Orals

Processes

State of the art equipment and decades of experience with liquid, semi-solid and solid oral dosage forms enable us to develop and manufacture a broad variety of drug products at different scales. Above all, our expertise and technology platforms comprise the formulation of complex biological and biotechnological drug substances as well as live microbial cells. Usage of high-throughput-screening methods streamlines the drug product development with regard to time and cost-efficiency. We are also equipped to formulate oxygen sensitive or biosafety level 2 drug substances. 

Services for the development and manufacture of liquid, semi-solid and solid oral dosage forms for biological and biotechnological drug substances:

• High-throughput-screening of liquid protein formulations
• High-throughput-screening of live biotherapeutic formulations
• Liquid filling
• Spray- and freeze-drying
• Powder processing
• Granulation
• Tabletting
• Film-coating
• Sugar-coating
• Encapsulation
• Controlled manufacture of emi-solids
• Scale-up and transfer to production

Analytics

The quality of the final product depends to a high degree on the robustness of the production process, but also on the characteristics of the preliminary stages (intermediates). Therefore, it is important to generate as much product understanding as possible starting in the early development phases. Careful, robust and forwarded analytics are essential in every production step. Our analytical equipment ensures extensive characterisation of raw materials, intermediates and final products. Apart from universal test methods, we also offer the development of activity measurements, dissolution assays and concentration determinations. Moreover, we can develop and apply different methods to resolve the structural integrity of the drug substance.

Our state of the art equipment for particle analytics delivers detailed information about the distribution, size and shape of particles in powders as well as powder blends or suspensions. In liquid dosage forms, we are able to detect smallest aggregates even in the nanometer scale.

To get the full picture, we are equipped to apply orthogonal methods in many cases.

Services for the analytics of liquid, semi-solid and solid oral dosage forms:

• Pharmacopoeial characterisation of liquids, semi-solids and solids
• Structural analysis of complex biological molecules
• Particle analysis
• Water content measurements
• Activity assays
• Concentration measurements
• Characterisation of the drug substance