With its expertise, Pentracor GmbH covers the entire life cycle of a therapeutic adsorber. We are happy to put this experience at your disposal. Whether you have a feasibility project, want a complete adsorber development, are looking for a contract manufacturer for adsorbers or need support in quality management - you have come to the right place. Below you will find a list of the services we offer. We would be pleased to make you a suitable offer.

Feasibility studies

Feasibility studies are smaller projects for the proof of concept. Our range of services includes

  • Development of detection systems
  • Coupling of ligands to matrices on a minimum scale (1 ml columns)
  • Review of target molecule binding
  • Examination of specificity
  • Checking the sterilisation
  • Documentation

Development projects

We develop a customised adsorber for you. The work programmes are adapted to the planned application (therapeutic adsorbers, adsorbers for research purposes, adsorbers for industry). We offer for you:

  • Development of detection systems
  • Coupling of ligands to matrices on a minimum scale (1 ml columns)
  • Optimisation of the coupling under consideration of production requirements
  • Characterisation of the coupled matrix (binding properties, capacity, specificity ...)
  • Development of a sterilisation protocol
  • Development of quality controls
  • Scale-up
  • Supervision of the biocompatibility studies
  • Compatibility studies
  • Stability studies
  • Documentation

Contract manufacturing of adsorbers

We manufacture therapeutic adsorbers for you in our clean room. Depending on your requirements we can take over the following work:

  • Optimisation of the coupling under consideration of production requirements (laboratory scale)
  • Scale-up
  • Implementation of production in clean room
  • Validation of the sterilisation protocol
  • Validation of quality controls
  • Validation of the production
  • Pilot productions
  • Production of adsorbers for clinical studies
  • Documentation

Quality management according to ISO 13485 (EU) and FDA standards

We offer you advice and support on the way to CE certification and FDA approval. We can offer you the following services:

  • Risk Management
  • Development of a QM system
  • Creation of technical documentation
  • European representative for therapeutic adsorbers

Distribution

With us you receive support for a successful market entry through

  • Transfer to our own distribution network
  • Medical product consultant for Germany
  • Procurement of sales partners abroad