey Lodie, director of immunology and stem cell biology at Genzyme, chairs the Industry Education subcommittee, which was established in May 2010. In an interview with BPI, she described the subcommittee’s objectives and how they tie into the manufacturing, testing, and commercialization challenges for cellular therapies.   Reducing the Risk   “ISCT is working toward becoming an informational hub, acting as a resource to de-risk cell therapy…

Industry Roundtable

    With one eye on commercialization and the other on monitoring every-day challenges, cell therapy manufacturers are asking critical questions about process efficiency, ensuring quality, and satisfying regulatory demands. In this “virtual” roundtable discussion (participants were asked questions separately), cell therapy industry representatives answer key questions in hopes of broadening understanding about this new class of biopharmaceuticals. Participants in this roundtable are Timothy Fong, PhD (director cell therapy, Becton Dickinson Biosciences), Annemarie Moseley, PhD, MD (CEO, Repair Technologies), Firman…

Building a Bridge to Commercial Success

The history of the biopharmaceutical industry is one of continual invention and reinvention, of business models that have adapted to weather uncertain product futures and shifting economic fortunes. Some of us followed the up-and-down (and often financially painful) progress of monoclonal antibodies toward their eventual commercial success — a wealth of experience to draw from as other classes of products make their way from laboratories and onto the market. The vast majority of regenerative medicines are still produced at laboratory…