We have all standard equipment for the production of solid dosage forms, such as machines for dry and free-flow granulation and direct tabletting. In addition, we have special expertise in formulation to improve the bioavailability of poorly soluble active pharmaceutical ingredients. For this purpose, we use technologies such as melt extrusion or melt granulation. We also pay special attention to the development and production of mini tablets and pellets.
Hand in hand with this is the development of the corresponding analytical methods in our "Analytical Technology" competence centre.
Our development competence is based on our knowledge of commercial production processes and requirements. We develop and deliver formulations and analytical methods that are fit for purpose and can be easily and robustly used in commercial manufacturing.
More than 40 highly qualified formulation scientists and analytical experts contribute their many years of development experience to each product, thereby actively contributing to project success. Through our Total Process Ownership (TPO©) service concept, the customer can rely on fully comprehensive support along the entire process chain.
0.5 to 150 kg
solid dosage forms possible in product development
Customers are free to choose the services they require from our broad portfolio of services. These include process and formulation optimization, upscaling, manufacturing for clinical trials, analytical method development, stability testing and regulatory support.
- Formulation and process development and optimization
- Clinical sample manufacturing phase 1 to phase 3
- Analytical method development
- Stability studies
- Packaging development
What distinguishes us as CDMO
In our cooperation with clients, they are in the center of our activities from the very beginning. In addition to the high technical competence of our employees, we rely on our service concepts TPO©, TTM and TSI in the product development.
Together with our special corporate structure, we generate significant added value for our customers.
- Dedicated project manager
- High technical and pharmaceutical competence
- Highest flexibility to support and implement customer needs
- Tailored customer solutions
- Dedicated project team for development, upscaling and CTM supply
- Strong project management skills
- Development, upscaling and CTM supply in our GMP Pilot Plant
- Reliable and timely CTM supply
- Analytical method development, stability studies, validation and release testing
- Short development time until clinical study
- Efficient in diagnosis of failures and creation of solutions
- GMP and FDA certified environment
- Quality by design development approach
- Highest planning flexibility
- All technologies for solid dosage form development are available
- Lab Scale to Pilot Scale
- Focused on a robust manufacturing process from formulation development to subsequent commercial production
- Short development times
- Cost effective
- High Shear Granulation:
Diosna P1 / VAC 10+60 , Midi-Glatt (+ Wurster) [nonGMP], GPCG 3 (+ Wurster), Aeromatik MP 3 / 4 (+ Wurster)
- Free Fall Blender: Bohle PM 400, Bohle LM 20
- Roller Compactor: Gerteis Mini-Pactor
- Extruder/Spheronizer: GEA NICA E140, GEA NICA S450
- Hot melt twin screw extruder: Leistritz ZSE 18HP, ThermoFischer Pharma 11 [nonGMP]
- High Shear Granulation:
- Tabletting Euro B & D: Korsch XL200, Korsch X3, Fette 102 i
- Capsule filling: Bosch GKF 702
- Coater: Bohle Film Coater (BFC) 5, Bohle Film Coater (BFC) 50, Bohle Film Coater (BFC) 200
- Tablet printing: R. W. Hartnett Delta-Printer
Our expertise is based on our knowledge of economic manufacturing processes and requirements. When developing the formulation and associated, analytical methods, we always keep the goal in mind - the formulations supplied can be easily and robustly transferred to commercial manufacturing. Along the way, the customer and his requirement are at the center of everything we do.
Dr. Eike Cordts, Director, Business Unit - Manufacturing Science & Technology
qm Pilot Plant
clinical sample batches and more
Contact us or use our contact form to get in touch with us. No matter which way you choose, we are here for you and answer your questions!