Pharmaceutical engineering has traditionally focused on commercial production. However, changing product portfolios, shorter market launch times and high pressure on costs are demanding ever earlier and more intensive collaboration during the product life cycle. Fette Compacting therefore supports users as early as the research and development stage. Insights into this extended partnership are provided by the management team: Joachim Dittrich, Chief Executive Officer (CEO), Anke Fischer, Chief Financial Officer (CFO), Dr. Marten Klukkert, Vice President Customer Development Center, and Dr. Martin Schöler, Vice President Technology.

What strategy do you pursue in the area of research and development?

Joachim Dittrich: We have embarked on a journey to become a process partner for powder formulation and tableting for our customers. We support our customers in all processes from research and development to production. We are evolving as a close partner in process development, powder formulation and tableting, particularly in the area of continuous direct compression. The focus is always on the customer, whom we support from the optimal formulation and selection of the right process technology through to production and services. For us, this means a lively technology partnership.

Our corporate philosophy “Together – for quality of life” is indicative of the values at the heart of our actions during this journey: Our aim is to work together to make a key contribution toward improving the health and quality of life of people all over the world. This applies to our employees as well as in our collaboration with our customers. We want to inspire our customers and develop processes with them. More than ever, this involves early collaboration with combined expertise in order to define an optimal powder flow and to provide the most suitable production technology. 

Anke Fischer: I would like to pick up on the idea of common ground, which runs like a common thread through our daily activities worldwide. Whether at our headquarters in Schwarzenbek, at our second technology and production site in Nanjing (China), or at our other development site in Mechelen (Belgium), or at our many subsidiaries worldwide: our shared values form the foundation of our corporate culture and bind us together in the Fette Compacting family. This is something we take into account when looking for new talent. In this way, we ensure that we can continue to bring our philosophy to life in the future.

Joachim Dittrich and Anke Fischer, CEO and CFO at Fette Compacting

Why has this early and comprehensive collaboration become so important? What has changed?

Marten Klukkert: There are several factors to be mentioned here. Firstly, manufacturers’ product portfolios have changed significantly due to new product launches and expiring patents. In order to give customers a competitive edge, we need to work with them to shorten time-to-market, reduce the amount of powder used in product testing, and accelerate technology transfers. Secondly, pharmaceutical developments are increasingly moving toward large-scale serial production, but also toward highly-specific, customized therapies with smaller batches. This means that users need targeted and flexible technologies for a wide range of applications. Thirdly, austerity programs in many countries are increasing the pressure on drug prices. This, in turn, increases the need for highly-efficient machines and comprehensive process consulting.

Martin Schöler: In terms of technology, we aim to deliver the ideal process and the most efficient machine configuration for specific products. This covers the entire product life cycle and includes all processes, continuous manufacturing, and batch-to-batch. Our experience in both technologies allows us to compare them directly and identify the best way forward for our customers. We have compiled this knowledge in the new process database QED (Qualified Expert Database), which we are constantly adding to with new insights.

What technologies are decisive for the development phase?

Martin Schöler: In addition to the machine and tool portfolio, the focus is increasingly on integrated metrological solutions, such as nearinfrared spectroscopy as a reliable, robust and ultra-fast method for 100% analysis. In this way, we are moving beyond the boundaries of the production machine to support customers in their development process with a seamless system landscape.

Marten Klukkert: The technological offering starts with the productionrelated emulation of processes and the development of formulations in the laboratory. The Lab Solutions division provides users with state-of-the-art powder compaction analysis units, scales, micrometers, and breaking strength testers. As an analysis system, these modules provide a comprehensive image of the properties of the formulation and tablet. Once the optimum parameters have been determined in this way, we define a control strategy with the customer. Together, we emulate production processes and use embedded process analytical technology (ePAT) to ensure that powder blends and tablets are of a consistently high quality. Continuous direct compression in particular offers solutions for continuously monitoring processes in real time and reliably processing all kinds of products – from big pharma to smaller manufacturers.

What is the status of Continuous Manufacturing and what are the advantages for development?

Joachim Dittrich: By further developing continuous direct compression, we have made continuous manufacturing simple, flexible, controllable and economically attractive for pharmaceutical producers and manufacturers of food supplements. This makes it much easier for our customers to enter the market using this technology. Thanks to the continuous process, it is also possible to establish production capability for new products more quickly. To put it briefly: it has never been so easy to get started with continuous production.

Marten Klukkert: With the FE CPS (Continuous Processing System), we have moved even further in the direction of process development. Via a flexible process arrangement and a variable throughput range of five to over 200 kilograms per hour, we support our customers in their wide variety of development and production scenarios. The FE CPS can be easily integrated into existing production areas, works in a resource-saving manner, is highly digitized and easy to operate at the same time. As a result, it also forms a bridge for smaller manufacturers without their own development department who require a standard system for low-volume production.

Martin Schöler: We can report with great satisfaction that the FE CPS has already proven itself many times over since its launch. To date, we have received numerous inquiries, implemented a wide variety of product trials, and delivered several machines to the market. We have also received positive regulatory feedback for products that are to be continuously pressed. This shows that the FE CPS and ePAT will make it much easier to standardize processes.

What are the next steps on this journey?

Marten Klukkert: Together with our customers, we are currently looking at how the entire set-up needs to be organized in order to be positioned in the best possible and most flexible way for process development. To this end, we are also expanding our consulting services, which start well before a product launch and range from individual new launches to holistic performance optimization via fleet management.

Martin Schöler: It is also important that we link data applications for machines and processes even further. This is an elementary component of our development considerations and real digitalization in tablet production. Accordingly, we are processing increasing amounts of data as well as materials. Based on this data, customer requirements can be defined much more specifically, enabling us to determine tailor-made solutions.

Joachim Dittrich: Overall, our aim is not just to deliver machines and tools “to the yard.” Instead, we want to provide customers with turnkey solutions that enable them to bring their development projects into production more quickly while reacting more flexibly to changes.

Anke Fischer: In an effort to achieve all of this, we work closely at the international level. The FE CPS milestone is already the result of intensive collaboration between various teams, such as our developers in Belgium, our headquarters in Germany, and our sales specialists around the world, who are now presenting Continuous Manufacturing to all interested parties. This inspiring exchange and passionate cooperation demonstrates our team’s enthusiasm for the future while also revealing our greatest potential: our employees, who represent the main pillars of the company. To this end, we will continue to create a motivating working environment with exciting and challenging tasks, for which we will continuously develop the specific expertise of our employees.