Industry 4.0 – A Driver for Technology Innovation in Biotech

‌The toolbox of bioprocessing technologies available today offers choices for each unit operation in an end-to-end process. This toolbox includes stainless steel, single-use or continuous platforms that are commercially available from multiple suppliers and that are aligned to the outputs of commercially available production bioreactors both fed batch and/or perfusion. This equips the Process Development (PD) group with the opportunity to design new manufacturing processes selecting the most suitable technology for each unit operation to improve process efficiency and performance. Rather than go for a fully stainless steel or a fully single-use process a third option exists which is to mix up the technology platforms in a so-called hybrid approach.

The metaphor that we will describe aligns to a subway map where the passenger has multiple options to get from Station A to Station B and the route will be influenced by factors such as ease of connection, access with luggage, frequency of trains etc. It is the same thought processes that need to be considered when designing a new bioprocess. Factors such as scale of operation, operational flow rates, buffer storage, product stability etc. all will influence the selection of a specific unit operation in the downstream process.

The benefits of technology selection include improved facility utilization, optimized productivity, improved product quality all leading to enhanced patient safety, key drivers in the adoption of the practices underpinning Industry 4.0. As we progress along the journey we see that automation, control and data management are key aspects of future new hybrid bioprocesses. In-line or at-line analytics will support the drive to improve product quality and patient safety as well as overall facility throughput. There will be an increased use of virtual reality to design facility layout and optimize equipment usability and digital twins will be used to evaluate various hybrid production scenarios and create risk mitigation strategies.

In order to address the challenges faced as we move forward with the adoption of Industry 4.0 we have developed several new technologies and product platforms that supplement the existing toolboxes and are potential enablers for process improvement and optimization. These will be illustrated and demonstrate how it should be possible to develop process flows using the technology platforms best optimised for optimal productivity based on kg product produced per year per unit facility footprint. As new modalities such as gene therapeutics and exosomes progress further towards the clinic so these approaches to process design and development will become more and more standardized in order to enable products to get to market faster at the most appropriate cost.