The way drugs and vaccines are produced is undergoing an unprecedented transformation enabled by connected, digitized and automated processes, fueled by data and machine learning. Borrowing from the term "industry 4.0", which represents the fourth evolution that has occurred in manufacturing, "bioprocessing 4.0" describes the technologies that will serve as the cornerstone for the biopharmaceutical facility of the future. The industry will leave behind paper-based bioprocessing, data silos, manual process control and equipment that cannot communicate with each other. In its place will be a next generation ecosystem of processes, seamlessly coupled with uninterrupted data acquisition and analysis.
Because of their remarkable potential to help bring new medicines to market faster - intensified, connected or continuous processing along with software automation and analytics have been identified by influential industry organizations, such as the BioPhorum Group, as a part of the roadmap for transforming biomanufacturing. In addition to accelerating time to market, this transformation will help position drug manufacturers for success as they face increasingly complex regulatory requirements, intense cost pressures, opportunities to expand into a growing number of new product classes and high development costs.
Two elements are foundational to bioprocessing 4.0: First, the adoption of high-performance, intensified processes, which increase flexibility, reduce the manufacturing footprint, and shorten the lead time to adapt and establish manufacturing assets. This approach enables the manufacturer to significantly mitigate the risk of uncertainty created by changes in capacity requirements. Process intensification will also decrease cycle time to produce and release product, facilitating an on-demand supply chain. Second, is the implementation of software and automation strategies interlaced with the intensified processes. These elements will converge on four C's — control, for advanced management of unit operations; connect, to intelligently integrate the process continuum using advanced yet standardized protocols and sensor technologies, collection, as it pertains to data and advanced analytics for rapid process insights; and collaboration, including remote support and cloud services.
Next Generation Technologies are the Linchpin
For some in the industry, bioprocessing 4.0 means a completely single-use manufacturing facility; others envision it as a fully connected and fully continuous process. From my perspective, the ultimate goal is the latter; but the true definition of next generation bioprocessing is the technologies that will get us there – which I consider as any technology, expendable, or system which significantly changes the existing biopharmaceutical manufacturing template to deliver higher productivity, increased manufacturing flexibility, increased speed, and reduced risk. The fact is that we need more flexible approaches to biopharma production and the evolution is underway with the intensification of specific unit operations. Today, manufacturing processes are being engineered to deliver higher productivity with continuous mode operations.
At a fundamental level, the future of bioprocessing begins with flexible, easily connected intensification blocks that enable a process to easily meet a particular customer's needs. Every customer will have different templates and different objectives, so it is incumbent on suppliers, like us, to have building blocks that can be seamlessly integrated, as well as operate independently of one another if needed.
Taking the First Step Towards Bioprocessing 4.0
As our collective progress towards the facility of the future concept gains traction, companies are exploring how to link operations, creating fully connected, fully continuous processes. Our advice to biomanufacturers is to have an idea of what you're trying to achieve and define the bottlenecks you are facing. Obtain a good understanding of what connecting processes means at the bench scale first, because addressing the challenges early on will make it easier when moving to larger scale.
Partnerships are also going to be essential as we move into this new generation of advanced bioprocessing. Suppliers, like my organization, have a central role to play since we are developing solutions to help manufacturers gain the greatest benefit from next generation bioprocessing and overcome challenges that come with this type of change. Each molecule and manufacturer is unique with different processing priorities. Collaborating with a vendor offering a wide portfolio of manufacturing options, coupled with deep technical expertise enables manufacturers to tailor processes to most effectively meet their needs and usher in the era of bioprocessing 4.0 and the facility of the future.