Single 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…

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…

Multiproduct Facility Design and Control for Biologics

    Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans. A Chemistry, Manufacturing, and Controls (CMC) Strategy forum was held in Bethesda, MD, in August 2011 to highlight various challenges, risks, and control strategies associated with multiproduct facilities. Multiproduct strategies for the manufacture of a…

Toward Flexible Hybrid Facilities of the Future

    As the bioprocessing industry has shifted away from traditional stainless steel bioreactors and vessels toward single-use technology, a new breed of manufacturing facilities has arisen. Flexible facilities take full advantage of traditional multiuse technologies and combine them with increasingly popular single-use technologies, offering an ability to mitigate risk and decrease manufacturing timelines. Although some companies have made the choice to remain strictly traditional (multiple use) and others have moved fully into single use, the flexible hybrid format gives…

Establishing Strategic Supplier Partnerships to Facilitate Manufacturing Success

    In November 2009, Talecris Biotherapeutics announced an ambitious US$269 million expansion of its Clayton, NC, manufacturing facility. The company was subsequently purchased by Grifols, Inc. in 2011. Constructing a new facility with a state-of-the-art manufacturing process intended to generate clinical products involves top-notch project management, exceptional fortitude, and numerous supply chain decisions. Suppliers are often relied on to provide standard product support. When used effectively, they can be an invaluable resource beyond basic services. Additional support may include…

Implementing a Fully Disposable MAb Manufacturing Facility

    Biopharmaceutical contract services have seen some very important changes and growth in recent years, part of an increasing trend toward outsourcing by pharmaceutical companies both large and small. And we have seen a significant change in the types of services demanded by clients. In addition to typical services such as validation, analytical services, and training, for example, demand has increased for outsourcing of process development, mammalian cell culture, good manufacturing practice (GMP) production, and final formulation and filling.…

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…

Outlooks on Standardization

    The Friday workshop of the 2011 BPI Conference in November may have been titled “Industrialization of Single-Use Manufacturing Technologies,” but in the discussion afterward, the mainly end-user audience zeroed in on an on-going debate in single-use implementation: standardization. Comments and questions echoed the current opinions, most of which were well known to the all-supplier panel and others present. To follow up on this discussion, I spoke with members of that panel because — as one expert put it…

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…

Single-Use Technology Supports Follow-On Biologics

    Follow-on biologics (FOBs, or biosimilars) differ from generic small-molecule compounds and pioneer biopharmaceuticals in several ways. Those differences affect aspects of their regulatory approval pathway, analytics, and marketing (1). Many biological active pharmaceutical ingredients (APIs) are actually incompletely characterized dynamic mixtures of macromolecules with slightly different primary compositions or higher-order structure (microheterogeneity). Those properties of macromolecules (unlike small molecules) are greatly influenced by their individual manufacturing process. Emerging regulatory guidelines for follow-on biologics are clarifying aspects of their…