- Bohle Free Fall Blender (0.5-400 Liter; max. 150kg)
- Lödige High Shear Mixer (5, 10, 20, 130, 300 Liter; max. 100kg)
Rottendorf eliminates the need for customers to provide expertise on product technology and technical operations as we fully understand the galenical design of the product and all critical parameters during technology transfers. We provide the technical expertise that is needed to solve design-based product problems by identifying process improvement potential and corresponding solutions, and successfully provide technical troubleshooting for all product and manufacturing related issues.
Rottendorf Pharma designs and develops solid dosage formulations from 2 kg to 150 kg in our state-of-the-art Development Center that is both GMP compliant and FDA approved – something not all CDMOs can offer. Technology for hot melt extrusion, hot melt granulation, and the development and production of pellets is available. Special emphasis is placed on the improved availability of poorly soluble APIs.
Customers can choose from individual or complete services including process and formulation optimization, up-scaling, clinical trial manufacturing, analytical method development, stability studies, and regulatory support. Our development expertise is grounded in the knowledge of commercial manufacturing operations and requirements. We formulate with the end in mind by delivering formulations that are ready to be easily and robustly manufactured on a commercial scale.
Dr. Eike Cordts
Director Product Development
Product Transfer involves transferring to the CDMO the manufacturing and packaging processes as well as the analytical methods – whether for established products already on the market or newly approved drugs. It is crucial that the process of transferring products from a pharmaceutical sponsor to the CDMO is carefully planned and well executed. Product transfer is far more than a hand-off, rather, it is a two-way transfer of knowledge between contract giver and receiver, for a dialogue to fully evaluate risk and optimize processes so that both the final drug product and the contract experience meet the client’s expectations.
Rottendorf Pharma follows precise procedures and takes ownership of processes to ensure a successful Product Transfer. Throughout the transfer phase, our approach to Product Transfer is an exchange rather than a hand-off which means continuous engagement with our clients.
With the Product Technology department, Rottendorf has created a knowledge hub for all product related matters during the commercial phase of the product life-cycle. The department comprises Technical Product Support, Bulk Manufacturing Process Excellence, Packaging Process Excellence and Packaging Process Design.
Rottendorf’s Technical Product Support (TPS), a part of the TPO Center, is the first point of contact for clients in case technical anomalies (so-called “issues”) are detected during the commercial production. In such cases the TPS project managers take ownership and solve the issue jointly with our client and the specialist departments involved. The solving of those issues and the resulting corrective and preventive actions follow precise standardized processes.
To ensure quality, Rottendorf provides: