Important Considerations For Implementing A Single-Use Biomanufacturing Strategy

By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC

Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. Increasing developments of biosimilars are also leading to fragmentation and dispersion of manufacturing capacity. Changes on the supply-side through technological advances have resulted in higher titers, enhanced specificity and better down-stream yields, reducing the need for large, expensive, dedicated developments have brought the culture volume needs into the realm of single-use systems for a large number of biopharmaceuticals.

Biomanufacturers are increasingly recognizing the advantages of single-use systems, which include: improved quality, safety from cross-contamination, flexibility, productivity, and time savings. For Gallus these advantages have allowed single-use systems to deliver improved cost efficiency along with:

• 50% reduction in capital cost
• 50% faster build-out of new manufacturing suites
• 80-90% reduction in clean water and steam use
• Reduced operating labor per unit of output