Scale-Out Biomanufacturing

WuXi Biologics applies a scale-out instead of a scale-up strategy to achieve higher volume production scales (see images below).  Scale-out manufacturing offers more flexible manufacturing options especially in late-stage or commercial production scenarios.. Scale-out manufacturing utilizes multiple bioreactors run in parallel to produce late stage clinical material and market demand using the same size of bioreactor as used in early stage clinical trials. The advantages are numerous and include:

• Maintaining the same bioreactor size for cell culture manufacture between phases of development or market demand cycles means little risk to process and product quality as you increase your manufacturing volume requirements.
• Can develop design space and achieve high levels of process understanding very early in development making eventual validation effort faster and more efficient.
• An adverse event in a single bioreactor does not mean the production lot is lost.
• Lower upfront costs (capital investment) to establish facility and the facility can be operational and validated faster than traditional large scale bioreactor sites.
• Using disposables for production means faster changeover between manufacturing runs and lowers risks of contamination events.
• Utilize inherent advantages to single-use/disposable systems (risk reduction of contamination between runs in multi-product use facility).

Similar to the concept described above, WuXi Biologics utilizes small footprint, fully robotic and programmable, isolator-based fill systems to achieve a scale-out manufacturing strategy for drug product production. Scale-up risks are eliminated and flexible and adaptable production can be achieved as clinical or market demands change. In addition, the faster changeover between runs that can be achieved with these systems is another added benefit for multi-product and multi-use fill facilities.