Fette Compacting and SOTAX are now collaborating more closely within a strategic partnership. The two companies are combining their expertise in formulation, process, and analytical development to provide end-to-end support to manufacturers in the development of oral solid dosage forms (OSD). The goal is to more closely integrate pharmaceutical development and production processes, shorten development times, and ensure the quality and robustness of new products at an early stage.
The development of OSD products is characterized by close interactions: The properties of active ingredients and excipients influence the formulation and its processability; process parameters, in turn, affect critical quality attributes such as weight, hardness, active ingredient content, and release behavior. In many projects, however, formulation, process, analytics, and subsequent production are still handled sequentially and by different departments. When findings are not integrated until late in the process, this leads to additional coordination and testing cycles that can delay development and scale-up.
Fette Compacting and SOTAX address these interfaces. Analytical requirements, formulation development, and process design should be more closely integrated from the very beginning. Findings from the analytical phase are directly incorporated into the optimization of the formulation and manufacturing process. Conversely, changes to materials, formulations, or process parameters can be promptly evaluated for their impact on quality and pharmaceutical efficacy.
“When developing a tablet, the product, process, and subsequent production must be considered together from the very beginning,” explains Dr. Marten Klukkert, Chief Customer Officer at Fette Compacting. “Together with SOTAX, we combine our tableting and process expertise with comprehensive analytical expertise. This allows us to create a more solid foundation for decision-making, reduce the number of iterations, and support our customers in efficiently scaling up robust formulations to production.”
Complementary Expertise from Lab to Production
Fette Compacting contributes its expertise in the development and industrial manufacture of tablets. This includes the characterization of powders and formulations, the development of suitable formulations and process parameters, and the optimization of tableting processes. The range of services extends from material-friendly laboratory testing through scale-up and technology transfer to the optimization of ongoing production processes.
SOTAX complements these services with expertise in analytical development, method development and validation, and pharmaceutical quality control. Key areas of focus include tests to evaluate active ingredient release (dissolution), tests to determine the uniformity of active ingredient content, and the assessment of various physical product properties throughout the process from powder to finished product.
As a result, these tasks are directly interlinked: Fette Compacting determines how a product should be formulated and how the manufacturing process should be designed to ensure that the tablet can be produced reliably and reproducibly. SOTAX provides methods, technologies, and services that enable quality and performance to be reliably measured, evaluated, and documented.
“Analytical development and process development influence one another and should therefore not be considered in isolation,” says Rolf Benz, President of the SOTAX Group. “Through our partnership with Fette Compacting, we can align analytical concepts even more closely with formulation, tableting, and subsequent production requirements. This provides our customers with coordinated support that transcends traditional departmental and development boundaries.”
Analytics and Process Development Closely Integrated
The strength of the partnership is evident in the joint development cycle. If, for example, a tablet’s release profile deviates from the target values, the experts investigate possible causes related to material properties, formulation, and process parameters. Fette Compacting can make targeted adjustments to the formulation or the tableting process; SOTAX immediately verifies how the changes affect active ingredient content, release, and other quality characteristics.
The same principle applies to both major and minor changes – from switching to continuous manufacturing to changing a raw material supplier. The steps of characterization, formulation, tableting, analysis, optimization, and scaling are more closely coordinated. Quality is thus not merely checked at the end but integrated into product and process development from the very beginning. Unnecessary trial-and-error cycles are to be avoided, and decisions are to be made based on a broader data set.
For pharmaceutical manufacturers, this means fewer handoffs and less coordination effort, faster access to insights into the relationships between materials, processes, and product quality, as well as a more robust foundation for scale-up, validation, and production ramp-up. Depending on the project requirements, experts from both companies will collaborate within coordinated structures. Customers retain dedicated points of contact while benefiting from a seamless approach.
Further Development of the Process Partnership
For Fette Compacting, this collaboration is another building block of its “Together – from lab to production” strategy. The company is expanding its process partnership to include additional expertise in analytical development and the testing of critical quality attributes. SOTAX is complementing its expertise in analytics, laboratory automation, and data management with direct access to comprehensive knowledge in formulation, tableting technology, scale-up, and commercial production.
The partnership builds on a long-standing collaboration and established trust. Both companies aim to gradually expand joint customer projects and, in addition, further develop equipment and data interfaces as well as joint development activities. The goal is to establish a consistent information base from early characterization through ongoing production – and thereby enable faster, more informed, and more robust development of OSD products.