Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
By: Simon Chalk
There is a high degree of consensus in the biomanufacturing industry that product quality, customer service, and cost efficiency are fundamentals for success. Flexibility is another must-have attribute, and although everyone wants it, you're likely to get a wide spectrum of definitions when you ask what it is.
With such a diverse view on what flexibility means, the possibility of confusion and dissipated organizational focus is high. So what are the different meanings of flexibility and what is best practice for creating a clear vision that can be implemented?
For some, flexibility means the ability to switch between campaigns quickly and easily in a multiproduct facility or even to manufacture different products concurrently. The history of bioprocessing drug substances has been such that mono-facilities were built to produce large volumes of single blockbuster products. The business environment has changed and biofacilities now need to be capable of adopting a more diverse role. Many mono-facilities have been converted to multiproduct use. With shorter changeover times and faster clean-down routines, utilization increases and facilities become more responsive to demand signals.
Creating reconfigurable processes or providing a wider range of options to produce drugs in the same facility using different scales, technology platforms, and upstream and downstream flow balances can also exhibit greater flexibility. Making clinical and commercial batches in the same facility is an additional dimension of flexibility where greater deftness in application of quality policy and compliance is required. Many CMOs have become skilled at this and trade on their flexibility. Innovator firms are heading in the same direction.
STAINLESS STEEL VERSUS SINGLE USE
For many, the use of disposable or single-use equipment offers a route to enhanced flexibility that traditional stainless steel, fixed installations cannot. The choice between stainless steel and single use is influenced not just by the economics of batch size and cost of goods but also by the speed by which processes can be configured and started up. This takes operational flexibility to a different level and provides options when capital investment is at risk because of marketing forecast changes and approval uncertainty. Long construction and start-up lead times for stainless-steel plants have been an uncomfortable reality for the industry when demand volumes fail to materialize and new drugs have failed in the clinic. The ability to install capacity within a horizon of near certainty is a very valuable position to be in.