The Global Emergence of Single Use

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Adoption of single-use manufacturing continues to expand globally and is showing no signs of slowing down. And why should it? The biopharmaceutical industry is challenged to produce safe, effective therapies and vaccines amid the constant pressure to lower cost per dose in addressing healthcare needs of not only the western hemisphere, but emerging markets as well. To meet these challenges, manufacturers are turning to single-use and hybrid systems that incorporate a balance of stainless and single-use equipment. Over the past decade, single use has grown from an upstream tool used mainly by biotechnology companies in early stage drug development and experimentation (allowing them to fail fast) into a broadly deployed downstream therapeutic and vaccine manufacturing platform. Single-use technology is being adopted by drug manufacturers around the globe.

In response to the deadly Ebola outbreak in West Africa during 2014, industry leaders GlaxoSmithKline and Merck & Company used disposables as a pivotal part of their development and manufacturing strategies to speed new vaccines to market. Rapid response is critical when an outbreak has the potential to become a global epidemic.

Speed to market also is a strategic consideration as the industry assesses the best ways to develop and introduce biosimilars. By 2020, tens of billions of dollars worth of biologics will have come off patent. As those original products approach that steepening patent cliff, successful biosimilar manufacturers will align themselves closely with core benefits of single-use technology. Those include lower facility-build costs, flexible manufacturing, cost-effective multidrug production, and a sustainable platform with lower energy and water requirements.

What trends and hot topics are we seeing as manufacturers incorporate more single-use technologies into their current good manufacturing practice (CGMP) commercial operations? We hear about “factory-of-the-future” concepts, often similar to what Amgen has built in Singapore. Such manufacturing platforms have the flexibility and efficiency to drive down the average cost per gram of protein to meet evolving opportunities in the Asian market.

Whether it is such a facility or a hybrid plant, another trend with increasing popularity is modular system designs that drive greater standardization of single-use subassemblies to simplify production processes, shorten lead-times, and reduce stockkeeping units (SKUs) to streamline supply chain requirements. When modular subassembly concepts are combined with closed-system designs, even greater benefits can be realized. Amgen’s Singapore facility uses closed, modular system designs within ballroom-manufacturing suites that support production of multiple drugs in a single suite without risk of cross contamination.

Risk mitigation of closed systems further enables reduction of capital and operating costs with declassification of production clean rooms. For example, Amgen is leveraging closed-system processing in its Singapore facility to produce drug products in an ISO Class 9 controlled environment. If modular and closed-system designs are not enough, technology advancements are aiding the transition from batch production to continuous processing, which promises to further reduce the cost of manufacturing a gram of protein by over 50 percent.

In spite of all advancements during the past decade, we still face ongoing challenges in implementation and adoption of single-use technologies. These include addressing issues of extractables, particulates, system integrity, change control, supply-chain assurance/transparency, qualified workforce, technology gaps, and accelerating knowledge transfer and understanding of the new technologies to the many regulatory bodies. It will take a number of initiatives from across the industry to drive continuous improvement in innovation, standardization, and education to meet these challenges. No single supplier, drug manufacturer, technical organization, trade association, standards committee, or regulatory body will overcome all these varied challenges by itself. Collaboration will be key to our continued success as an industry. The great news is that many organizations and companies are dedicated to driving those solutions.

Reaching consensus on best practices is not always easy, and it can be time consuming. But we have a number of recent and ongoing efforts that prove it can be done for the betterment of the industry. In 2015, BPSA published its Component Quality Test Matrices Guide — updated by a cross section of users and suppliers to help guide users in selecting, qualifying, and validating single-use products. Similar work is ongoing within BPSA toward a particulates guide, and the organization is exploring guidelines for system integrity.

The benefits of collaboration are clearly evident within two active initiatives in which BPOG and BPSA are working together to drive common understanding and standardization in change control and user requirements. The list could go on, with activities under way among PDA, ISPE, ASTM E55, ASME-BPE, USP, XR360, and other organizations. Many have a strong cross pollination of members throughout the user and supplier communities that work within those organizations.

Collaborations targeted at resolving industry challenges will continue to accelerate the trend toward global adoption of CGMP commercial production facilities that leverage modular and closed-system designs as well as continuous processing based on single-use technologies. This is a very exciting time to be in our industry. It is a privilege to contribute to the evolving roadmap of how single-use technologies will help companies produce cost-effective therapies and vaccines that save and enhance the lives of patients in existing and emerging markets.

John Boehm is chairman of the Bio-Process Systems Alliance (BPSA) and bioprocessing business unit manager for CPC (Colder Products Company), a Dover Company; 1-651-603-2537; john.boehm@cpcworldwide.com; www.cpcworldwide.com.

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