By Günter Jagschies, senior director of strategic customer relations, GE Healthcare
The biopharmaceutical industry is witnessing a shift toward “flexible” manufacturing. Businesses start with just ideas and perhaps one product in the pipeline and no product in market. In this initial high-risk phase, it is important to form the foundation of flexibility, the understanding of the product, and the establishment of the process. Once pilot-scale manufacturing appears on the horizon, the investment that is required must consider flexibility for the time when the business succeeds and matures and thus gets busier. But do all of us know what we mean by “flexible”? I want to explore the term and show how a greater appreciation of it can reap huge benefits for any company, from reducing capital expenditure to increasing agility in the marketplace.
Numerous economic and technical influences have brought us to the point of wanting greater flexibility in manufacturing, but there is no single approach to achieving the “right” level of flexibility. It depends on both production requirements and a company’s corporate culture, and, therefore, has to take into account philosophical, economic, and technical considerations. Originally, flexibility was strongly linked to single-use (disposable) systems for a particular operation/procedure/campaign, but it is now a more complex proposition, linking many elements connected with new and established technologies, facility design, staffing levels, regulatory framework, cost, and the political climate. A company will know when it has a “flexible facility” when it can accommodate the next surprise, such as a change in campaign or demand for a specific product, without a redesign.
Flexibility in biomanufacturing can mean manufacturing various products simultaneously or the ability to switch between campaigns easily and quickly. The highest demand for flexibility occurs in the non-GMP phase of a busy pilot plant, but for more established businesses, with several clinical projects ongoing in parallel, this may even be true for GMP manufacturing supporting trials. Typically, there is much less and a different type of flexibility demand in late-stage clinical trial support and the manufacturing of marketed products. At these stages, flexibility becomes more related to changes in scheduling than to the number of molecules and projects. Flexibility requires the design of processes that can be reconfigured or the ability to provide a wider range of options to produce drugs in the same facility that use different scales, technology platforms, and upstream and downstream processes. Making preclinical or clinical and commercial batches in the same facility also has different quality and compliance requirements.
The Impact Of Single-Use
Single-use equipment offers a way to improve flexibility over fixed stainless- steel installations, including traditional mono-facilities built to produce large volumes of a blockbuster drug. The choice between stainless steel and single- use is influenced not just by the economics of producing a batch size and the cost of goods, but also by the speed by which processes can be configured and operations started. These factors take operational flexibility to a new height, offering a choice when capital investment is at considerable risk because a biotherapeutic has not yet been approved or a marketing forecast changes.
The ability to install capacity that matches a company’s product forecast with closer certainty is very valuable. One such approach involves implementing new flexible factory platforms and modules that will accelerate biomanufacturing capacity while lowering risk, increasing speed, and reducing capital costs. These modules enable the deployment of new production capabilities in 9 to 18 months (versus 3 to 5 years for approaches used routinely today) at a total cost of less than 50 to 80 percent of conventional plants. They offer a solution that enables a gradual ramp up of capacity and which also readily supports localized manufacturing in emerging markets.
In conclusion, it is important to consider how flexibility can benefit the organization at all stages of the company’s development and those of its pipeline and products. This article has highlighted factors to consider and weigh in the drive to incorporate and benefit from flexible manufacturing for today and for tomorrow.