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,…
Search Results for: regenerative medicine
A Decade of Success
After nearly a year of planning, BPI announced the winners of its first awards program on the evening of 9 October 2012, during the BioProcess International Conference. Award finalists, sponsors, and guests joined us for a banquet ceremony in the Providence, RI, Convention Center to honor the 36 finalists for our Decade of BioProcess awards — and announce the 12 winners. In his welcoming comments to the 150 attendees, BPI publisher Brian Caine noted that “during this…
Global Marketplace
3D Bioreactor Product: InBreath whole-organ bioreactor Applications: Tissue engineering and regenerative medicine for trachea, esophagus, intestines, blood vessels, and other hollow, tubular organs Features: The autoclavable, GLP-compatible InBreath bioreactor is designed for cell seeding and culturing on intraluminal and extraluminal surfaces of a tubular matrix. A polymer culture chamber houses the scaffold and culture medium for the entire duration of organ generation. Secondary “paddle” elements move with the scaffold holder to mix the culture medium continuously for mass transport and…
Formulation and Delivery
Biopharmaceutical formulation and delivery are more than science; they also must take into account patient preferences and behavior, the biology of diseases being treated, and even the concerns of legal, sales, and marketing groups. But science is the foundation. Formulation work has become more methodical and quantifiable thanks to advancing analytical technologies — which brings quality by design (QbD) into formulation laboratories. The vast majority of biotherapeutics and vaccines are parenteral drugs — many of them lyophilized and…
Poster Presentations
Enhancing Manufacturing Development Efficiency Svetlana Dukleska (Merck) Early Research Stability Studies Can Aid in Rapid Screening of Potential Drug Candidates In a competitive research and development (R&D) space with tight time lines, it is important to have a toolbox of extended characterization and analytical assays for rapid screening of potential candidates. Additionally, early research stability studies can provide initial information on potential degradation pathways for screening candidates, for purification development, and for establishing stable formulations. Herein, we show…
Bioreactor Design and Bioprocess Controls for Industrialized Cell Processing
It’s official: The “Age of Cell Therapy” has arrived. A robust pipeline of cell therapies, with increasing numbers of both early- and late-stage clinical trials as well as FDA-approved commercial products that have entered the market already, strongly indicates that the cell therapy industry is poised to emerge as a distinct healthcare sector (1). Renewed investor interest and recent activity among major pharmaceutical companies suggest that this industry will rapidly develop the capability and capacity to be a highly competitive,…
A Decade of Product Development
In 2004, the United States Food and Drug Administration (FDA) transferred regulation of many highly purified, “well-characterized†biopharmaceutical proteins from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER), which until then had primarily regulated only synthetic, small-molecule drugs and chemical substances. The most novel/complex and the less-characterized biologics remained within CBER’s jurisdiction. This change complicated BPI’s mission somewhat. When the magazine was founded, we responded to questions from advertisers…
Designing the Ideal Bioreactor with Single-Use Technology
Bioprocessing companies are hoping for a brighter future in biologics manufacturing that will include ever-higher titers of vaccines and therapeutic proteins grown in cell culture. It would also facilitate bioprocess operations without the recurring challenges that stem from process scale-up and human error. Moreover, that future would also comply with increasingly stringent regulatory and current good manufacturing practice (CGMP) requirements while providing better cost controls than we see today. How far away is this future? Perhaps not too…
Improve Process Uniformity and Cell Viability in Cryopreservation
Cell therapies and related cell-based technologies constitute an emerging, fast-growing market with a total value expected to exceed US$100 billion by 2019 (1). Cell therapy is defined as the process of introducing cells to a patient’s tissue for disease treatment. These therapies generally require cryopreservation to maintain sufficient product quality and shelf life. As a common practice, cell therapy manufacturers use controlled-rate freezers to optimize cooling profiles. The goal is to preserve final products in cryopreservation media with the highest…
Emerging Challenges in Cell Therapy Manufacturing
The introduction of recombinant proteins and monoclonal antibody (MAb) products revolutionized the treatment of many diseases, including diabetes, rheumatoid arthritis, multiple sclerosis, Crohn’s disease, cardiac disease, and cancer. These highly specific biologic therapies provide patients with life- saving approaches that are not possible with small molecules. MAbs in particular are a unique class of biopharmaceutical products that interact with and activate components of the immune system to provide such therapeutic benefits as tumor destruction by antibody-dependent cell-mediated cytotoxicity…