sponsoredFrom Lab to Production Fette Compacting: Equal Partnership as a Success Factor

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Fette Compacting GmbH

Fette Compacting is on a successful path and presents itself confidently as a strategic partner for the pharmaceutical and nutrition industries. We inquired into how the company embodies its new orientation: “Together — from lab to production.”

After its appearance at Achema 2024, the company’s message should be well-received in the market: Fette Compacting has positioned itself as a process partner for pharmaceutical production and has shifted away from the image of merely a machinery manufacturer. This strategic process began two years ago, and since the beginning of this year, it has also become visible in the company’s leadership structure. Alongside CEO Joachim Dittrich and CFO Anke Fischer, Dr. Marten Klukkert now completes the trio as Chief Customer Officer.

At Fette Compacting, with ten years of service, he can already be regarded as a veteran. For the past two years, he has been responsible as Vice President of the Customer Development Center for the five Competence Centres located in Germany, the USA, Brazil, India, and China, and he has been closer to pharmaceutical customers than anyone else in the company.

His new role as a “customer communication expert” is thus tailor-made for him — on top of this, he now also carries a significant amount of strategic responsibility: embedding customer orientation into the DNA of the company, further developing the range of services and process partnerships, and implementing the corresponding structures.

Robust Processes and Rapid Scale-Up

Five Questions to Dr. Anna Novikova

What do you see as the challenges in process development?

Novikova: Based on our experience, the core challenge in process development concerns the costs and availability of limited powder material. The process often takes too long, and too much material is wasted; in some cases we are talking about several hundred kilograms before it transitions from lab scale to commercial production. Our clients want rapid technology transfers and do not want to go through multiple scale-up steps. Furthermore, a process should operate robustly over an extended period and require minimal intervention from the operator.

And how is this achieved?

Novikova: The aim is to develop the process so that it can accommodate changes in raw materials and deliver a tablet that meets the customer’s quality requirements over many years. We look at the critical material attributes (CMAs) that are crucial for product quality and link these CMAs with the critical process parameters (CPPs). We employ the concept of Quality by Design, developing a design space for the customer: Our Lab Solutions service is ideal for clients who currently do not have the capacity to focus on Quality by Design in process development.

Where do you see the technological strength of Fette Compacting?

Novikova: A prerequisite for Quality by Design is an understanding of processes and materials. Our strength lies in our ability to relate powder properties to the manufacturing process (e.g. the tablet pressing process) and to take a holistic view of the problem. This is precisely why we have the F Lab 5 and F Lab 10 in our portfolio. They allow us to analyse the powder compression behaviour very accurately and lay the foundation for the step into process development. Subsequently, we simulate process steps using emulators and obtain real process data. This enables us to make predictions regarding the later production process.

What benefits do customers gain from the use of emulators?

Novikova: The process development is significantly faster; we only require small amounts of material for analyses while still obtaining accurate predictions. Another advantage for the customer is that they do not have to block capacities on their production machines for development purposes. In the long term, the customer is empowered to validate their formulations and process parameters early and rectify issues already in the development phase. Overall, we help customers to enter the market faster and to develop robust processes.

What role does PAT play nowadays?

Novikova: In fact, Fette Compacting adopted PAT development back in 2004, when the FDA began to promote the topic. Nevertheless, we believe that the full potential of PAT is not yet being utilised, due in part to the complexity of some systems. We have developed the embedded process analytical technology (ePAT). This technology is fully integrated into the tablet presses, and the sensors can be installed via plug-and-play. This makes process control simple, robust, and efficient — both in batch and continuous processes.

Now the Transformation is Also Visible at the C-Level

Customer orientation is a buzzword that many companies proudly boast — machinery manufacturers also like to present themselves as solution providers. However, Fette Compacting has been pursuing this initiative with great determination for the past two years, including a cultural shift within the company. The newly created position of CCO now underscores how seriously the leadership trio takes the transition from a tablet press manufacturer to a strategic partner of the pharmaceutical industry.

“Our customers now demand more than just a technically perfect machine from us; they expect functioning processes,” explains Klukkert. He has observed this market development for years, and the motto presented at Achema, “Together — from lab to production”, represents the ambition that Fette Compacting has worked out for itself. This entails support throughout the entire lifecycle of the OSD from formulation and process development to scale-up, production, and later process optimisation.

As a first necessity, the Fette Compacting team has been building for the past two years and has established new structures. Of course, the sales department is still the a point of contact for customers, but the purely commercial mindset is being replaced by a focus on the core challenges of the customer and the overall solution that should emerge later. Specifically, this means breaking down the traditional concept of functional areas and moving away from pure machinery sales. “We engage with pharmaceutical customers as an interdisciplinary, content-driven team and discuss the best process solution,” emphasises the CCO. It is crucial to initiate discussions with the pharmaceutical partner at a time when everything is still open from a technological perspective. Often, this is around clinical phase IIb, where dosage form and levels have been determined, but the production method can still be discussed.

Therefore, in these early project phases, alongside the sales expertise, application specialists, technical project management, and experts from the Process Consultancy Team join in. Led by pharmaceutical expert Dr. Anna Novikova, this team sees itself as a sparring partner, guiding customers through the entire lifecycle of the pharmaceutical product, from the initial laboratory characterization and properties of the powder to be tableted, through formulation and process development, to a robust production process and later optimisation.

“We help the customer understand their powder,” summarizes Novikova succinctly. She has the best qualifications for understanding powder. Eight years ago, she joined Fette Compacting as a PAT expert when they were looking for an expert in spectroscopic analytics in tablet formulation — fittingly, the subject of her doctoral thesis. One of the first in the field, she was involved in the development of the ePAT system, a key component in the continuous dosing-mixing unit FE CPS. The combination of mechanical engineering and pharmaceutical technology continues to fascinate her. This interaction — pharmaceutical knowledge, process expertise, and the know-how of the machinery builder — is considered by Fette Compacting to be the key to success in discussing the best solution with customers at eye level.

That the “collaboration between pharmaceutical expertise and mechanical engineering competence” works is evidenced by Anna Novikova and Marten Klukkert themselves. For his PhD in pharmaceutical technology, Klukkert researched which parameters solid drug formulations must meet to be processed into tablet presses and to have their quality tested directly in the production process. Later, at Fette Compacting, he, along with Novikova, was involved in the development of the Continuous Processing System FE CPS, which serves as a blueprint for the concept of process partnerships and as a catalyst for the idea of expanding into process development. It is no coincidence that both are enthusiastic advocates of continuous production. “Continuous production adapts to different production scenarios and thereby offers optimal conditions for process development and manufacturing,” both emphasise.

Changes in the Pharmaceutical Industry as a Catalyst for Continuous Production

The pharmaceutical industry is currently undergoing significant changes, which are promoting transformation towards continuous manufacturing: the product portfolios of original manufacturers are shifting considerably. While there still are large-volume products, the success of cell and gene therapies is leading to a significant increase in highly specific, customized therapies with smaller batch sizes.“To provide our customers with competitive advantages, we must reduce time-to-market, minimise powder usage in product testing, and expedite the technology transfer,” explains Klukkert. Additionally, the frugal health policies of many countries are reducing drug prices and, as a result, profit margins for companies. Highly efficient machines and process consulting, as offered by Fette Compacting, can alleviate some of this pressure.

As a result of this dynamic, there is also a growing motivation within the traditionally slow solid production to look beyond the obvious — after all, everyone wants to become faster, more flexible, and more efficient. A key insight from Klukkert: “Many companies are currently working to position themselves with a future-oriented approach, making fundamental changes, and rethinking entire plant structures.” This presents a prime opportunity for the makers at Fette Compacting to leverage their process knowledge and over 75 years of tablet press experience as consultants and service providers. “In many areas, we see that simplified processes and complexity reduction offer significant added value to the customer and can in many cases also minimise risk.” This reiterates an argument for continuous production, as compared to granulation-based processes, direct compression from the doser/mixer into the tablet press saves process steps, making production leaner and more energy-efficient.

Global Competence Centres Where the Customer Needs Them

An important part of the “Together — from lab to production” concept is the global Customer Development Centres. Here, all available tablet technologies are maintained, and process experts are on hand to assist pharmaceutical customers when testing a new technology. The digital foundation of the comprehensive process consulting is the Qualified Expert Database (QED), which accumulates experiences from seven decades of tablet press expertise and is continuously enriched with new insights. “This allows us to quickly determine the best processes and machine configurations,” emphasises Klukkert.

sponsored Powder Formulation And Tableting

From Machine Manufacturer to Process Partner: Fette Compactings New Formula For Success

The technology park of the Customer Development Centres offers another benefit: since there is always a risk of things going wrong in the early phases of drug development, collaboration with Fette Compacting shifts investment risks for pharmaceutical companies to the end of the development process. By this stage, the wheat has usually been separated from the chaff, and the risk of total failure is significantly lower. Klukkert clarifies that during the process development phase, the production volumes needed for market supply can only be estimated roughly, and he adds: “When the customer enters into a partnership with us during the early clinical phase, they have a very clearly defined effort for developing the process technology. If successful, we then jointly take the next step,” explains Klukkert. This could involve ramping up production capacities while concurrently training production teams to build machine-side expertise. Ideally, Novikova adds, a partnership is established that lasts throughout the entire lifecycle of production and also includes optimisation and maintenance. The interest is high. Fette Compacting has thus already made significant strides in implementing its new strategy and achieved initial successes. Next on the agenda is an expansion of the Customer Development Centre in Schwarzenbek, Germany. Once the clean rooms are completed, it will also enable the processing of highly potent active ingredients, thereby offering customers an expanded testing option.

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