Expanded use of “plastic” manufacturing systems for commercial production of biotech products, as opposed to just clinical supplies, reflects broader acceptance and adoption of disposable alternatives to stainless-steel operations, according to attendees at the July 2014 annual summit of the Bio-Process Systems Alliance (BPSA) in Washington, D.C. Suppliers of single-use technologies components aim to support small biotech firms using single-use technologies for initial scale-up and late-stage trials, as well as larger manufacturers adopting single-use systems to meet expanded demand for new products more quickly.
Single-use technology adoption may be stymied, though, by a lack of standards that meet the needs of biotech manufacturers (end-users) as well as component suppliers. The use of single-use systems for larger, commercial operations, such as Amgen’s plan to use singe-use technology in its new Singapore facility, requires greater transparency regarding supplier changes in manufacturing processes and materials, which can affect the performance and quality of biotech production systems. Manufacturers attending the BPSA conference emphasized the importance of suppliers adopting GMPs and controls, and raised concerns about particulates and extractable and leachables related to materials used in single-use technology components. There was much discussion about ensuring a robust supply chain for key supplies and the need for proper disposal of used single-use bags and other items to prevent the release of bioactive waste.
Building a facility based on single-use technology is “very cost effective,” noted Mark Bamforth, president and CEO of contract manufacturer Gallus Biopharmaceuticals. A traditional biotech production operation takes five years to build and qualify, he explained, while single-use systems can emerge faster to support product launch and to “right size” future production. Single-use systems also are well suited for process development, which can involve multiple manufacturing changes; for clinical supply production, particularly with a continued 60% failure rate for Phase II clinical studies; and for producing innovative biotech therapies, such as autologous cellular therapy for regenerative medicine. A number of manufacturers are constructing hybrid systems, Bamforth noted, with stainless-steel bioreactors and certain single-use operations.
BPSA is developing a template for quality agreements between suppliers and end users to facilitate discussion of specific needs, support productive negotiations, and avoid disputes. The supplier organization also is finalizing recommendations for testing, evaluation, and control of particulates in single-use technologies with an eye to reducing problems and promoting particle control.
Industry organizations also are collaborating on these issues. ASTM International is drafting standards for testing single-use systems and for characterizing particulate burden and extractables. International Society for Pharmaceutical Engineering members are working on a single-use technology guide to address system design methods, extractable/leachable assessment, and disposal practices. The Parenteral Drug Association (PDA) is finalizing a technical report on best practices and basic requirements for single-use systems. And the BioPhorum Operations Group extractables team aims to publish a paper clarifying user requirements for suppliers with an eye to fostering more collaboration on such key issues as change notification, particulate testing and GMP adoption.