Scale-Out Biomanufacturing – A Paradigm Change to Scale-Up – Summary of Webinar provided by Dr. Jie Chen, Vice President of CMC Management
Changes to product demand require flexible and fast manufacturing scale adaptation. Increases in product demand could be caused by the addition of more indications, good post commercial results, marketing efforts, etc. Decrease in product demand can be caused by release of competitive products or the introduction of a biosimilar product. If product demand increases, bioreactor volume must be increased and/or additional bioreactor runs must be added. If demand decreases, then the problem is even larger, as manufactures may be in an overproduction scenario or significant time and resource investment will be required in scaling down. Additionally, some drug companies may be contractually bound to produce or pay for production they do not need.
There have been conflicting reports about the future of the blockbuster drug scenario. However, with cell culture productivity improvements and more specialized drug targets, many new products are not requiring the traditional 10,000-15,000 liter bioreactor production scale in order to meet customer demand.
With the heightened interest in personalized medicine as well as growth in orphan drug applications, more multi-product facilities are emerging. Not to mention the increase in outsourced manufacturing to CMOs that consistently run multiple products through their facilities. In these multi-product facilities, single use technologies enable faster turnaround time between runs with fewer cleaning and validation requirements.
A Scale-Out Approach
Dr. Jie Chen, Vice President of CMC Management, WuXi Biologics presented an interesting webinar on the advantages of scale out biomanufacturing. The webinar, “Evaluation of the Scale-out Biomanufacturing Strategy from Early Clinical Stage to Commercialization,” covered the advantages of a scale-out strategy vs. a scale-up strategy. Key advantages include:
- Enables single-use bioreactor technology to replace traditional stainless steel, fixed-tank bioreactors in commercial manufacturing plants
- Reduces product quality and process performance scale-up risks
- Flexible process design and validation strategies
- Accommodates a wide range of product levels and market demands
Dr. Chen began the presentation by discussing how the biomanufacturing industry landscape has evolved. It has shifted away from large scale 10,000-20,000 liter stainless steel tank bioreactors in fixed or single-product facilities for “blockbuster” drugs. Today’s “new era” of biomanufacturing facility is designed for flexibility to accommodate diverse product types and changing market demand dynamics, in addition to addressing pressures to control product costs. This is particularly true for Contract Manufacturing Organizations (CMOs), which must meet many different manufacturing demands derived from their biopharmaceutical industry clients.
Scale out is particularly well suited for a CMO. The scale out strategy provides an easy answer for facility fitness to a wide-range of products with different productivity and market demands. And a scale-out facility utilizing single-use disposable systems also provides better cross-contamination controls for multi-product manufacture while shortening the time and decreasing the cost of cleaning between different product production campaigns.