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…
Single Use
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…
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…
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.…
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…
Implementing Custom Single-Use Solutions for Cell Therapy Production
Cellular therapy continues to expand and gain momentum, as evidenced by the growing number of companies and clinical trials in the field each year. Early potential therapies were developed solely by investigators without communication or input from manufacturing experts. That communication gap led to numerous setbacks as potential products were developed without roadmaps for feasible manufacturing scale-up (or scale-out). Contributions from members of the cell therapy community over the past few years have significantly improved the situation in the form…
Reducing the Environmental Impact of Single-Use Systems
Committed to sustainability, EMD Millipore is working to provide solutions for the life sciences industry. This commitment is driven by four global issues: climate protection, global health, clean water, and resource efficiency. The company is designing product and process improvements to address these challenges and meet customer expectations. Figure 1: () Life-cycle assessment (LCA) is one of the most rigorous tools we use to help us understand and quantify our products’ environmental impacts (Figure 1). This holistic,…