Tissue engineering is a multidisciplinary science that applies principles from engineering to the biological sciences to create replacement tissues from their cellular components (1). Resulting neotissues can repair or replace native tissues that are diseased, damaged, or congenitally absent. One technique that has come into widespread use is based on seeding cells onto a three-dimensional (3D) biodegradable scaffold that functions as a cell-delivery vehicle (2). Cells attach to the scaffold, which then provides space for neotissue formation and can serve…
“Single-Use Technologies”
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,…
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…
Managing Contamination Risk While Maintaining Quality in Cell-Therapy Manufacturing
With an increasing number of cell therapies becoming available for patient use, the need for controlled and consistent manufacturing and delivery of cell products is increasingly important. A closed cell culture process not only offers control and consistency, but may also relieve labor demands. Single-use components within a closed process also can reduce contamination risk. Closed systems with single-use platforms may reduce the risk of biological contamination and cross-contamination that could inadvertently be introduced into cell-culture processes. Such contaminants use…
Automation of Cell Therapy Biomanufacturing
Biomanufacturing automation is an established mission-critical step in the commercialization pathway for conventional therapeutics, including small molecules and monoclonal antibodies (MAbs) (1). The prospect of a potential biologic progressing into late-stage clinical trials without a robust biomanufacturing strategy to support at least pilot-plant scale bioprocessing is simply unthinkable. Conversely, the cell therapy industry (or at least a significant proportion of it) regard this as a trend that is unlikely to be mirrored as the industry develops. The aim of this…
Single-Use Technologies in Cell Therapy
Single-use technologies (SUTs) are tools that can be used in producing cell therapies and personalized medicines. Such products must meet specific requirements because of the way they are used. To meet those criteria, the cell therapy industry simply has no alternatives to single-use systems. SUT applications are rapidly changing. Traditional uses for single-use systems in cell therapy include processing in clinical settings (e.g., blood bags, transfer sets) and research and development (e.g., T-flasks, pipettes). Although such applications continue, the commercialization…
Vendor Voices: Flexible Manufacturing
One strong take-away message from BPI’s flexible facilities supplement (December 2012) is that there is no single road to achieving a flexible manufacturing process. The ability to quickly modify a unit operation, process line, or entire facility to accommodate change certainly depends on several factors. Flexibility is no longer exclusively linked to single-use systems for one specific operation. It connects facility design, staffing models, and revamped technologies. Vendors and suppliers are hearing first-hand what the industry wants in flexible operations.…
Evaluation of a New Single-Use UV Sensor for Protein A Capture
As the adoption of single-use systems continues to expand beyond bags and tubing to complete process steps, a full range of sensing technologies will be needed to complement the resulting varied single-use applications. Single-use sensors must meet or exceed the performance of traditional sensing technologies in areas such as accuracy, response time, ease of use, control system integration, process compatibility, regulatory requirements, and cost. Single-use flow-through process sensors are currently available for pressure, temperature, flow, and conductivity. Here, we report…
Vertical Integration of Disposables in Biopharmaceutical Drug Substance Manufacturing
Single-use (disposable) technologies are gaining significant traction in biopharmaceutical manufacturing due to reductions in capital investment for plant construction, lower requirements for cleaning and sterilization, and the advantages of eliminating cross-contamination during multiproduct manufacturing (1,2,3,4). In the early days of disposables, single-use (SU) systems were used only in specific unit operations (5, 6). Recently, however, options have become more widely available throughout drug-substance manufacturing (7,8,9,10). Companies now focus on selecting the right SU technology from an array of…
The Maturation of Single-Use Applications
“Learn from yesterday, live for today, hope for tomorrow. The important thing is not to stop questioning.†—Albert Einstein Single-use systems (SUSs) have been treated as novel technologies for some time. I have spent much of the past 10 years introducing clients to SUSs and integrating them into conventional processes. They are part of the biopharmaceutical development and production landscape and a mature, integrated option for bioprocessing. The value of SUS integration is soundly substantiated: reduced cross-contamination risk…