FRESH PERSPECTIVES
Implementing a Single-Use Biomanufacturing Strategy: Important Considerations
Jodi M. Zobrist and
Nicole W. O’Brien, Ph.D. Gallus Biopharmaceuticals, LLC
Implementation of a Single-Use Biomanufacturing Strategy
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 specifi city and better downstream yields, reducing the need for large, expensive, dedicated, and infl exible stainless steel based facilities. These technological 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, fl exibility, productivity, and time savings. For Gallus Biopharma, these advantages have allowed single-use systems to deliver improved cost effi ciency 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
It should be noted that SU systems do have higher raw material and disposal costs; however, they bring a high degree of fl exibility to the manufacturing process. This fl exibility allows rapid product change- over with minimal risk to product integrity. It is also possible to readily change total manufacturing volume by simply increasing or decreasing in the number or size of SU reactors used in a campaign.
This paper provides an overview of the process used at Gallus BioPharmaceuticals, a cGMP contract manufacturer of mammalian cell biologics, to select and implement a SU biomanufacturing strategy and why the GE FlexFactory platform was chosen as the best solution.
As an experienced contract manufacturing organization (CMO) Gallus needs to be able to deliver the right amount of manufacturing capacity to its clients, either via a “pay per batch” approach or via virtual ownership of capacity (SuiteSPACE™ Model), as well as being able to operate a clinical services suite (CSS) according to cGMP standards, and accommodate all types of early-phase mammalian cell culture processes and products. The need for such fl exibility made the decision to use a SU manufacturing system the obvious choice. The challenge was in selecting the right system.
47 American Pharmaceutical Review | Fresh Perspectives 2013 Figure 1
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