Shifting downstream manufacturing from batch to continuous is a popular discussion topic in the world of biopharmaceuticals. Batch-centered manufacturing works, just look at the state of the industry today. Yet, as insufficient access to medicines and skyrocketing costs persist, there is much room for improvement – increased speed to market, improved and maintained quality, reduced footprint and diminished costs, to name a few. Continuous manufacturing is already in use in other industries like oil and paper as the most efficient means of manufacturing to meet the needs of the market. Why hasn’t it already been more widely adopted by the bio-pharmaceuticals industry?
The answers vary, but often include regulatory, technical, quality and validation concerns. These are not unfounded. Some of the technology required to enable fully continuous processing on a commercial scale is still in the process of being sculpted from an idea into reality. At the same time, new process technology is developed faster than regulatory bodies can handle. Still, we are further along than we let ourselves believe. Next generation sensors, simulated moving bed processes, in-line dilution and other systems are already on the market to allow us to start implementing continuous manufacturing.
Single-use technologies provide the essential building-blocks for continuous manufacturing to take off. Take ARTeSYN flow control modules – the disposable, precise flow control the modules provide enables the manufacturer to enhance the efficiency of its manufacturing. These components, paired with other emerging single-use technologies, are accelerating the move to continuous manufacturing day by day. Pharma solutions providers in today´s world are collaborating and colliding on a whole new level. All in all, our concerns may be valid, but they are exaggerated. It´s time to take a closer look at single-use and bring the “continuous future“ closer to reality.
By Liis Oblikas and Michael Gagne