Enterprise Recipe Management
A faster time to market
Maria Grahm, Head of Vertical Pharma, Siemens AG
Is there a way to speed up the development and introduction of new pharmaceuticals? That’s the key question for the pharmaceutical industry, because whoever’s faster to the market can provide a cure sooner – and get a head-start on the competition. Thanks to Enterprise Recipe Management (ERM), the answer is ‘yes‘. ERM significantly improves and speeds up the transfer of knowledge and technology from lab to production line.
The R&D cycles (NPDI) new product development and introduction in the pharmaceutical industry are time-consuming, costly, and difficult to manage. It can take years for new vaccines and medications to obtain registration. The R&D processes are highly complex and comprise hundreds of individual steps and labor-intensive clinical testing. An exception was the development of the COVID-19 vaccines: In just a few months, several vaccines that were both safe and effective were developed and registered. That happened because the development process was prioritised everywhere during the pandemic, and the labor input was correspondingly high. At the same time, researchers were able to build on good previous work and a high degree of collaboration unseen in the industry. But those were exceptional circumstances. The hope is that this momentum can be carried forward.
Mind the gap … and bridge it
Data silos and tribal knowledge are one reason for the time-consuming development process: Collaboration and knowledge-sharing are both strongly impacted by isolation throughout the entire process, from pharmaceutical development to commercial production. This applies from both a technological and a geographical perspective because development and production take place in different locations and often on different continents. At the same time, many separate IT systems are utilised to define and document the process. And if digitalisation is already in place, it usually only covers individual stages of the process; there isn’t an integrated approach to achieve the objective of speeding up NPDI. IT overhead is the result. Reducing this overhead and breaking down the existing data silos calls for ERM, the end-to-end solution that scientists in process development and production engineers can use to share their experiences with the product and production processes. Collaboration between process development and manufacturing is improved as a result. The transfer of technology from lab to shop floor, which often takes months, can be accelerated. A central ERM is a company’s digital backbone that enables a seamless transfer of data and knowledge, and this closes the gap between R&D and production. Data preparation and the upscaling of recipes for global manufacture are faster as a result, and overall efficiency is vastly improved. The advantages of a digital backbone for the entire production process are already widely seen in other areas. For example, in discrete industries such as the automotive industry or aerospace technology, so-called PLM systems (Product Lifecycle Management), which represent the entire product lifecycle and make it controllable, have been in use for many years.
The common thread in the clutter of data
Siemens has set itself the goal of making the digital transformation faster. The goal is to find solutions that work together seamlessly across communication structures and provide an integrated picture of products throughout their entire lifecycle. The underlying vision is centralised digital knowledge management. To achieve this, solutions need to be simple, modular, interoperable, and open. For its own portfolio of solutions, Siemens has made these principles the cornerstone of Siemens Xcelerator, its open digital business platform.
Digital transformation with ERM
ERM is an initial step toward centralised knowledge management: in other words, a platform based on Siemens Xcelerator that’s focused on the digitalisation production processes. As a process lifecycle management concept, ERM defines scientific and manufacturing process blueprints. It integrates all process data, in order to accelerate recipe development and improvement. It enables the transfer of knowledge and technology from process development to the scale-up plant and to an industrial scale commercial production. ERM makes formulation development leaner. Insights that are acquired can be used again. Control over various formulations, ingredients, formulation lifecycles, production processes is easier.
Also, knowledge about production facilities worldwide can be simplified because they’re controlled by a single system. This also means that companies have the ability to search globally for the best manufacturing options. Thanks to the ERM’s data-driven intelligence, production units can be flexibly and dynamically expanded at any time or relocated from one facility to another.
ERM as a platform
ERM is a modular platform that bundles solutions for the digitalization and the transfer of production processes for the process industry. Siemens has already invested billions of euros in an integrated portfolio of software and hardware products and services, laying the foundation for an end-to-end solution for pharmaceutical and life science companies. This includes the process and recipe designer Riffyn X, that was recently added to the extensive portfolio. This cloud-based solution gathers, records and contextualizes data throughout the entire biopharmaceutical and biotechnological development process. Riffyn X therefore allows the data to be used on a structured, systematic, and shared basis throughout the company. When gathering, contextualizing, and integrating the data, all the different features and versions of each recipe for every product, every department, and every location are taken into account. That makes Riffyn X a catalyst for ERM. Modeling tools like gPROMS and Simcenter STAR-CCM+ are also part of the platform and can be used to create digital twins of parts of the process at any point in time during the lifecycle. Using Riffyn X, gPROMS and Simcenter STARCCM+ allows combining real data and simulated data to speed up process development and validate digital models.
In the spotlight: Scale Up a process
ERM optimizes manufacturability across the pipeline: You can scale up with speed and agility from the lab through clinical trials to production while assuring quality, compliance and sustainability. For example, ERM – more precisely: Riffyn X – provides support for the development of the lap recipe. The first step is to design a process with flexibility and structure. This development goes faster through the collaborative and iterative approach of Riffyn X: It offers an intuitive graphical workflow and an ontology for reusability and consistency. The next step is to explore or confirm the hypothesis for the assays and experiments. Use Riffyn X to create or import Design of Experiment (DoE) based on a predefined process or sub process, plan your experiments and define conditions. After that, you have to contextualise and aggregate data from fragmented lab data (execute). Here Riffyn X helps by offering a flexible yet structured way to capture data from a diversity of laboratory data sources. It helps also to aggregate data in a simple process centric approach: Spreadsheet like table visualisation and editing, including formulas and automatic canvas. The next step is to accelerate data preparation and grooming (aggregation). That succeeds with the smart data management capabilities of Riffyn X: Clean, link, integrate and analyse data is easy. Additionally, it facilitates collaboration between process and data scientists. Finally, you have to create meaning out of experiment data (analyse). Riffyn X helps again: It delivers data in a vendor neutral data frame suitable for visualisation, machine learning, data pipelines, data analytics or business intelligence.
In summary, ERM is an essential step on the way to a digital enterprise. It helps accelerate processes and brings pharmaceutical companies closer to their goal of winning the race against time.
Author Bio
Since the beginning of March 2024, Maria Grahm has been responsible for Siemens pharmaceutical business, headquartered in Karlsruhe.
After a few years outside of Siemens, Maria returned in 2018 as Sales Manager for Smart Infrastructure and later held the role of General Manager for business unit Process Automation in Sweden and Nordics.
Over the course of her career, Ms. Grahm has held various leadership positions where she has driven strategic initiatives forward and facilitated collaboration between industrial companies, suppliers, and research partners. At the same time, she has gained extensive experience in the field of industrial automation and IT, with a focus on process industries such as pharmaceuticals, chemicals, and water and wastewater.
