Interview with Andrew Whytock | Siemens

ACHEMA Inspire: Digitalisation could be an acceleration factor. How digitalised is the pharma industry right now?

• __Andrew Whytock: Digitalisation can indeed help accelerate the development process as well as manufacturing. These two areas should be considered separately and then as a whole. The recent pandemic efforts have highlighted that: manufacture and development had been progressing in small silos, each digitalised to some extent in its own environment, but with few connections between them. For example, the BioNTech case, which accelerated collaboration during development and then set an ambition for a digitalised production process, using software and automation tools manage the process in their new plant in Marburg. Siemens was instrumental in setting up the new process in less than five months. Like in many pharma plants there are still many manual steps, especially in preparation and transformation, so always further potential to optimise, automate and digitise. Considering the process as a whole and digitalising the entire value chain will make a genuine improvement.

ACHEMA Inspire: Siemens talks about an end-to-end Digital Enterprise Solution – what is your approach as far as the pharma industry is concerned?

• __Andrew Whytock: Our comprehensive approach covers the real and virtual worlds of product, process and production. It can start with product and process design, through simulation and modelling to software, moving to manufacturing and supply chain, often supported though cloud-based analytics and applications. This can be in active ingredient manufacture (primary processing) and manufacturing the formulated product itself (secondary processing). We have a number of software applications and solutions in our portfolio, and the common element is to make use of a virtual or digital environment to get better understanding and/or efficiency in the real world, which is the concept of a digital twin.

ACHEMA Inspire: What are the benefits of a digital twin implementation?

• __Andrew Whytock: Every day, millions of vaccines doses are being produced: makers are turning to digitalisation to speed things up. Working with our project partners, we are planning to introduce digital twins of the entire vaccine manufacturing process for all future vaccines and could also have application in our vaccines’ development activities.

  In other words, twins of the product, productions, and performance will be linked. These offer high added value in biological processes, or where elements like physical models have to be better understood, as in the vaccination process. This would improve monitoring and control over all processes. The principle of “co-simulation” is key: Twins of individual part-processes are created first – from cell culture fermentation to purification, the specific formular, and the filling process, all of which will be combined at a later stage.

ACHEMA Inspire: Which of your software solutions realise a digital twin?

• __Andrew Whytock: Using mechanical models and artificial intelligence (AI), we developed a hybrid model to simulate and monitor the process. The critical process parameters we identified were concentration and temperature in the feed tanks for the phospholipids, the flow volume in both feed tanks, and the flow volume ratio. Besides the size if the adjuvant’s particles, a determining factor in their quality is the quantity of the active pharmaceutical ingredient (API) they can transport. Both qualities can be monitored using process analytical technology (PAT): Near infrared spectroscopy (NIR) looks at chemical concentration (API=, and dynamic light scattering (DLS) measures size. The resulting digital twin of the process is therefore based on simulation, AI, automation, and PAT.

ACHEMA Inspire: In pharma, industrial software solutions will be the future. Could you elaborate the role you thin it will play?

• __Andrew Whytock: The concept of the digital enterprise applies to all industries. In our industry, quality is key and the cost of ensuring quality is high, especially when the large number of manual processes is taken into account. Automation brings some benefit but a MES system, sich as our Opcenter Execution Pharma, enables paperless manufacturing and is a platform that helps to be faster.

  And we are also developing specific Pharma Apps that leverage the data that is collected throughout the process to further enable batch release by exception and in real time. For the MRNA production in BioNTech there are over 50,000 different manufacturing steps in a batch that need to be recorded and reviewed. Digital solutions not only help us to reduce the review time, but also pick up potential errors that avoid reword and waste.