DE CONTACT OUR BUSINESS COMPETENCE CUSTOMERS DIFFERENTIATORS RESPONSIBILITY INTELLIGENCE CENTER CAREER PRODUCT PERFORMANCE Our technological expertise is in Product Performance COMPETENCE // PRODUCT PERFORMANCE 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. We provide the technical expertise that is needed to solve design-based product problems by identifying process improvement potential and corresponding solutions, and successfully providing technical troubleshooting for all product and manufacturing related issues. PRODUCT DEVELOPMENT Development Phase of the Product Life Cycle 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. 1. CUSTOMER-FOCUSED INTERFACES 2. ONE-STOP SERVICE 3. BEST-IN-CLASS DEVELOPMENT CENTER Development Phase of the Product Life Cycle Development Service 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 Development Center Project Manager Expert Formulation Development Manager Analytical Development Pilot Plant In-Process Control The Highest Level of Technological Expertise State of the Art + Product Performance Blending x Bohle Free Fall Blender (0.5-400 Liter; max. 150kg) Lödige High Shear Mixer (5, 10, 20, 130, 300 Liter; max. 100kg) + Product Performance Granulation x 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 + Product Performance Hot Melt Granulation x Vacumix Melting and Blending Equipment Aeromatik MP3/4 (10-40kg) + Product Performance Hot Melt Extrusion x Leistritz Twin Screw Extruder, Type: ZSE 18-HPE, screw diameter 18mm Thermo Fischer Pharma 11mm Extruder + Product Performance Compression Encapsulation x Compression: Kilian T100, T200, S250 ZS-M Encapsulation: Bosch GKF 702, Bosch Checkweigher KKE 2500 + Product Performance Film-Coating and Sugarcoating x 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 formula which can be manufactured simply and cost-effectively on a commercial scale. Our unique and impressive staff is comprised of over 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.” Dr. Eike Cordts Director, Business Unit - Development PRODUCT TRANSFER 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 hand-off. Rather, it is a two-way transfer of knowledge between contract giver and receiver. Product transfer is 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. Product Transfer and Quality 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 customer's product until validation is successfully finalized The Transfer Phase Sets the Stage for Manufacturing PRODUCT TECHNOLOGY 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 life-cycle. The department comprises Technical Product Support, Bulk Manufacturing Process Excellence, Packaging Process Excellence, and Packaging Process Design. TECHNICAL PRODUCT SUPPORT BULK MANUFACTURING PROCESS EXCELLENCE PACKAGING PROCESS EXCELLENCE Want to know more? 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