Our Services
Our expertise covers the whole life cycle of a therapeutic adsorber and we gladly provide our experience to you. No matter if you want to do a feasibility project or a full-fledged adsorber development, if you are looking for a contract manufacturer for adsorbers or if you need support for your quality management, you've come to the right place. Below you will get an overview of our services. We would be pleased to submit an offer fulfilling your needs.
Feasibility Studies
Feasibility studies are small projects for the proof of concept. Our spectrum of service includes:
- Development of detection systems
- Coupling of ligands to matrices on a small scale (1 ml columns)
- Review of the target molecule binding
- Examination of the specificity
- Verification of the robustness against sterilization
- Documentation
Development Projects
We develop adsorbers specifically designed for your needs. Depending on the intended application of the adsorber (therapeutic, research, industry) the work plans will be adjusted. We can offer you:
- Development of detection systems
- Coupling of ligands to matrices on a small scale (1 ml columns)
- Optimisation of the coupling with regards to the production requirements
- Characterisation of the coupled matrix (binding characteristics, capacity, specificity ...)
- Development of a sterilisation protocol
- Development of quality controls
- Scale up
- Support of the biocompatibility examinations
- Compatibility studies
- Stability studies
- Documentation
Contract Manufacturing of Adsorbers
We produce therapeutic adsorbers in our clean room for you. Depending on your requirements we can take over the following work steps:
- Optimisation of the coupling with regards to the production requirements (laboratory scale)
- Scale up
- Implementation of clean room production
- Validation of the sterilisation protocol
- Validation of quality controls
- Validation of the production process
- Pilot productions
- Production of adsorbers for clinical studies
- Documentation
Quality Management Following ISO 13485 (EU) and FDA Standards
We can offer counseling and support on your way to the CE certificate and FDA admission. The following services can be provided:
- Risk management
- Setup of a QM system
- Establishment of a technical documentation
- European representative for therapeutic adsorbers
Sales
We support your successful market entry by:
- Integration of your product into our sales network
- Providing medical product consultants
- Mediation to sales partners in foreign countries
