"Reduction of risk, ease of use, reduced validation requirements, better process economics, faster campaign turnaround times and disposability are benefits inherent in the adoption of single-use processing as compared to traditional capital-intensive systems," noted Ken Ott, BPSA executive director.
Ott particularly emphasized the importance of last year's decision by BPSA to begin accepting end-users of single-use systems into its membership ranks. Already companies such as Bristol-Myers Squibb, Dow Corning and Lonza have joined.
"The addition of end-users into the BPSA organization is ongoing, with the objective of establishing a safe harbor business-oriented information exchange opportunity between users and suppliers of single-use systems and components. Such a forum is intended to assist end users in navigating the steps to implementation of plastics-based manufacturing and to share best practices to optimize costs, validation, deployment, disposability and testing," he explained.
Meanwhile, Millipore, Billerica, Mass., was among several vendors using Interphex to launch single-use systems. The company describes its new Mobius FlexReady Solutions, which handle clarification, media and buffer preparation, tangential flow filtration and virus filtration (Figure 3), as significant because they allow manufacturers to readily convert to single-use technologies.
It all comes down to the systems engineering involved: ensuring that solutions are easy to assemble, install, operate and change-out, and have the modularity/configurability the market demands, notes Paul Chapman, vice president of downstream processing. "We are bringing the Mobius FlexReady Solutions to market because our customers want more operational flexibility — varied batch sizes, faster process times, more efficiency."
Figure 2. Barriers to disposables: Existing investments in durable assets pose
"We went from preliminary design concepts to launch in nine months. This is unheard of in our industry or any other industry for that matter," boasts Chapman. During development Millipore worked with several unnamed biotech companies.
Millipore's experiences in the last year echo findings of BioPlan's survey that almost every kind of disposable has broad market penetration now. Overall the disposables business is one of the company's fastest growing areas.
Overall, speed remains the key challenge in the disposables market. "Our customers and Millipore are like-minded. They need to bring more molecules to market faster and we develop the technologies that enable them and the industry to gain efficiencies by producing smaller batches in faster process times," he concludes.
ATMI LifeSciences, Minneapolis, Minn., used Interphex to launch the next generation of its Nucleo bioreactor. The new unit brings together the expertise of single-use-mixing expert Pierre Guerin, Mauze, France, and ATMI's know-how in ultra-clean films. The scalable Nucleo bioreactor reportedly minimizes stresses on anchorage-dependent cultures while achieving new levels in high-density cell line growth.
Colder Products, St. Paul, Minn., demonstrated its HFC39 quick-disconnect couplings that are specifically designed to prevent external organisms from entering through the connector into the flow path during disconnection. The plastic components are polysulfone and the seals are platinum-cured silicone.