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Parenterals are highly demanding dosage forms. Common challenges of biotechnological products are in many cases very high or very low concentrated, adsorptive or instable drug substances, aggregation and complex filling behaviour. We face these challenges with our longstanding experience in the development, production, filling and analytics of liquid parenteral dosage forms. Apart from that, we have the equipment to optimize the formulation regarding processability at an early stage with only little amounts of drug substance.
Should the stability of the drug substance be inadequate in a liquid or suspended state, we have the expertise and equipment to develop a freeze-dried product. For liquid as well as freeze-dried formulations we can streamline formulation development with efficient high-throughput-screening methods.
Services for the development of parenterals:
- Formulation high-throughput-screening
- Filling in low particle environment
Parenterals need to comply with a high standard in patient safety. Stability of the drug substance, sterility and absence of particles throughout the shelf life have to be guaranteed. In each of these aspects, we have up to date knowledge and can provide the respective technologies including the development and establishment of different activity and microbiological assays. Besides, we are able to check structural integrity using different spectroscopical methods and detect particles ranging from the visible via the subvisible to the nanometer range.
To get the full picture, we are equipped to apply orthogonal methods in many cases.
Services for the analytics of parenterals in liquid or solid dosage forms:
- Pharmacopoeial microbiological methods
- Particle analysis
- Structural analysis of complex biological molecules
- Water content measurements
- Measurement of freezing point and glass transition temperature
- Activity measurements
- Concentration measurements
- Characterisation of the drug substance