Single-Use Technologies in Production

Single-use systems (SUS) are revolutionizing biologics production by offering flexible, scalable, and contamination-resistant solutions for upstream and downstream processes. This approach significantly reduces cleaning validation, cross-contamination risks, and downtime between batches. With growing pressure to accelerate time-to-market while maintaining compliance, single-use bioreactors, mixers, filters, and tubing assemblies have become industry standards for both clinical and commercial production. The ability to swiftly adapt production scale and switch between multiple products enhances efficiency in multi-modal manufacturing environments. Topics include design optimization, extractables and leachables (E&L) testing, supply chain reliability, and cost-benefit analyses compared to stainless steel systems. As regulatory agencies begin issuing specific guidance on SUS, validation and lifecycle management are becoming critical considerations. Innovations in automation, modular facilities, and hybrid systems are further expanding the utility of SUS in biologics and biosimilar manufacturing. Industry leaders attending this track will gain practical insights into maximizing productivity while ensuring compliance, sustainability, and scalability in today’s fast-paced production landscape.

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