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 transfer. For Rottendorf, this also means providing the technical expertise that is needed to solve design-based product problems, identifying process improvement potential and corresponding solutions, and successfully providing technical trouble shooting for all product related and manufacturing related issues.
Development Phase of the product lifecycle
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 improved availability of poorly soluble APIs.
Customers can choose from individual or complete services, including process and formulation optimization, upscaling, clinical trial manufacturing, analytical method development, stability studies, and regulatory support. Rottendorf’s development expertise is grounded in the knowledge of commercial manufacturing operations and requirements. We formulate with the end in mind – delivering formulations that are ready to be easily and robustly manufactured at a commercial scale.
- Single-Point of contact for customers
- High technical and pharmaceutical expertise
- Strong project management skills
- Dedicated project team for development, upscaling and CTM supply
- High flexibility to support customer needs
- Tailor-made customer solutions
- Development, Upscaling and CTM supply on the same equipment with dedicated development staff
- Strong technical expertise
- Efficient in providing solutions and trouble shooting
- Reliable and on-time CTM supply
- Analytical method development, validation and release testing
- Short development timelines until clinical trial manufacturing
- GMP and FDA approved environment
- Complementary equipment for development, upscaling and commercial manufacturing
- All technologies for development of solid dosage forms available
- Focussed on robust manufacturing process from formulation development until later commercial manufacturing
- Short development timelines
- Low-risk of failure from development to commercial
Best-in-class Development Center
Development Phase of the product lifecycle
- Process and Formulation Design
- Process and Formulation Optimization
- Process Up-Scaling
- Clinical trial manufacturing
- Commercial manufacturing at small scale
- Analytical Method Development
- Stability Studies
- Regulatory Support
- Project Manager
- Expert Formulation Development
- Manager Analytical Development
- Pilot Plant
- In-Process Control
The Highest Level of
State of the Art
- Bohle Free Fall Blender (0.5-400 Liter; max. 150kg)
- Lödige High Shear Mixer (5, 10, 20, 130, 300 Liter; max. 100kg)
- Fluid Bed Granulation: Glatt GPCG 3 (1-5kg), Aeromatic MP3/4 (10-50kg)
- High Shear Granulation: Diosna P1, P4, P10, P 25, P60 (0.2-25kg)
- Roller Compaction: Gerteis Roller Compactor
- Pelletization: Nica Extruder E140, Spheronizer S450
Hot Melt Granulation
- Vacumix Melting and Blending equipment
- Aeromatik MP3/4 (10-40kg)
Hot Melt Extrusion
- Leistritz Twin Screw Extruder, Type: ZSE 18-HPE, screw diameter 18mm
- Thermo Fischer Pharma 11mm Extruder
- Compression: Kilian T100, T200, S250 ZS-M
- Encapsulation: Bosch GKF 702, Bosch Checkweigher KKE 2500
- Filmcoating: Bohle BFC 50 (10-55 Liter), Driam Driacoater (3-6 Liter)
- Sugarcoating: Brucks Vessels (5-60kg)
- Pelletcoating: Glatt GPCG-3 Wurster (1-3kg), Midi-Glatt (0.2-0.8kg), Aeromatik MP 3/4
“Our expertise in business development is based on our knowledge of economic manufacturing processes and requirements. We keep the ultimate objective in mind as we prepare the formulation – and deliver formulae which can be manufactured simply and cost-effectively on a commercial scale. Our unique and impressive staff is comprised of 40 formulation scientists who use their many years of experience to contribute to the success of the best formulations so that a wide range of solid dosage forms can be offered”
Quality by Product Transfer
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 handoff, 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, Rottendorf’s approach to Product Transfer as an exchange rather than a handoff means continuous engagement with our clients.
Product Transfer and Quality Ensurance
To ensure quality of a Product Transfer, Rottendorf provides:
- A designated project leader for the customer throughout the transfer phase
- Management of all external/internal activities throughout the transfer phase
- Design of efficient and robust manufacturing processes
- Detailed risk evaluation
- Management of the timeline and budget control
- Responsibility for the customers’ product until validation is successfully finalized
The Transfer Phase
It sets the stage for the manufacturing process
Our competence is your advantage
With the Product Technology department Rottendorf has created a knowledge hub for all product related matters during the commercial phase of the product lifecycle. The department comprises the departments Technical Product Support, Bulk Manufacturing Process Excellence, Packaging Process Excellence and Packaging Process Design.
Commercial Phase of the product lifecycle
Rottendorf’s Technical Product Support, as a part of the TPO Center, is 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.
Technical Product Support/Quality Ensurance
To ensure quality, Rottendorf provides:
- One designated project leader for all technical product related issues
- Efficient resolution and ownership of product related issues
- Change Management
For the commercial bulk manufacturing, and for the commercial packaging as well, Rottendorf has established a dedicated team for the continuous optimization of the manufacturing processes. To maintain robust and stable manufacturing processes is essential for keeping our promise to our clients to always deliver on time.
For the commercial packaging, and for the commercial bulk manufacturing as well, Rottendorf has established a dedicated team for the continuous optimization of the manufacturing processes. To maintain robust and stable packaging processes is essential for keeping our promise to our clients to always deliver on time.
To meet the special requirements of packaging operations, Rottendorf has established another dedicated team for the packaging department to perform the format parts qualification and to supervise the implementation of new artwork, for both new and exisiting products.