Process Industry: Biomanufacturing made smarter

With the biopharmaceutical market undergoing continual and rapid change, larger, more traditional manufacturers face a number of key challenges, and are adapting their operations quickly.  For example, there has been a rise in the utilisation of specialist contract manufacturing to manage different capacity and specific requirements.

In addition, the ability to manufacture on a smaller scale for personalised batches means companies are needing to increase flexibility in plant operations. They are seeking a more modularised manufacturing set-up that keeps production times short, enhances fluidity to change from one product batch to another quickly, and reduces the complexity associated with validation and sign off.

For many, this shift in demand has seen pharmaceutical manufacturers employ smarter, and more innovative manufacturing methods. These include continuous mammalian cell culture, single-use systems, with increased use of simulation and automation technologies, all of which fall under the Smart Biomanufacturing umbrella.

Smart Biomanufacturing is focused on continually improving processes. With so many challenges within the sector, manufacturers need to work smarter to unlock efficiency gains, while offering more routes for innovation through fast scale-up from R&D to patient delivery.

With small and large scale pharmaceutical manufacturers focusing on the efficiency and flexibility of processes, continuous manufacturing and single-use systems are the growing trend. To further complement these manufacturing techniques, Siemens has recently partnered with a number of industry-leading suppliers of continuous and single-use systems, to provide technology solutions which enable processes to be tightly controlled, and also increase plant flexibility whilst integrating seamlessly with existing manufacturing processes.

Intelligent control of bio-reactors or fermentors using SIMATIC PCS 7 from Siemens provides real-time data, allowing manufacturers to have increased visibility of their processes to support the simplification of validation and qualification of these systems, directly at the point of operation.

When biopharmaceutical manufacturing takes place within a single-use environment, this can significantly reduce the costs and challenges that are typically associated with set up, contamination, cleaning and process validation.

In terms of efficiency, it is a big challenge to maintain the economy of scale. The challenge here focuses on the requirement to be able to harness the same yield and efficiency when manufacturing on a smaller scale. And with smaller reactors needed for personalised medicine and clinical trials batches, it isn’t viable for manufacturers to produce these medicines at a significantly greater cost than mass-produced medicines. For example, when manufacturing on a smaller, individualised scale, where volumes may be as little as 10 litres for personalised medicine, these smaller reactors ideally need to offer the same economies of scale as a single 5,000-litre reactor.

There is no doubt that the immediate future of biomanufacturing is small scale, smart and flexible manufacturing systems and processes.

Biopharmaceutical manufacturers are realising the benefits modular systems and processes bring to their operations.  ‘Plug and Play’ flexible systems that are quick to configure, scale up and relocate is the growing trend. Siemens has developed open interfaces which have the ability for the remote IO to be recognised on the network wherever it is plugged in and connected; providing visibility of what’s on the network and where it is. This allows manufacturers the flexibility to quickly adapt to changes in manufacturing demand and scheduling, with decisions made using real process intelligence.

Furthermore, technology within process control systems enables the routing of assets to gain network identification and increased efficiency. Siemens provides a broad portfolio of products and solutions to assist innovation in biomanufacturing. These are based around increased automation and digitalisation of the complex and innovative processes tools such as Electronic Batch Records (eBR), Process Analytical Technology (PAT), and Digital Twin Simulation.

Of course, with the increase in connected devices, biopharmaceutical manufacturers are now finding themselves in a position where they have increased volumes of data at their fingertips. This usable and intelligent real-time data offers increased visibility and traceability of the process to operators, which ultimately delivers enhanced control of the many complex and often interdependent manufacturing systems. Within this arena, Siemens’ MindSphere IoT operating platform seamlessly allows for the transfer of data between systems in real-time.

The market change and the number of new drugs continually being developed means Smart Biomanufacturing is playing an important role in helping businesses meet demand, while also continuing to drive bottom lines. Pharmaceutical companies are transforming their manufacturing processes, utilising digital technology, not only within existing operations, but also in the development and design of new greenfield sites.

To further aid their offering within the sector, Siemens also partners alongside a number of industry bodies including The National Institute for Bioprocessing Research and Training (NIBRT) in Ireland.  Forums such as NIBRT allow for the facilitation of best practice to drive and enhance industry innovation.  Furthermore, NIBRT offers access to industry-leading technology including the Siemens’ automation and digitalisation portfolio of solutions.  Companies can access single-use, small-scale pilot plant demonstrators’ to better understand how digital technologies and automation can be effectively deployed.

Ultimately, Smart Biomanufacturing is all about making continuous improvements and utilising intelligent data to provide innovative solutions.

In an industry which is continually developing, Smart Biomanufacturing offers pharmaceutical businesses the flexibility, control and cost-effective processes required to respond effectively to these market changes.